Postoperative Pain and Convalescence in Living Kidney Donors Laparoscopic Versus Open Donor Nephrectomy: A Randomized Study

Transcription

1 American Journal of Transplantation 2006; 6: Blackwell Munksgaard C 2006 The Authors Journal compilation C 2006 The American Society of Transplantation and the American Society of Transplant Surgeons doi: /j x Postoperative Pain and Convalescence in Living Kidney Donors Laparoscopic Versus Open Donor Nephrectomy: A Randomized Study M. H. Andersen a,, L. Mathisen b, O. Øyen a, B. Edwin f, R. Digernes c, G. Kvarstein c, T. I. Tønnessen c,a.k.wahl d, B. R. Hanestad e and E. Fosse f a Department of Surgery, b Department of Thoracic and Cardiovascular Surgery, c Department of Anesthesiology, Rikshospitalet-Radiumhospitalet University Hospital, d Oslo University College of Nursing, e Department of Public Health and Primary Health Care, University of Bergen, f The Interventional Centre, Rikshospitalet- Radiumhospitalet University Hospital, Norway Corresponding author: M. H. Andersen, marit.andersen@rikshospitalet.no The aim of the present study was to compare postoperative pain and convalescence in patients randomized to laparoscopic or open donor surgery in a prospective, controlled trial. The donors were randomly assigned to undergo laparoscopic (n = 63) or open (n = 59) donor nephrectomy. Our end points were amount of administered analgesics in the recovery period, postoperative pain on the second postoperative day and at one month after surgery and duration of sick leave. There was a significant difference in favor of the laparoscopic group regarding administered analgesics on day of surgery (p < 0. 02). No difference was observed between groups regarding self-reported pain on the second postoperative day. One month post donation, significantly fewer donors in the laparoscopic group reported pain (p < 0. 02) or had used analgesics (p < 0.05). The duration of sick leave was significantly shorter in the laparoscopic group (p = 0.01). The laparoscopic group experienced a more rapid convalescence and a shorter period of sick leave. Although immediate postoperative pain can be managed efficiently regardless of procedure, a lower consumption of opioids and incidence of pain in the convalescent period suggest a clinically relevant patient-experienced benefit from a successful laparoscopic procedure. Key words: Convalescence, laparoscopy, living donor nephrectomy, postoperative pain Received 3 November 2005, revised and accepted for publication 24 January 2006 Introduction Live donor nephrectomy represents a major physical trauma for kidney donors, including postoperative pain and discomfort in the convalescence period (1 6). In an effort to remove some of the disincentives to live donation, Ratner et al. performed the first laparoscopic live donor nephrectomy in 1995 (6). In Norway living kidney donors account for more than 40% of all renal transplantations (7) and at our single national center open nephrectomy has been the established procedure. However, in 1998 laparascopic donor nephrectomy was introduced and performed in selected donors. Several non-randomized studies investigating postoperative pain and convalescence have shown laparoscopy to be superior by comparing laparoscopic and open donor nephrectomy (8 13). A few shorter randomized series has also been presented (14,15), mostly with the same conclusions, in favor of laparoscopy. In 2000, an Australian research group performed a systematic literature review of laparoscopic and open living donor nephrectomy and concluded that the evidence base was inadequate to make recommendations regarding surgical technique (16). On this background, we performed the largest randomized study so far, by assigning 122 donors to laparoscopic or open surgery. The first report from this study was published in May 2005, focusing on donor safety and postoperative complications and reoperations (17). The present paper emphasizes postoperative pain and convalescence. Since postoperative pain is an obvious disincentive for living kidney donation, this is an important part in the evaluation of laparoscopic versus open donor nephrectomy. Furthermore, exploration of the donors pain experiences may enhance the understanding of the trauma caused by these two different procedures. We hypothesized a priori that donors undergoing laparoscopic surgery are administered less postoperative analgesics, experience less pain in the postoperative period and have a shorter sick leave compared to donors undergoing open surgery. Materials and Methods Patients Consecutive donors were asked to participate in the study by local nephrologists throughout the country during initial evaluation for donation. Potential donors fulfilling existing criteria for donation and with a single, left 1438

2 Outcomes in Laparoscopic Versus Open Donor Nephrectomy renal artery were considered eligible. A total of 240 living donor nephrectomies was performed during the inclusion period. Among 118 donors not included in the study, two were laparoscopic donor nephrectomies and 116 were open donor nephrectomies. The reasons for performing open donor nephrectomy in 116 cases were: administrative circumstances (only two surgeons performing laparoscopic donor nephrectomy), right-hand side chosen (several arteries on left-hand side, differences in kidney size) and extensive previous abdominal surgery. Obesity was not considered a contraindication. Almost all the donors that were not included, even though the inclusion criteria were fulfilled, were rejected because of practical and administrative reasons. Fewer than five eligible donors were rejected for other reasons. A total of 122 living kidney donors were randomized and informed about the result at admission to hospital, 1 4 days prior to the elective procedure. Only one patient opted out and was excluded from the study after having been randomized to open donor nephrectomy. The attitude of the Norwegian population regarding laparoscopic versus open surgery was, and still is, quite balanced, and the donors were informed that there was no hard evidence in favor of either procedure, according to the Australian meta-analysis (16). Due to a prolonged inclusion period, the donors were randomized in blocks of 20. The study protocol was approved by The Regional Ethics Committee. Surgical techniques The nephrectomies were performed at Rikshospitalet University Hospital from February 2001 to May The surgical techniques have been described previously (17). In summary, all laparoscopic donor nephrectomies were performed in the flank position, with pneumoperitoneum at 9 11 mmhg, transperitoneal access through 4 5 ports and dissection mainly by means of a 5-mm ultrasonic knife. The first 23 laparoscopic donor nephrectomies were completed by conventional technique using a basket for kidney extraction through a midline infraumbilical incision. The last 39 laparoscopic donor nephrectomies were completed by employing a modified, simple hand-assisted technique (18). During the final stages, the left hand was introduced through a minimal incision (infraumbilical; without handport), to facilitate the handling and evacuation of the free kidney. Only a long left glove was needed for this modification. The required incision was of the same length as needed for basket extraction. The open donor nephrectomies were performed by conventional retroperitoneal access through flank incision at the level of costa and without rib resection. The length of the skin incision varied from 12 to 18 cm. Two different surgeons performed the laparoscopic nephrectomies, one with extensive and one with moderate laparoscopic experience. The latter was responsible for all the hand-assisted procedures. Six different surgeons, all experienced transplant surgeons, performed the open donor nephrectomies. Pre- and postoperative analgesia All donors received anesthesia and postoperative pain management guided by the same standardized protocol. A pilot study had been conducted prior to the study to assess the feasibility and analgesic efficiency of a common standardized anesthetic and analgesic regime. Following satisfactory results, this new regimen was established for all study patients. At the start of the donor operation 8 mg dexamethason was administered intravenously as a single dose, while intravenous pro-paracetemol and ketorolac were started at the end of anesthesia. On the day of surgery and on postoperative day 1 and 2, the donors received pro-paracetamol 2 g 4 and ketorolac 30 mg 3 intravenously, thereafter oral medication; paracetamol 1g 4 and ketorolac 10 mg 4. For the first postoperative days, a patientcontrolled analgesic pump (PCA) delivered intravenous opioid pain relief (ketobemidon) in bolus doses of 0, 1 mg/kg body weight, each dose trigged by patient s action. According to unit policy, the PCA was discontinued when the patients felt ready to step down to enteral analgesics, whereafter oral ketorolac were offered, supplemented by intravenous opioids as needed. Data collection Postoperative opioid requirement: The amount of ketobemidon administered on the day of surgery and the two following postoperative days was obtained from medical charts and reported as units of parenteral morphine equivalents (mg). Time on PCA was recorded as number of days of use. Postoperative pain on second postoperative day: Standardized bedside patient interviews were performed by two trained researchers to register self-reported pain on the second postoperative day when the donors usually ambulate to out-of-bed activities generally trigging wound pain. We used a 10-cm horizontal Visual Analog Scale (VAS) to measure pain intensity at rest and during a standardized cough and deep breath exercise. Patients were asked to draw a vertical line through the scale at a point representing the level of pain intensity, anchored on the left with words signifying no pain (=0), and on the right-hand side with word signifying the worst imaginable pain (=10). The VAS has previously been validated (19) and applied for the comparison of pain outcome following laparoscopic and open donor nephrectomy (20). Postoperative pain 1 month after surgery: Pain data at 1 month post donation were collected by self-administered questionnaires mailed to the patients. The patients were asked whether or not they had experienced pain related to donor surgery during the last 24 h. Those answering yes were asked to rate their pain intensity by using a numeric rating scale (NRS) with 0 indicating no pain and 10 indicating the most imaginable pain. The patients were also asked whether or not they had taken any oral analgesic drugs related to donor surgery during the last 24 h, and during the last week. Sick leave: Data on sick leave were collected at approximately 1 year post donation by telephonic interviews. The donors were asked: (For how many weeks after hospital discharge were you on sick leave?) Sick leave was calculated from the first week after discharge from hospital. Demographic variables: Socio-demographic variables including age, gender, type of work (physically or not physically demanding work), and relation to the recipient were obtained from the donors medical charts (Table 1). Data analysis Analysis was based on intention-to-treat. Accordingly, one patient converted from laparoscopic to open surgery was classified in the laparoscopic group. The primary end points of the study were postoperative analgesic requirements, self-reported postoperative pain and duration of sick leave. Power analysis revealed that 35 patients in each group would be required to detect 4-week postoperative pain differences found in previous studies (4), using a power of 80% and a level of statistical significance of 5%. To provide adequate power for additional analysis we planned to enrol 55 patients in each group with further allowance for 10% loss of respondents during follow-up. Differences between the two treatment groups were analyzed with v 2 statistics and Fisher s exact test for categorical data. Continuous variables were analyzed with an independent sample Student s t-test. Regarding the comparison of duration of sick leave between the groups, two patients suffering from chronic backache were excluded from data analyses. We used multiple linear regression analysis to test the effects of surgical technique on duration of sick leave, adjusting for donor recipient relationship and patients socio-demographic characteristics. A p-value of less than 0.05 was considered statistically significant. The SPSS statistical package version 12.0 (SPSS, Chicago, Illinois) was used for all statistical analyses. American Journal of Transplantation 2006; 6:

3 Andersen et al. Results All 122 donors underwent surgery according to the randomization. Follow-up at 1month was completed for 120 donors. Preoperative characteristics: A total of 55 men and 67 women participated in the study. Baseline characteristics were well-balanced across the randomized groups. Protocol violations: There were minor violations of the analgesic protocol: three patients did not receive dexamethason and intraoperative ketorolac was not administered to nine patients. In 33 patients one or two of the intravenous doses of proparacetamol were replaced by oral paracetamol, while eight patients received an oral dose of ketoralac instead of intravenous medication. Discontinuation of ketorolac occurred in two patients due to side effects. Supplemental medication included petidinhydrochloride (three patients), tramadolhydrochloride and codeinphosphate/paracetamol (one patient) and additional oral ketobemidonhydrochloride (one patient). Pre- and postoperative course: The mean operative time was approximately 40 min shorter in the open group compared to the laparoscopic group (140 min vs. 180 min). Mean operative time for the last 20 laparoscopic procedures was 175 min. Five major postoperative complications resulting in reoperations occurred in the laparoscopic group. These were caused by moderate bleeding from a port site (1), a forgotten sponge in the infraumbilical incision (1), jejunal perforation (2) and incarceration of bowel in a port site (1). In the open group there were no major complications. For a complete description of pre- and postoperative complications, the reader is referred to Øyen et al. (17). There was no significant difference in hospital stay among the two groups; 6,2 postoperative days in the laparoscopic group versus 6,7 days in the open group. However, data on length of hospitalization is not informative, as the established clinical tradition at our center has been to allow donors to remain in-patients for about 1 week to follow their recipients. Table 1: Donor characteristics at baseline Laparoscopic Open surgery surgery p-value N (%) 63 (51.6) 59 (48.4) Age; mean (SD) 46 (11.1) 45 (11.4) a Male gender; N (%) 29 (46.0) 26 (44.1) b BMI (kg/ m 2 ); mean (SD) 25.4 (3.0) 25.7 (3.4) a Donor is related to 51 (81.0) 46 (78.0) b recipient; N (%) Parental donors; N(%) 8 (12.7) 11 (18.6) b Employed; N(%) 53 (84.1) 45 (76.3) b Values are given as mean (SD) or as counts (%). a Student s t-test. b Fisher s exact test. Table 2: Postoperative opioid analgesic requirement and selfreported pain during hospital recovery, according to treatment groups Laparoscopy Open N (L) surgery (O) (L/O) p-value Units of parenteral morphine equivalents (mg) Day of surgery 14.5 (8.7) 18.6 (9.9) 63/ a First postoperative 16.9 (12.5) 19.5 (13.5) 63/ a day Second postoperative day 12.1 (10.4) 14.0 (14.7) 63/ a Pain scores on VAS at second postoperative day VAS at rest 1.0 (1.2) 1.1 (1.4) 57/ a VAS in motion 2.6 (2.3) 2.5 (1.7) 57/ a Values are given as mean (SD) or as counts. a Student s t-test. Postoperative opioid analgesic: As presented in Table 2 the amount of opioid analgesics administered was only moderate in both groups and less in patients going through laparoscopic nephrectomy. The difference between groups was only statistically significant on the day of surgery. There was no difference between the two groups regarding time on PCA. Postoperative pain on second postoperative day: According to the VAS assessments on the second postoperative day, pain intensity was low and there were no differences between the two groups (Table 2). Convalescence: One month post donation, selfreported pain was significantly in favor of laparoscopy (Table 3; p = 0.015). Furthermore, there was a significant difference between the groups regarding mean NRS scores 1 month after surgery (p = 0.002) and regarding pain medication during the last 24 h (p = 0.048). Donors undergoing laparoscopic surgery returned to work sooner than patients undergoing open surgery (p = 0.010). Multiple regression analysis revealed that also after adjusting for the effects of socio-demographic variables and donor recipient relationship, the effect of surgical technique on duration of sick leave remained significant (Table 4). In addition, we found an independent effect of the donor recipient relationship: donors being a parent to the recipient had a longer duration of sick leave compared to donors not being parents. Discussion The donors in our study were given less parenteral analgesic and reported less pain than indicated in previous studies, using the same measures (1,2). Parenteral analgesic requirements in favor of laparoscopic surgery have been reported in several retrospective studies comparing laparoscopic and open donor surgery (3,4,6,13,21 24). We thus conclude that the intravenous 1440 American Journal of Transplantation 2006; 6:

4 Outcomes in Laparoscopic Versus Open Donor Nephrectomy Table 3: Self-reported pain related to donor surgery at 1 month post donation and duration of sick leave Open Laparoscopy surgery N p-value No pain 40 (63.5%) 24 (42.1%) 63/ a NRS; pain mean (SD) 1.2 (2.0) 2.5 (2.4) 63/ b No use of pain 55 (88.7%) 43 (75.4%) 62/ a medication last 24 hours No use of pain medication the last week 56 (88.9%) 45 (78.9%) 63/ a Duration of sick leave (weeks) 7.1 (1.83) 9.5 (6.25) 51/ b a Fisher s exact test. b Student s t-test. Values are given as counts (%) or as mean (SD). Table 4: Multiple regression analysis: The effect of surgical technique on duration of sick leave (N = 51/42), adjusted for sociodemographic variables and donor recipient relationship B Variables (95% CI) p-value Gender (women) 1.80 (0.05; 3.54) Age 0.08 ( 0.02; 0.17) Donor recipient 3.05 (0.74; 5.36) relationship (parental or not parental donor) Type of work (physically or 1.50 (0.30; 3.29) not physically demanding) Type of surgery (laparoscopy or open) 2.32 (0.55; 4.10) B = unstandardized coefficients. CI = confidence interval for B. pain regimen, developed for our study, has demonstrated excellent pain management, probably reducing the patients pain intensity to a minimum level. However, this regimen may have disguised an actual difference in pain stimulation between the two groups during the first postoperative days. Less postoperative pain after laparoscopic surgery might have been reported with a traditional analgesic regimen, as shown in previous reports (3 5). As described in our previous paper (17) there were five reoperations in the laparoscopic group. One case was reoperated laparoscopically on day 1. The other four cases were reoperated by open midline incision between day 2 and day 10. All the reoperation cases in our study have been included in the pain and analgesia analyses in an intention-to-treat fashion. When protocol violations, reoperations and convertions were subtraced, the results regarding analgesic requirement and pain intensity remained unchanged. Since the transabdominal approach may have an increased incidence of complications, including small bowel obstruction and visceral injuries, we have switched to the modified laparoscopic/retroperitoneal approach at our center. Our results at 1 month post donation demonstrate that the laparoscopic group differed significantly from the open group regarding postoperative pain and duration of sick leave, also after taking patient background characteristics into account. Chronic back pain was present pre-donation in the two patients. Our data showed that the intensity of chronic back pain remained the same after donation. Several studies, comparing laparoscopic and open donor nephrectomy, have reported similar outcomes (3,4,8,14,21,25). It is reasonable to believe that the consequences of a laparoscopic approach, such as minimal tissue damage and a small incision for kidney extraction, explain the more rapid convalescence and quicker return to work compared to the traditional open approach. However, our patients, both in the laparoscopic and the open group, report longer duration of sick leave compared to what is reported in international studies. This may be explained by socioeconomic differences, and in particular the economic and social profile of the Norwegian society. The Norwegian social security system fully covers income loss during sick leave, and the financial incentive to resume work as quick as possible is consequently reduced. Furthermore, when the Norwegian donors are discharged from hospital they are routinely given a sick leave lasting for 6 weeks and few donors defy the prescribed recovery time. Multiple regression analysis indicated that parental donors had a significant longer duration of sick leave compared to donors not being parents to the recipients. Being a convalescent donor and caring for the recipient and other children in the family can be a very stressful combination. It is reasonable to believe that situations like this may result in prolonged sick leave for parental donors. Women had significant longer sick leave than men, possibly due to caring for the recipient and having several responsibilities at home during the convalescence. The consistency of our data is supported by the sample size and controlled design. It is the largest randomized study so far. All study patients were recruited from a single national center handling all transplant procedures. During the inclusion period there were few refusals and only two laparoscopic nephrectomies were performed outside the study. The amount of missing data at 1-month follow-up was less than 2%. Some limitations of our study should be acknowledged. First, two alternative technical approaches to laparoscopic nephrectomy were used. The first part of the series was performed as standard laparoscopic nephrectomies, whereas in the last part a modified, hand-assisted technique was employed in order to shorten operative and warm ischemia time and at the same time increase safety (17,25,26). However, the midline, infraumbilical incision, 6 9 cm, and the extent of dissection inside the abdominal American Journal of Transplantation 2006; 6:

5 Andersen et al. cavity were exactly the same with the two laparoscopic approaches. We therefore believe that the consequences of the different laparoscopic approaches were insignificant regarding postoperative pain medication, self-reported pain and convalescence. Earlier reports support this assumption (27,28). On this background we classified the patients into only two groups: the laparoscopic and the open group. Another limitation may be that only two surgeons performed all the laparoscopic nephrectomies, one with extensive laparoscopic experience and one with less extensive experience, while six surgeons performed the open nephrectomies. However, these six were all consultant transplant surgeons very well-skilled in the common open procedure and adherent to the standardized guidelines of a single center. Finally, this study was not blinded. The donors, their relatives, and the health-care personnel were possibly affected in the way they respectively responded by knowledge of which surgical method the donors underwent. This could have an impact on the donors assessments, for instance on their pain ratings. In conclusion, the donors in the laparoscopic group clearly benefited from a more complete convalescence in terms of a shorter sick leave period compared with patients in the open group. Our study showed that immediate postoperative pain can be managed efficiently regardless of procedure. However, a lower consumption of opioids and less pain in the convalescent period suggest a clinically relevant patient-experienced benefit from a successful laparoscopic approach. Also, this may reduce the risk of long-lasting pain post donation. Acknowledgments The authors are grateful to Geir Aamodt, Ph.D. and Marijke Veenstra Ph.D. for statistical advice and Trond Andrè Aag for data support. The patients generously shared their experiences and made this study possible. This study is funded with the aid of Southern Norway Regional Health Authority, The Norwegian Nurses Association, The Department of Surgery and The Centre of Patient Participation and Nursing Research at Rikshospitalet- Radiumhospitalet University Hospital, Norway. References 1. Steinhauser MM, Dawson PB, Barshick RM, Janecek JL. Pain experienced by laparoscopic donor nephrectomy patients in an academic medical setting. Prog Transplant 2003; 13: Freedland SJ, Blanco-Yarosh M, Sun JC et al. Ketorolac-based analgesia improves outcomes for living kidney donors. Transplantation 2002; 73: Lennerling A, Blohme I, Ostraat O, Lonroth H, Olausson M, Nyberg G. Laparoscopic or open surgery for living donor nephrectomy. Nephrol Dial Transplant 2001; 16: Perry KT, Freedland SJ, Hu JC et al. 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6 Outcomes in Laparoscopic Versus Open Donor Nephrectomy 25. Sundquist P, Feuk U, Häggman M, Persson AEG, Stridsberg M, Wadstrøm J. Hand-assisted retroperitoneoscopic live donor nephrectomy in comparison to open and laparoscopic procedures: A prospective study on donor morbidity and kidney function. Transplantation 2004; 78: Lindstrøm P, Haggman M, Wadstrom J. Hand-assisted laparoscopic surgery (HALS) for live donor nephrectomy is more timeand cost-effective than standard laparoscopic nephrectomy. Surg Endosc 2002; 16: Slakely DP, Wood JC, Hender D, Thomas R, Cheng S. Laparoscopic living donor nephrectomy: Advantages of the handassisted method. Transplantation 1999; 68: Wolf JS, Moon TD, Nakada SY. Hand-assisted laparoscopic nephrectomy: Comparison to standard laparoscopic nephrectomy. J Urol 1998; 160: American Journal of Transplantation 2006; 6: