PAPER. Quantification of Pain and Satisfaction Following Laparoscopic and Open Hernia Repair

Transcription

1 AER Quantification of ain and Satisfaction Following and Hernia Fumihiko Fujita, MD; Brian Lahmann, MD; Koji Otsuka, MD; Sergey Lyass, MD; Jonathan R. Hiatt, MD; Edward H. hillips, MD Hypothesis: Subjective experiences can be quantified by visual analog scale (VAS) scoring to improve comparison of surgical techniques. Design: rospective collection of outcome data by interview of patients at 1 day and 1 week following nonrandomized elective hernia repair by a single surgical group between May 1998 and April Setting: Cedars-Sinai Medical Center, Los Angeles, Calif. atients: A total of 253 patients (239 men; mean age, 59 years) underwent repair by laparoscopic (n=110, 105 bilateral, 92 total extraperitoneal, and 18 transabdominal preperitoneal) or tension-free open (n=143, 133 unilateral) approach. patients were significantly younger (52.0 vs 63.8 years,.001). Main Outcome Measures: Subjective measures included VAS scores (1-10, 1 indicates best) for pain at 1 day and 1 week postoperatively and overall satisfaction at 1 week. Objective measures included quantity and days of analgesic use and days before return to regular activities, including work and driving. Results were also compared by patient age (Spearman analysis). Results: Satisfaction was high for both procedures; the laparoscopic procedure was superior only for return to work and driving. Spearman analysis showed a significant inverse relation between age and first-day pain (r= 0.15, =.01), independent of operative approach. Because laparoscopic patients were younger, patients younger than 65 years were analyzed separately; laparoscopic patients had significantly less first-day pain (5.44 vs 6.30, =.02). Conclusions: ain following hernia repair was age dependent. Following laparoscopic repair, patients had lower first-day pain scores in younger patients and earlier return to normal activities in all patients. Satisfaction was similar for both approaches. Subjective experiences can be quantified, compared to detect subtle differences in outcome for competing surgical techniques, and used to counsel patients before operation, with the goal of improving satisfaction. Arch Surg. 2004;139: From the Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, Calif. SURGERY HAS BEEN TRANSformed in the last decade not only by technology but also by efforts to make surgical decision making evidence based. Sophisticated outcome measures are designed to help patients and payers discriminate among procedures, practitioners, and hospitals. Crude measures, including 30-day morbidity and mortality, no longer are sufficient; patients demand quality-of-life measures, whereas payers expect satisfaction data as well. These changes preceded but were accelerated by the laparoscopic revolution, which promised less pain, improved cosmesis, and shorter disability, often without compelling randomized trials. Outcome measures are particularly important for common procedures, such as herniorrhaphy. In inguinal herniorrhaphy, major complications and mortality are so infrequent that most studies cannot attain sufficient power to discern among treatment groups. Since the widespread adoption of mesh in primary hernia repair, recurrence has decreased from approximately 10% to approximately 1%. This has been documented by evidencebased studies that show a significant reduction in recurrence without an increase in complications, infection, pain, or disability. 1 ain has been quantified by a variety of instruments, including verbal rating scales, plain numerical scales, and the visual analog scale (VAS). Our VAS uses various expressive faces to quantify pain and has been shown to be a reliable and linear tool for assessing mild-to-severe postoperative pain

2 A OD 1 B OD atients, % Figure 1. Visual analog scale (VAS) scores for patients undergoing laparoscopic and open repairs on postoperative days (ODs) 1 (A) and 7 (B). The present study was undertaken to test the hypothesis that VAS scoring can be used to quantify patients subjective experiences of pain and satisfaction. Such quantification may help to identify small differences among competing operative techniques. METHODS All patients undergoing elective mesh groin hernia repair by a single surgical group at Cedars-Sinai Medical Center, Los Angeles, Calif, between May 1998 and April 2003 were entered into this study. The type of repair was chosen by the surgeon in consultation with the patient. repair with the patient under local anesthesia was recommended for unilateral hernias and for patients at increased risk of complications while under general anesthesia. atients with bilateral or recurrent hernias were offered laparoscopic repair, unless there was a giant scrotal hernia or a history of extensive lower abdominal or preperitoneal operation. repair was also performed in good-risk patients with unilateral hernias who requested this approach. repair was performed using tensionfree Lichtenstein 5 or mesh plug 6 techniques. repair was performed using predominantly the total extraperitoneal or occasionally transabdominal preperitoneal approaches. 7,8 Datawerecompiledconcurrentlyforeachpatientandincluded age, sex, unilateral vs bilateral hernia, operative approach, operative time, and complications. All patients were seen on the seventhpostoperativeday, atwhichtimetheycompletedanindividual questionnaire administered by the operating surgeon. Subjective and objective data were collected from this questionnaire. Subjective data included satisfaction and pain. atients were asked to rate (1) overall satisfaction with the operative experience on the seventh postoperative day and (2) postoperative pain on the first and seventh days. The rating tool was a VAS score with a range of 1 (best score) to 10 (worst score) 2-4 ; patients were asked to identify the facial expression that represented their subjective experience (Figure 1), and the corresponding number was then recorded. Objective data included (1) quantity and duration of analgesic use and (2) the number of postoperative days before returning to regular activities in which the patients had engaged before operation. These activities included driving, work, and athletics; patients were instructed to return to these activities when they felt comfortable doing so. They were instructed not to drive or operate machinery while they were taking narcotic pain medication. Analyses were performed using Graphad rism version 3.02 (Graphad Software Inc, San Diego, Calif). Continuous variables were compared with the 2-tailed, paired t test, and categorical variables were compared with Fisher exact test or 2 analysis. Spearman rank order correlation was used to analyze a relationship between postoperative pain and age. Statistical significance was accepted at the.05 level. RESULTS During the study period, 300 patients underwent inguinal herniorrhaphy with mesh. Of these, 47 were excluded because of incomplete questionnaires. Consequently, 253 patients, 110 who underwent laparoscopic repair and 143 who underwent open repair, were compared in this analysis. Average age was 58.6 years (range, years), and 239 (95%) were male. The demographics of the 47 excluded patients were similar to those included in the study. ERIOERATIVE DATA atients undergoing laparoscopic repair were younger and more frequently male. Bilateral hernias were far more common in the laparoscopic group. All laparoscopic repairs required general anesthesia, whereas most open repairs were performed with the patient under local anesthesia. The principal operative technique was total extraperitoneal repair in the laparoscopic group and Lichtenstein repair in the open group. Operative times were significantly longer for laparoscopic repairs (Table 1). There were no major complications. Although the difference did not achieve significance, minor complications were more common in the laparoscopic group and included wound problems in 10 (infection, hematoma, or seroma), urinary retention in 4, and others (non hernia-related complaints, such as dizziness, hemorrhoids, and constipation) in 5. Complications in the open repair group included wound problems in 12 and urinary retention in 1. Data regarding postoperative hospital admission were available for 223 of the 253 patients. Following laparo- 597

3 Table 1. erioperative Data* (n = 110) scopic repair, 8 patients (8%) were admitted, as were 13 patients (10%) following open repair. OUTCOME DATA (n = 143) Age, mean ± SD, y 52.0 ± ± Sex Male 109 (99) 130 (91) Female 1 (1) 13 (9).004 Hernia repair Unilateral 5 (5) 133 (93) Bilateral 105 (95) 10 (7).001 Anesthesia General 110 (100) 10 (7) Local (89).001 Spinal 0 6 (4) Technique Total extraperitoneal 92 (84) 0 Transabdominal preperitoneal 18 (16) 0 Lichtenstein (88) Mesh plug 0 17 (12) Operative time, min Minor complications 19 (17) 13 (9).06 *Data are given as number (percentage) of patients except where indicated. Table 2. Outcome Data for All atients* (n = 110) (n = 143) Overall satisfaction 1.54 ± ± ain ostoperative day ± ± ostoperative day ± ± value Analgesia No. of tablets 9.69 ± ± No. of days taken 2.96 ± ± Return to activities Driving No. of patients No. of days 4.41 ± ± Work No. of patients No. of days 8.73 ± ± *Data are given as mean ± SD except where indicated. Overall satisfaction was similarly high for both laparoscopic and open procedures. ain scores decreased significantly from the first to the seventh postoperative day, but there were no differences between groups (Table 2). ain scores are shown in Figure 1; the distribution of scores was broad at 1 day and much narrower at 1 week following operation. Analgesic requirements, both quantity and duration, were similar for both groups. Following the laparoscopic procedure when compared with open Age, y Figure 2. Visual analog scale (VAS) scores on postoperative day 1 by patient age. Table 3. Outcome Data for atients Younger Than 65 Years* (n = 99) repair, patients returned earlier to driving and work but not athletics. ANALYSIS BY AGE (n = 63) Age, y 50.0 ± ± Visual analog scale score Overall satisfaction 1.5 ± ± ain ostoperative day ± ± ostoperative day ± ± value Analgesia No. of tablets 9.64 ± ± No. of days taken 2.87 ± ± Return to activities Driving No. of patients No. of days 5.05 ± ± Athletics No. of patients No. of days 9.19 ± ± *Data are given as mean ± SD except where indicated. When data were analyzed using Spearman rank order correlation (Figure 2), there was a significant inverse relation between age and pain score on the first postoperative day (r= 0.15, =.02), with younger patients having higher overall scores. Although statistically significant, age accounts for only a small amount (2%) of the variability in first-day pain. Because patients undergoing laparoscopic repair were significantly younger than those who underwent open repair, outcome data were also analyzed for patients younger than 65 years (Table 3). In contrast to the entire series, younger patients who underwent laparoscopic repair had lower pain scores on the first postoperative day when compared with younger patients who underwent open repairs. However, there was no difference by the seventh postoperative day. 598

4 COMMENT In a recent bulletin of the American College of Surgeons, Executive Director Thomas Russell wrote that the surgeon of the future will...need to be aware of accurate outcomes data that demonstrate the short-and long-term effects of operative procedures...and share this information not only with... patients, but with payers... credentialing and privileging bodies... 9 In that spirit, we and other investigators have undertaken to document outcome measures for groin hernia repairs, of which are performed annually. 10 Our data show that patient satisfaction and subjective pain can be quantitated and that these are similar for laparoscopic and tension-free open hernia repair when performed in selected patients. Satisfaction was high for both procedures. ain scores decreased significantly from the first to seventh postoperative day. After laparoscopic repair, patients returned earlier to work and driving. atients younger than 65 years experienced more pain than those 65 years and older. Younger patients had less pain with laparoscopic than with open repair, even though most underwent bilateral laparoscopic herniorrhaphies. The number of days before returning to work and driving was significantly shorter in the laparoscopic group, but the laparoscopic patients were younger, and socioeconomic factors, which have been shown to influence return to work, were not studied. The age difference may also have affected the time to return to driving, which was shorter in the laparoscopic patients. However, when patients younger than 65 years were analyzed separately, there was no difference in return to driving. Overall satisfaction, which reflects the entire operative and perioperative experience, is of great importance but difficult to quantitate. Satisfaction is most often measured by adjectives ( very satisfied, moderately satisfied, or dissatisfied ); these terms have been used to compare satisfaction data for laparoscopic vs open hernia repair Our data were collected by showing the patients a VAS and asking them to point to a face that corresponds with their level of satisfaction with the procedure. The patients readily identify the appropriate face, requiring less reasoning and rationalizing than a numerical scale. Many factors affect pain, including type of operation, complications, age, tolerance, and cultural issues. Different anesthetic techniques also may affect postoperative pain. In our series, all patients in the laparoscopic group had general anesthesia, whereas most patients in the open group had local anesthesia. Of note, a randomized trial that compared local with general anesthesia in open hernia repair showed no difference in postoperative pain or recovery. 14 Our series is the second to demonstrate that early postoperative pain is age dependent. Callesen et al 15 showed a negative correlation between age and pain while moving and coughing during the first postoperative week. Bay-Nielsen et al 16 suggested that older patients had a lower incidence of chronic pain. In some reports, patients with inguinal hernia treated by a laparoscopic procedure had less postoperative pain than those treated by an open procedure. 11,12,17-19 Several authors have demonstrated this difference in the first postoperative week, 12,19 but various measures of pain have been used, making it difficult to compare different series. Studies that compare pain response after laparoscopic repair and open hernioplasty 16-18,20-23 have used verbal scales (mild, moderate, severe), simple rating scores (eg, 1-10), and the 100-mm VAS scores. In 14 prospective randomized trials that specifically assessed pain, 6 different measuring devices were used. Callesen et al 15 used a 4-point verbal rank scale (none, slight, moderate, or severe pain). Wellwood et al 11 used a simple integer score, ranging from 1 to 10. Others used questionnaires with descriptive terms 16 or the absolute presence or absence of pain. 19 Four studies 18,21-23 used a VAS with scores ranging from 0 to 100, asking the patient to rate the pain level along a 10-cm line. Six studies 12,13,17,20,24,25 used a VAS that ranges from either 0 to 10 or 1 to 10. The VAS score is superior because of its documented reliability and validity. It has been proven to be a linear scale for quantifying pain and to be accurate for serial measurements. 2,3 Additionally, the absolute values of VAS measurements are clinically relevant. Carlsson 26 found that the posttreatment pain score was more accurate in assessing interventional success than calculated reduction in scores for an individual patient. Also, several authors have found clinical relevance in grouping VAS scores. Most agree that VAS scores from 0 to 3 correspond to mild pain, for which patients do not seek analgesia. Scores from 4 to 6 represent moderate pain and 7 to 10 severe pain. When analyzing data in these broad categories, it is possible to identify clinically significant differences between treatment groups. In the moderate or severe ranges, several studies 3,27,28 show clinical significance if the difference in pain score is at least 0.9 or 1.3 between groups. Several investigators have used pain assessment by VAS to compare hernia techniques. 12,13,17,20,24,25 The pain scores on postoperative day 1 ranged from 1.8 to 5.4 for laparoscopic repairs and 2.2 to 5.7 for open repairs. The variability of scores emphasizes the uniqueness of patient populations, but the differences in scores between techniques in each study were similar: 0.3 to 1.9 (postoperative day 1) and 0.1 to 1.5 (day 7). The difference in pain scores on the first postoperative day between laparoscopic and open technique in our patients younger than 65 years was 0.9 and was statistically significant. Calculated difference in scores is a useful comparative tool, using VAS for baseline scoring, because VAS is a simple and uniformly accepted method to assess pain and is used in most hospitals. Our results cannot be used to prove the superiority of one technique over another. Our data were not randomized, and patients in the different groups were not matched for age, bilaterality, or method of anesthesia. Moreover, data were collected by the surgeon, to whom the patient might not choose to complain. However, the data show that subjective experiences following surgery can be quantified, allowing individual surgeons to counsel patients regarding realistic expectations in the postoperative period. VAS should be used in other investigations as an outcome measure, because it is universal, reliable, and easily understood by every reader. 599

5 Accepted for publication February 6, This paper was presented at the Annual Meeting of the Western Surgical Association; November 12, 2003; Tucson, Ariz; and is published after peer review and revision. The discussions that follow this article are based on the originally submitted manuscript and not the revised manuscripts. Corresponding author and reprints: Edward H. hillips, MD, Department of Surgery, Cedars-Sinai Medical Center, 8635 W Third St, 795 W, Los Angeles, CA ( edward.phillips@cshs.org). REFERENCES 1. Voyles CR. Outcomes analysis for groin hernia repairs. Surg Clin N Am. 2003; 83: Myles S, Troedel S, Boquest M, Reeves M. The pain visual analog scale: is it linear or nonlinear? Anesth Analg. 1999;89: Bodian CA, Freedman G, Hossain S, Eisenkaft JB, Beilin Y. The visual analog scale for pain: clinical significance in postoperative patients. Anesthesiology. 2001; 95: Ohnhaus EE, Adler R. Methodological problems in the measurement of pain: a comparison between the verbal rating scale and the visual analog scale. ain. 1975;1: Lichtenstein IL, Shulman AG, Amid K, Montllor MM. The tension-free hernioplasty. Am J Surg. 1989;157: Millikan KW, Cummings B, Doolas A. The Millikan modified mesh-plug hernioplasty. Arch Surg. 2003;138: Maddern GJ. Transabdominal preperitoneal inguinal hernioplasty. In: Maddern GJ, Hiatt JR, hillips EH, eds. Hernia : Versus Approaches. New York, NY: Churchill Livingstone; Friedman RL, hillips EH. ally-guided total extraperitoneal inguinal hernioplasty. In: Maddern GJ, Hiatt JR, hillips EH, eds. Hernia : Versus Approaches. New York, NY: Churchill Livingstone; Russell TR. What is the future of surgery? Arch Surg. 2003;138: Rutkow IM. Demographic and socioeconomic aspects of hernia repair in the United States in SurgClinNAm. 2003;83: Wellwood J, Sculpher MJ, Stoker D, et al. Randomised controlled trial of laparoscopic versus open mesh repair for inguinal hernia: outcome and cost. BMJ. 1998;317: Lal, Kajla RK, Chander J, Saha R, Rametke VK. Randomized controlled study of laparoscopic total extraperitoneal versus open Lichtenstein inguinal hernia repair. Surg Endosc. 2003;17: Heikkinen TJ, Haukipuro K, Koivukangas, Hulkko A. A prospective randomized outcome and cost comparison of totally extraperitoneal endoscopic hernioplasty versus Lichtenstein hernia operation among employed patients. Surg Laparosc Endosc. 1998;8: O Dwyer J, Serpell MG, Millar K, et al. Local or general anesthesia for open hernia repair: a randomized trial. Ann Surg. 2003;237: Callesen T, Bech K, Nielsen R, et al. ain after groin hernia repair. Br J Surg. 1998;85: Bay-Nielsen M, erkins FM, Kehlet H. ain and functional impairment 1 year after inguinal herniorrhaphy: a nationwide questionnaire study. Ann Surg. 2001; 233: Stoker DL, Spiegelhalter DJ, Singh R, Wellwood JM. versus open inguinal hernia repair: randomised prospective trial. Lancet. 1994;343: Liem MS, van der Graaf Y, van Steensel CJ, et al. Comparison of conventional anterior surgery and laparoscopic surgery for inguinal-hernia repair. N Engl J Med. 1997;336: Group TMLGHT. versus open repair of groin hernia: a randomised comparison. Lancet. 1999;354: Bringman S, Ramel S, Heikkinen TJ, Englund T, Westman B, Anderberg B. Tensionfree inguinal hernia repair: TE versus mesh-plug versus Lichtenstein: a prospective randomized controlled trial. Ann Surg. 2003;237: Lawrence K, McWhinnie D, Goodwin A, et al. Randomised controlled trial of laparoscopic versus open repair of inguinal hernia: early results. BMJ. 1995;311: age B, aterson C, Young D, O Dwyer J. ain from primary inguinal hernia and the effect of repair on pain. Br J Surg. 2002;89: Wright D, aterson C, Scott N, Hair A, O Dwyer J. Five-year followup of patients undergoing laparoscopic or open groin hernia repair: a randomized controlled trial. Ann Surg. 2002;235: Mahon D, Decadt B, Rhodes M. rospective randomized trial of laparoscopic (transabdominal preperitoneal) vs open (mesh) repair for bilateral and recurrent inguinal hernia. Surg Endosc. 2003;17: Colak T, Akca T, Kanik A, Aydin S. Randomized clinical trial comparing laparoscopic totally extraperitoneal approach with open mesh repair in inguinal hernia. Surg Laparosc Endosc ercutan Tech. 2003;13: Carlsson AM. Assessment of chronic pain, I: aspects of the reliability and validity of the visual analogue scale. ain. 1983;16: Kelly AM. Does the clinically significant difference in visual analog pain scores vary with gender, age, or cause of pain? Acad Emerg Med. 1998;5: Todd KH, Funk KG, Funk J, Bonacci R. Clinical significance of changes in pain severity. Ann Emerg Med. 1996;27: DISCUSSION Keith Millikan, MD, Chicago, Ill: This is a very timely study, since we are seeing, as mentioned yesterday, that the American College of Surgeons is actually going to start looking at laparoscopic vs open hernia repair. I m not sure that s the right thing to look at, but I will talk about that in a little bit. ain is something that is very hard to measure. I looked at the visual analog scoring system, the first thing that came to mind was when I was 16 years old and taking my driver s license test, they had changed all of the signs, the colors, the shapes so that people who were uneducated or couldn t read English basically could drive and it could be compared universally now to all countries rather than having language as a barrier. The second thing that came to mind was this weekend when my family was watching the new video release Disney movie when the fish was thought to be dead at the end of the movie, the two women in my family cried and the men didn t. Now you look at the scale, you have a smiley face on one side, you have crying on the other side and we have a population mainly of men within our hernia population, men usually don t feel it acceptable to cry so is that a good thing to look at in a hernia population that is in men? I m not sure it is. The object of this study was that we could look at subjective experiences and quantify them to improve comparison of techniques. They measured postoperative day No. 1 on postoperative day No. 7. Is that correct? Can someone actually quantify what their pain was a week later from postoperative day No. 1? They measured pain on postoperative day 7 and also measured satisfaction. I learned yesterday that satisfaction equaled being involved in a lawsuit or not where that wasn t mentioned in the manuscript. Is satisfaction for a procedure at 1 week or is it when the patient has chronic pain or recurrence at 1 or 2 years down the line? So I m not sure that we are actually measuring satisfaction of the procedure. Maybe expectations that the patient had preoperatively at 1 week. This generates several questions for the authors. (1) In your manuscript, although not depicted on the slides, 300 patients started out in this study, 47 were unable to complete the questionnaire, that is 16%, so why did the 16% have an incomplete questionnaire? Does this indicate that a significant portion of the population did not understand the VAS system? (2) Some patients come to the office with preoperative pain in hernias and others are totally asymptomatic other than a bulge. Should the patients be rated before surgery to obtain a baseline and to also find out if patients with preoperative pain are improved after the hernias are repaired? (3) As I said previously, can postoperative pain on day No. 1 be rated on day No. 7? (4) Is it fair to report return to work in a population which we are not told if they are blue-collar vs white-collar workers? We re told that one side of the coin was that they had an older population over 65 and another was a younger population. (5) Why are 115 out of the 253 or 45% of the patient population bilateral inguinal hernias? Is this not an abnormal hernia population bias and can we extend the VAS to a normal hernia population bias? 600