THE EFFECT OF ILIOINGUINAL-ILIOHYPOGASTRIC BLOCK WITH OR WITHOUT INTRA- VENOUS PARACETAMOL FOR PAIN RELIEF AFTER CAESAREAN DELIVERY

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1 Acta Medica Mediterranea, 2014, 30: 1183 THE EFFECT OF ILIOINGUINAL-ILIOHYPOGASTRIC BLOCK WITH OR WITHOUT INTRA- VENOUS PARACETAMOL FOR PAIN RELIEF AFTER CAESAREAN DELIVERY ALI PEKMEZCI 1, MEHMET CESUR 2, MEHMET AKSOY 3, ILKER INCE 3, AYSE NUR AKSOY 4 1 Department of Anaesthesiology and Reanimation, Iskenderun State Hospital, Hatay - 2 Department of Anaesthesiology and Reanimation, Faculty of Medicine, Gazıantep University, Gazıantep - 3 Department of Anaesthesiology and Reanimation, Faculty of Medicine, Ataturk University, Erzurum, Turkey - 4 Department of Obsterics and Gynaecology, Nenehatun Hospital, Erzurum, Turkey ABSTRACT Introduction and objective: ABSTRACT Aims: We aimed in this study to compare the postoperative analgesic efficacy of Ilioinguinal-Iliohypogastric (IHII) nerve block with or without intravenous (iv) paracetamol in patients undergoing caesarean section. Materials and methods: Ninety primiparous or multiparous women who had a single pregnancy and were scheduled for elective caesarean section under general anaesthesia were enrolled in the study. While patients in Group M (n=30) were given only Patient-controlled intravenous analgesia (PCIA) with morphine postoperatively, the patients in Group MB (n=30) were employed bilaterally IHII nerve block before extubation in addition to PCIA with morphine postoperatively. Patients in Group MBP (n=30), IHII nerve block before extubation and intravenous (IV) paracetamol were employed in addition to the PCIA with morphine postoperatively. Visual analogue scale scores (VAS), sedation scores, and status of satisfaction and morphine consumption of patients at 1 st, 4 th, 8 th, 12 th, 18 th and 24 th hours after the operation and morphine related side effects were recorded. Results: Postoperative cumulative morphine consumption (mg) for 24 hours was significantly higher in Group M (50.9 ± 11.7) than Group MB (36.2 ± 10.7) and Group MBP (16.4 ± 6.6), (p <0.001, for both). Patients in group M (n=23, %76) had a higher rate of nausea and vomiting compared to the patients in group MB (n=12, 41%) and group MBP (n=3, %11) (p<0.001, for both). Postoperative pruritus was observed more frequently among patients in group M (n=13, 43%) compared with group MB (n=6, 20%) and group MBP (n=5, 16%) (p<0.05, p=0.001; respectively). Conclusion: We conclude that the use of IHII nerve block with or without IV paracetamol reduces postoperative PCIA morphine consumption providing a safe and effective postoperative analgesia with good patient satisfaction. Also, this reduction is associated with a decrease in the incidence of morphine related side effects. Key words: General anaesthesia, caesarean section, IHII nerve block, paracetamol, postoperative morphine consumption. Received May 18, 2014; Accepted September 02, 2014 Introduction Caesarean section (CS) is a major intraabdominal surgery and postoperative pain is very significant. If this pain is not effectively resolved, it may cause undesirable outcomes such as delay in communication between a mother and her baby, delayed breastfeeding, prolonged hospitalization, pneumonia, deep vein thrombosis, pulmonary embolism, myocardial infarction, physiologic trauma, delay in improvement of bowel function, and urinary retention (1, 2). Regional anaesthetic techniques combined with opioids have been commonly used as an effective multimodal analgesic method for pain management after CS (3-5). Although regional anaesthesia is safer and more effective than general anaesthesia for pain management during and after CS, anaesthetists have to use general anaesthesia if regional anaesthesia is contraindicated (e.g. prior spinal surgery, coagulopathy and presence of infection at the injection site or patient refusal) (6). Patient-controlled intravenous analgesia (PCIA) with opioids (especially morphine) is widely used with high patient satisfaction for post-operative pain management of patients with caesarean

2 1184 Ali Pekmezci, Mehmet Cesur et Al section under general anaesthesia (7). However, depending on the dose of opioid used, opioid-related side-effects such as sedation, pruritus, nausea, vomiting and respiratory depression may occur. Multimodal analgesic methods have been investigated by researchers to minimize these undesirable side effects (8-10). The postoperative pain after CS has somatic and visceral components. While the area of incision is innervated by the iliohypogastric and ilioinguinal (IHII) nerves, the visceral component relating to peritoneal and visceral trauma is diffused without peripheral nerve association (1). We hypothesized that a combination of bilateral IHII nerve block for the somatic component of the pain and intravenous (IV) paracetamol for the visceral component would decrease postoperative morphine use and its undesirable side effects. We aimed in the present randomized, double-blind study to compare the postoperative analgesic efficacy of IHII nerve block with or without IV paracetamol in patients with CS under general anaesthesia. Materials and methods This prospective, randomized, controlled, double-blinded study was conducted over a year period at the Anaesthesia Department of Ataturk University, Medical Faculty, Erzurum, Turkey following ethics committee approval. Ninety American Society of Anaesthesiologist physical status I or II, between 20 and 40 years of age, primiparous or multiparous women who had a single pregnancy and were scheduled for elective caesarean section under general anaesthesia were enrolled in the study. Written informed consent was obtained from all patients before participation. Patients with a history of allergy to morphine, local anaesthetics of the amide groups or paracetamol, history of opioid use, hepatic or renal disease, preeclampsia and inability to use PCIA device were excluded from the study. Patients were randomly allocated into one of the three groups (n=30) after induction of general anaesthesia using a computer generated random number table. While patients in Group M (n=30) were given only PCIA with morphine postoperatively, the patients in Group MB (n=30) were employed bilateral IHII nerve block before extubation in addition to PCIA with morphine postoperatively. Patients in Group MBP (n=30) were employed IHII nerve block before extubation and iv paracetamol in addition to the PCIA with morphine postoperatively. Preoperatively, all patients were informed about the use of the PCA device. Ringer s lactate 500 ml IV bolus infusion was given for hydration and standard monitoring including non-invasive arterial pressure, electrocardiography and pulse oximetry was established in the operating room. Anaesthesia was induced with propofol 2 mg kg -1 and atracurium 0.5 mg kg -1. Tracheal intubation was performed and anaesthesia was maintained with nitrous oxide 50%, oxygen 50% and sevoflurane 1-2% at that the patients ventilatory parameters were set to maintain a goal end-tidal carbon dioxide between mmhg. CS was performed with Pfannenstiel skin incision and a low transverse uterine incision. After the baby was delivered and the umbilical cord was clamped, 5 units oxytocin and an antibiotic (ampicillin 1 g IV, if the patient is not allergic to the drug) were administered. The uterus was sutured without exteriorization and the parietal peritoneum was sutured with a single suture. Neuromuscular block was reversed with neostigmine 2.5 mg and atropine 0.9 mg. None of the patients were given opioids in the preoperative and intraoperative periods. During the operation, patients blood pressure, heart rate and oxygen saturation were monitored and recorded every 5 minutes. Immediately after surgery, patients in group M received PCIA with the following settings; loading morphine dose 3 mg IV, optional bolus dose 1 mg, lockout interval eight minutes, 4-hour limit of 18 mg without basal infusion. After stitching the incision and before extubation, the patients in group MB received bilaterally IHII nerve block. One of two experienced anaesthetists performed IHII nerve block for all patients using the method described by Huffnagle et al. (10) with minor modifications. A 22-gauge needle was inserted perpendicularly to the skin on a point 2 cm medial and 2 cm superior to the anterior superior iliac spine and advanced to the skin until characteristic click was detected on penetrating the fascia of the external oblique muscle. Advancing the needle further until a second characteristic click was felt as the needle penetrates the fascia of the internal oblique muscle. Following a negative aspiration test, 15 ml 0.5% bupivacaine was injected. The same procedure was repeated at the other side. Then the patients in group MB received PCIA with morphine as given to group M, although with-

3 The effect of ilioinguinal-iliohypogastric block with or without intravenous paracetamol out the bolus dose. The success of the block was assessed bilaterally with cold and tactile sensation. Patients without bilateral sensory loss were evaluated to have failed blocks and were withdrawn from the study. In group MBP as distinct from group MB, patients received İV paracetamol (1 g, every 6 hours for 24 hours) and the first dose of paracetamol was given immediately after the baby was born. Saline (100 ml) in a similar bottle of paracetamol was administered to the other two groups as a placebo. Assessment of the blocks and paracetamol application were performed by the attending anaesthesiologist (i.e., not a blinded independent observer). After then all assessment was performed by a blinded independent observer. After extubation, all patients were transferred to the recovery room. In the recovery room, an independent observer blinded to the group assignment recorded the following data at 1 st, 4 th, 8 th, 12 th, 18 th and 24 th hours after IHII nerve blocks: Visual analogue scale (VAS, 0 cm= no pain, 10 cm= worst pain imaginable) scores for pain severity at rest, sedation levels (0= wide awake, 1= sleepy but easily aroused, 2= sleepy and difficult to arouse, 3= unarousable) the total dose of morphine used after 24 hours, status of patient satisfaction (1= very dissatisfied, 2= dissatisfied, 3= satisfied, 4= very satisfied), whether pruritus (yes/no), respiratory depression (a rate below 12 breaths per minute), bradycardia (heart rate below 50 bpm), hypotension (as a drop of >20% below baseline mean arterial pressure) and nausea or vomiting (yes/no). Russ Lenth s Power and sample size calculation application was used for power analysis of this study (11). The primary end point of the study was to evaluate 30% decrease in morphine use among the groups at estimated time intervals postoperatively. 25 patients in each group were needed to detect the difference with a power of 90% at 5% significance level. Data were analysed using SPSS software 12.0 and calculated as mean±standard deviation, p<0.05 was considered significant. The Kolmogorov- Smirnov test was used to assess the normal distribution of data. If data was not normally distributed, comparisons were determined using Mann-Whitney U-test. Comparisons were determined using the Anova test when data was normally distributed and Fisher s exact test was used to compare the percentage values. Results Ninety patients were included in this study. However, three patients (one in group MB, two in group MBP) were excluded from the study because of failed IHII nerve block. There were no significant differences in terms of demographic data and duration of surgery among groups (p>0.05) (Table 1). Group M (n=30) Group MB (n=29) Group MBP (n=28) Age (year) 28.1 ± ± ± 5.6 Weight (kg) 73.8 ± ± ± 10.5 Height (cm) 156 ± ± ± 10.4 Duration of surgery (minutes) Previous caesarean delivery, n (%) 41.2 ± ± ± (77) 20 (76) 22 (78) Table 1: Demographic characteristics of patients and duration of surgery (mean±sd). No significant differences with regard to blood pressure, heart rate and oxygen saturation were found among groups (p>0.05). There were no significant differences among groups in terms of VAS scores at 1 st, 4 th, 8 th, 12 th, 18 th and 24 th hours (Figure 1). None of the patients in groups had sedation score>1 at 1 st, 4 th, 8 th, 12 th, 18 th and 24 th hours. Fig. 1: Postoperative VAS scores at rest in groups. Patients in group M (n=23, %76) had a higher rate of nausea and vomiting compared to the patients in group MB (n=12, 41%) and group MBP (n=3, %11) postoperatively (p<0.001, for both). The incidence of nausea and vomiting was found to be higher in patients in group MB compared with patients in group MBP (p<0.001). Postoperative pruritus was observed more frequently among patients in group M (n=13, 43%) compared with group MB (n=6, 20%) and group MBP (n=5, 16%) (p<0.05, p=0.001; respectively).

4 1186 Ali Pekmezci, Mehmet Cesur et Al Morphine consumption with PCIA in groups was presented in Table 2. Morphine consumption with PCIA (at 1 st, 4 th, 8 th, 12 th, 18 th and 24 th hours) was found to be higher in group M than group MB and group MBP (p<0.001, for both). Morphine consumption with PCIA (at 1 st, 4 th, 8 th, 12 th, 18 th and 24 th hours) in group MB was higher than group MBP (p<0.001). Status of patient satisfaction in groups is presented in Table 3. Patient satisfaction with postoperative analgesia was similar among groups (p>0.05). Discussion Group M (n=30) Group MB (n=29) Group MBP (n=28) 1th hour 6.5 ± 1.0* 4.9 ± 2.2# 2.1 ± 1.2 4th hour 21.2 ± 3.4* 11.3 ± 3.7# 5.3 ± 2.5 8th hour 29.0 ± 5.6* 18.9 ± 5.6# 8.3 ± th hour 42.9 ± 35.5* 25.0 ± 7.5# 11.4 ± th hour 43.7 ± 10.0* 32.3 ± 9.9# 14.1 ± th hour 50.9 ± 11.7* 36.2 ± 10.7# 16.4 ± 6.6 Table 2: Postoperative cumulative morphine consumption of groups (mg). *p<0.001: Compared with group MB and group MBP, #p< 0.001: Compared to group MBP. Group M (n=30) Group MB (n=29) Group MBP (n=28) 1 (very dissatisfied) (dissatisfied) (satisfied) (very satisfied) Table 3: Status of patient satisfaction in groups. The main finding of this study is that the combination of IV paracetamol with IHII nerve block is safe and effective for postoperative pain management in patients undergoing caesarean section under general anaesthesia and this combination reduced morphine consumption and morphine related side effects postoperatively. It also shows that the IHII nerve block alone after CS operation may also reduce postoperative morphine consumption and morphine related side effects. Inadequate postoperative analgesia may cause various postoperative complications such as delayed breastfeeding, pneumonia and deep vein thrombosis (1, 2). Numerous studies have been conducted involving post-caesarean pain management and different treatment approaches have been developed by researchers (12-14). Opioids create an analgesic effect through agonistic properties on the opioid receptors in the central nervous system (1). They are commonly used for post-caesarean pain management, although most patients complain of the side effects (e.g. nausea, vomiting and pruritus) of opioids. Opioids may cause adverse effects on new-born babies transferring to breast milk (15). In order to reduce possible side effects of opioids the cumulative dose of opioid should be reduced (1). Paracetamol is a non-opioid analgesic that has no adverse effects on the mother and her new-born. Paracetamol reduces the production of prostaglandin E2 in central nervous system and activates descending serotonergic pathways (1). The analgesic effect of paracetamol when used alone is inadequate. Therefore, IV form of paracetamol (9) has been combined with morphine for post-caesarean pain management. Hepatotoxicity is the most important side effect in association with the use of paracetamol. Therefore, it is recommended that paracetamol (1 g IV) should be administered with an interval of 6 hours and used not exceeding 4 g per day for postoperative analgesia (16). The daily dose of paracetamol in this study did not exceed 4 g. Alhashemi et al. (9) compared the analgesic effects of IV paracetamol with a dose of oral ibuprofen in patients receiving morphine PCIA after CS in patients under spinal anaesthesia. They found no difference with respect to postoperative morphine requirements between groups. Kılıcaslan et al. (8) investigated the effects of IV paracetamol combined with tramadol PCIA on postoperative tramadol consumption for post-caesarean pain control in patients under general anaesthesia. They concluded that paracetamol produces effective analgesia and reduces tramadol consumption postoperatively. We also found that IV paracetamol combined with IHII nerve block provides adequate analgesia and reduces the postoperative morphine requirement in patients undergoing elective CS under general anaesthesia. An ideal post-caesarean analgesic method should have a quick and safe analgesic effect and minimal adverse effects on the mother and her newborn. So, multimodal analgesia methods have been advanced (14). Some studies have shown the efficacy of IHII nerve block in the reduction of postopera-

5 The effect of ilioinguinal-iliohypogastric block with or without intravenous paracetamol tive pain intensity and analgesic requirement in patients who undergo caesarean delivery and inguinal hernia repair (17-19). Bell et al. (20) examined the effect of IHII nerve block on morphine consumption postoperatively in patients undergoing elective CS under spinal or epidural anaesthetic technique. They concluded that a multi-level IHII nerve block technique can reduce the amount of systemic morphine required for postoperative pain management after CS but this reduction was not associated with a reduction of opioid caused side effects. In another study, Sakalli et al. (19) found that IHII nerve block reduces postoperative analgesic consumption in patients undergoing CS with general anaesthesia and it does not reduce opioid related side effects. Similar to these results, we found greater morphine consumption in patients without IHII nerve block compared to patients with IHII nerve block for post-caesarean pain management. Unlike these studies, we observed a lower rate of opioid side effects in patients with IHII nerve block compared to patients without IHII nerve block. In this study, all patients had high scores of patient satisfaction postoperatively and there were no differences between groups in terms of patient satisfaction and pain scores. This may be because of the administration of PCIA with morphine in all patients of study groups. These results are consistent with those reported by Alhashemi et al. (9) and Wolfson et al. (13). In an earlier study, Huffnagle et al. (10) compared the analgesic effect of IHII nerve block administration before or after caesarean delivery. They used IV PCIA morphine for postoperative analgesia in all patients and they reported similar pain scores, patient satisfaction and morphine use among the groups. We found that IHII nerve block with or without IV paracetamol resulted in a reduction in postoperative morphine consumption. Their study differed from ours in that their patients were operated under spinal anaesthesia, bilateral IHII nerve block was performed using 0.5% bupivacaine, 10 ml to each side. Whereas, we used the higher dose of the same drug (15 ml for each side) and our patients were operated under general anaesthesia. With regard to the postoperative side effects of postoperative IV PCIA morphine, the patients who received the combination of IV paracetamol combined with IHII nerve block had a lower rate of nausea-vomiting compared to the patients who did not receive IV paracetamol. Additionally, pruritus incidence was found to be lower in patients with or without IV paracetamol combined with IHII nerve block compared to the patients received only IV PCIA morphine postoperatively. None of the patients received anti-emetic medication prophylactically in our study. Unlike our results, Kılıcaslan et al. (8) reported nausea and vomiting at a similar rate in patients who received IV paracetamol combined with PCIA tramadol analgesia compared to those who did not. In another study, Alhashemi et al. (9) reported higher rates of nausea-vomiting and lower incidence of pruritus in patients who received IV paracetamol+morphine PCIA compared with those who received oral ibuprofen and morphine PCIA after CS. They concluded that the central serotonergic effect of acetaminophen might have affected the occurrence of opioid related side effects. In our institute, all patients undergoing elective caesarean section are informed about advantages and disadvantages of the anaesthesia techniques by an anaesthetist preoperatively. Spinal or general anaesthesia is decided according to medical considerations and the patient s decision. Although regional anaesthesia methods are usually preferred in patients undergoing elective caesarean section in our institute (21), general anaesthesia is used in case of maternal refusal of regional techniques, failed regional attempts and in the presence of contraindications to regional anaesthesia. Patients who underwent caesarean section under general anaesthesia necessarily were enrolled in this present study. There are several limitations in the present study. First, we didn t assess VAS scores with activity. Second, we did not use ultrasonography. No doubt, ultrasonography improves the quality and safety of the IIIH blockade (22). We assessed affectivity of the block with cold and tactile sensation, and if there is an inadequate block, this patient was removed from further evaluation; so, not to use of ultrasonography would not have affected of the result of the present study. Third, we did not assess adverse effects on the new-borns such as sedation. We concluded that the use of IHII nerve block with or without IV paracetamol reduces postoperative PCIA morphine consumption providing a safe and effective postoperative analgesia with good patient satisfaction. Furthermore, this reduction is associated with a decrease in the incidence of morphine related side effects.

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