TY - JOUR
AU - Finch, J G
AB - Abstract Background Shoulder tip and abdominal pain following laparoscopic procedures are well recognized causes of postoperative morbidity. In this double-blind randomized clinical trial attempts were made to reduce postoperative pain in patients undergoing laparoscopic surgery by implementing a simple intraoperative technique. Methods Patients undergoing elective laparoscopic cholecystectomy or laparoscopic transabdominal preperitoneal inguinal hernia repair were randomized to receive either the current standard treatment (control group) or an intervention to remove residual carbon dioxide. In the intervention group, the pneumoperitoneum was removed at the end of the operation by placing the patient in the Trendelenburg position and utilizing a pulmonary recruitment manoeuvre consisting of two manual inflations to a maximum pressure of 60 cmH2O. In the control group, residual pneumoperitoneum was evacuated at the end of the procedure by passive decompression via the open operative ports. Results Seventy-six randomly assigned patients, 37 in the intervention group and 39 in the control group, were recruited. Overall postoperative pain scores were significantly lower in the intervention group (P = 0·001). Median (interquartile range) pain scores were significantly lower in the intervention group compared with the control group at both 12 h (3·5 versus 5; P < 0·010) and 24 h (3 versus 4·5; P < 0·010). Conclusion Active evacuation of residual pneumoperitoneum following laparoscopic procedures, by means of two pulmonary recruitment manoeuvres in the Trendelenburg position, reduces postoperative pain significantly. This simple and safe technique can be implemented routinely after abdominal laparoscopy. Registration number: NCT01720433 (http://www.clinicaltrials.gov). Introduction Shoulder tip and abdominal pain following laparoscopic procedures are well recognized and established causes of postoperative morbidity1,2. Mechanisms to reduce pain intensity include a reduction in pneumoperitoneal pressure3, administration of non-steroidal anti-inflammatory drugs (NSAIDs)4–6, use of intraperitoneal local anaesthetic agents7–9, infiltration of wounds with local anaesthetic10,11 and removal of gases12–14. The aetiology of postoperative pain is multifactorial and includes the volume of residual gas, type of gas used, intraperitoneal pressures resulting from establishment of the pneumoperitoneum, and temperature of the insufflated gas2,15–17. Simple clinical manoeuvres performed during surgery can reduce shoulder tip pain as well as postoperative nausea and vomiting18. This double-blind randomized clinical trial (RCT) attempted to address the hypothesis that implementation of a simple intraoperative technique of pulmonary recruitment after surgery would reduce postoperative pain in patients undergoing laparoscopic surgery. An earlier similar study showed beneficial results in gynaecological procedures18, and this trial attempted to validate those findings in a general surgery population. Methods To improve reporting and promote transparency, this RCT was designed according to the principles of the Consolidated Standards of Reporting Trials (CONSORT) statement. All patients were recruited from a single consultant's surgical clinic at the same district general hospital between August 2010 and February 2012. The study was approved by the local ethics committee and informed consent was obtained from all patients after they had studied information leaflets. The trial was designed as a randomized double-blind trial with a 1 : 1 (control : intervention) allocation. Included patients were adults with an American Society of Anesthesiologists (ASA) physical status grade I or II, undergoing elective laparoscopic cholecystectomy for gallbladder disease or laparoscopic inguinal hernia repair performed as a transabdominal preperitoneal procedure. Preoperative exclusion criteria included age less than 18 years, refusal to give consent, inability to understand the research questionnaire, and pregnancy. Patients who were found to require additional procedures, such as conversion to open surgery, were excluded from the study before analysis. The laparoscopic procedures in this study were all performed by, or under the supervision of, one consultant surgeon using standard techniques. Open cut-down was performed at the umbilicus in all patients, and carbon dioxide insufflation was commenced at a rate of 1 l/min until an abdominal pressure of 14 mmHg had been reached. Laparoscopic procedures were then performed at an insufflation rate of 12 l/min. Randomization of patients was carried out at completion of the procedure with patients allocated to standard care (control group) or intervention. In the control group, residual carbon dioxide pneumoperitoneum was evacuated passively at the end of the procedure by opening the operative ports to allow the abdomen to decompress. In the intervention group, in addition to the above, the patient was placed in the Trendelenburg position (30°) and a pulmonary recruitment manoeuvre was utilized, consisting of two manual inflations to a maximum pressure of 60 cmH2O. This was performed by the anaesthetist, who held each positive pressure inflation for 5 s, with the valves on the operative ports fully open. All patients were randomized individually. Randomization was performed by a computer-generated random number determining intervention (even numbers) or control (odd numbers), by a third party (the anaesthetic team) with the operating team outside the operating theatre behind closed doors. In effect, the surgical team was absent from theatre while the intervention or control was instigated. The operating team, which also completed the postoperative assessments, was thus blinded to the assignment of interventions, as was the patient. The randomization number was placed in a sealed envelope and opened only after completion of the study. Duration of surgery, intraoperative and postoperative complications, and reasons for converting to open operation were recorded, as were patient demographics. All patients were prescribed standard oral postoperative analgesia, which included 1 g paracetamol four times daily and 50 mg tramadol four times daily, as required. The primary outcome measure was postoperative pain in general, and included both abdominal and shoulder tip pain. Patients were discharged on the day of operation. Pain scores were assessed at 6, 12, 24 and 48 h by use of a validated visual analogue scale (VAS) (0, no pain; 10, worst conceivable pain), rounded to the nearest whole number. Statistical analysis To establish an overall difference between intervention and control groups, it was determined that 31 patients would be required in each treatment arm to detect a 20 per cent difference in mean pain scores with a probability of 90 per cent and two-sided significance level of 0·05. Demographic data were compared using the Mann–Whitney U test for non-categorical variables, and Fisher's exact test or χ2 test for categorical variables. Postoperative pain scores were compared using a two-way repeated-measures ANOVA with Bonferroni's multiple comparisons post-test. All postoperative pain data were normally distributed (D'Agostino–Pearson omnibus test). Statistical analysis was performed using GraphPad Prism® 6 (GraphPad Software, La Jolla, California, USA). All tests were two-tailed and P < 0·050 was taken as significant. Results Between August 2010 and February 2012, 127 suitable consecutive patients were recruited. Fig. 1 depicts a CONSORT diagram of patient recruitment, including the reasons for exclusion from analysis. The two groups were similar with respect to age, sex, body mass index, type of surgery and ASA grade (Table 1). Fig. 1 Open in new tabDownload slide CONSORT diagram for the trial Table 1 Demographics of patients assigned to control and intervention groups . Control (n = 39) . Intervention (n = 37) . P . Age (years)* 53 (38–64) 43·5 (33–65) 0·461† Sex ratio (M : F) 16 : 23 21 : 16 0·251‡ Operation 0·814‡     Laparoscopic cholecystectomy 25 22     Laparoscopic inguinal hernia repair 14 15 ASA grade 0·256§     I 22 16     II 16 17     III 1 4 Body mass index (kg/m2)* 28·7 (22·4–36·6) 27·0 (22·4–36·6) 0·331† . Control (n = 39) . Intervention (n = 37) . P . Age (years)* 53 (38–64) 43·5 (33–65) 0·461† Sex ratio (M : F) 16 : 23 21 : 16 0·251‡ Operation 0·814‡     Laparoscopic cholecystectomy 25 22     Laparoscopic inguinal hernia repair 14 15 ASA grade 0·256§     I 22 16     II 16 17     III 1 4 Body mass index (kg/m2)* 28·7 (22·4–36·6) 27·0 (22·4–36·6) 0·331† * Values are median (interquartile range). ASA, American Society of Anesthesiologists. † Mann–Whitney U test, ‡ Fisher's exact test, § χ2 test. Open in new tab Table 1 Demographics of patients assigned to control and intervention groups . Control (n = 39) . Intervention (n = 37) . P . Age (years)* 53 (38–64) 43·5 (33–65) 0·461† Sex ratio (M : F) 16 : 23 21 : 16 0·251‡ Operation 0·814‡     Laparoscopic cholecystectomy 25 22     Laparoscopic inguinal hernia repair 14 15 ASA grade 0·256§     I 22 16     II 16 17     III 1 4 Body mass index (kg/m2)* 28·7 (22·4–36·6) 27·0 (22·4–36·6) 0·331† . Control (n = 39) . Intervention (n = 37) . P . Age (years)* 53 (38–64) 43·5 (33–65) 0·461† Sex ratio (M : F) 16 : 23 21 : 16 0·251‡ Operation 0·814‡     Laparoscopic cholecystectomy 25 22     Laparoscopic inguinal hernia repair 14 15 ASA grade 0·256§     I 22 16     II 16 17     III 1 4 Body mass index (kg/m2)* 28·7 (22·4–36·6) 27·0 (22·4–36·6) 0·331† * Values are median (interquartile range). ASA, American Society of Anesthesiologists. † Mann–Whitney U test, ‡ Fisher's exact test, § χ2 test. Open in new tab There was no significant difference in median (interquartile range, i.q.r.) preoperative pain scores in the control versus intervention group (0 (0–3) versus 0 (0–2); P = 0·472). Overall postoperative pain scores were significantly lower in the intervention group (P < 0·001, 2-way repeated-measures ANOVA). The intervention accounted for 7·2 per cent of the total variance, after adjustment for matching (F = 10·35, 1 d.f.). With Bonferroni post-testing, both 12-h (3 (1–5) versus 5 (3–6); P < 0·010) and 24-h (3 (1·5–4·5) versus 4·5 (3–6); P < 0·010) pain scores were significantly lower in the intervention group (Fig. 2). Implementation of the intervention did not result in any additional morbidity (data not shown). Fig. 2 Open in new tabDownload slide Median postoperative pain scores in control and intervention groups. *P < 0·010 (2-way repeated-measures ANOVA with Bonferroni's multiple comparisons post-test) Discussion In this double-blind RCT, active evacuation of residual pneumoperitoneum following laparoscopic procedures by the administration of two pulmonary recruitment manoeuvres in the Trendelenburg position was effective in reducing pain significantly at 12 and 24 h after surgery. Routine use of this intervention should be considered at the end of all intra-abdominal laparoscopic procedures. The incidence of postoperative shoulder tip pain is a well recognized complication of laparoscopic surgery19,20. It is encouraging that the incidence of pain in the control group in the present study was comparable to that reported previously21,22. Early pain after laparoscopic procedures is multifactorial and complex, resulting from a variety of different mechanisms. Abdominal wall penetration by trocar placement involves a somatic component23. Rapid insufflation of the peritoneum by carbon dioxide may cause tearing of blood vessels, traction of nerves and release of proinflammatory cytokines, producing visceral pain3,24–26. The ensuing inflammation and local irritation subsequent to peritoneal and visceral manipulation during surgery also contributes. The exact mechanism of shoulder pain after laparoscopic surgery remains unclear. Irritation of the phrenic nerve may cause referred pain via C4, which may then be projected to the shoulder. The aetiology of this irritation may also be multifactorial, with local acidosis27, distension of the diaphragm, and irritation secondary to retained abdominal carbon dioxide all playing a role28,29. Although it is generally regarded as a symptom related to carbon dioxide pneumoperitoneum, shoulder pain may also occur during gasless laparoscopic surgery30,31. A small proportion of patients develop severe shoulder tip pain that impacts upon their quality of life32, and some may go on to develop chronic pain33. NSAIDs are often employed as adjuvant therapy during and after surgery, but were avoided in this trial. They have the benefit of analgesic properties comparable to those of opioid compounds, but without opioid-related side-effects. Systematic reviews suggest that a multimodal analgesic regimen consisting of a single preoperative dose of dexamethasone, incisional local anaesthetics and continuous treatment with NSAIDs is effective at reducing pain34,35. A criticism of the present study is that the volume of the residual pneumoperitoneum was not measured. An electronic variable-flow insufflator of carbon dioxide, as used during the operation, terminates flow when a preset intra-abdominal pressure is reached (14 mmHg). The volume of residual pneumoperitoneum is proportional to the compliance and size of the abdomen. Owing to technical difficulty in quantifying these factors, their assessment would not have contributed to this study of postoperative pain. In addition, the nature of the gas in the residual pneumoperitoneum was not assessed; as well as carbon dioxide, the pneumoperitoneum may also contain the products of tissue combustion. However, as all patients received anaesthetic and surgical techniques that had been standardized in all other ways, there is no reason to suppose that these factors influenced postoperative pain. Disclosure The authors declare no conflict of interest. References 1 Mouton WG , Bessell JR, Otten KT, Maddern GJ. Pain after laparoscopy . Surg Endosc 1999 ; 13 : 445 – 448 . Google Scholar Crossref Search ADS PubMed WorldCat 2 Wills VL , Hunt DR. Pain after laparoscopic cholecystectomy . Br J Surg 2000 ; 87 : 273 – 284 . Google Scholar Crossref Search ADS PubMed WorldCat 3 Sandhu T , Yamada S, Ariyakachon V, Chakrabandhu T, Chongruksut W, Ko-iam W. 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Published by John Wiley & Sons, Ltd This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model) © 2013 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd
TI - Randomized clinical trial of a simple pulmonary recruitment manoeuvre to reduce pain after laparoscopy
JF - British Journal of Surgery
DO - 10.1002/bjs.9202
DA - 2013-08-12
UR - https://www.deepdyve.com/lp/oxford-university-press/randomized-clinical-trial-of-a-simple-pulmonary-recruitment-manoeuvre-2iRSemh0JA
SP - 1290
EP - 1294
VL - 100
IS - 10
DP - DeepDyve
ER -