Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Surgical Endoscopy
Published in: Surgical Endoscopy 2/2017

01-02-2017

Prospective randomized controlled trial comparing standard analgesia with combined intra-operative cystic plate and port-site local anesthesia for post-operative pain management in elective laparoscopic cholecystectomy

Authors: Mladjan Protic, Radovan Veljkovic, Anton J. Bilchik, Ana Popovic, Milana Kresoja, Aviram Nissan, Itzhak Avital, Alexander Stojadinovic

Published in: Surgical Endoscopy | Issue 2/2017

Login to get access

Abstract

Background

Various mechanisms, including somatic and visceral nociceptive stimulation, have been suggested as a cause for pain after laparoscopic cholecystectomy (LC). We therefore conducted a prospective randomized controlled trial (PRCT) to evaluate whether somatovisceral pain blockade reduces pain after LC.

Hypothesis

Analgesic efficacy of multimodal analgesia is superior to standard analgesia for patients undergoing elective LC for symptomatic cholelithiasis. Specifically, topical cystic plate and port-site injection with 0.25 % bupivacaine significantly reduces pain after LC.

Design

This study was designed as single-blinded PRCT.

Setting

This study was conducted in an academic medical center.

Patients and methods

Between February and May 2010 we randomly assigned 63 patients with symptomatic cholelithiasis in a 1:1 ratio to non-opioid/opioid analgesic combinations (Control Group, n = 32) and non-opioid/opioid analgesic combinations plus topical 0.25 % bupivacaine onto the cystic plate and local 0.25 % bupivacaine port-site injection, post-LC (Study Group, n = 31). Primary endpoint was patient-reported pain 1, 4, 6, 12, 24 h and 1 week post-LC using the Visual Analog Scale (VAS 0–10).

Results

Study groups were comparable clinicopathologically. There were no adverse events. A statistically significant reduction in mean pain score was apparent in Study Group patients in comparison with Control Group (mean VAS 4.83 ± 2.33 vs. 6.80 ± 1.87; p < 0.001) at all early (1–6 h) post-operative time points following LC.

Conclusion

This PRCT shows significantly improved pain control with somatovisceral pain blockade over non-opioid/opioid analgesic combinations following LC for symptomatic cholelithiasis. For centers not utilizing adjunctive local anesthetic for LC, this topical use of bupivacaine may improve patient comfort during recovery.
This trial was registered on www.​ClinicalTrials.​gov NCT# 01972620.
Literature
1.
Rosenmüller M, Haapamäki MM, Nordin P, Stenlund H, Nilsson E (2007) Cholecystectomy in Sweden 2000–2003: a nationwide study on procedures, patient characteristics, and mortality. BMC Gastroenterol 7:35CrossRefPubMedPubMedCentral
2.
3.
Keus F, de Jong JAF, Gooszen HG, van Laarhoven CJHM (2006) Laparoscopic versus open cholecystectomy for patients with symptomatic cholecystolithiasis. Cochrane Database Syst Rev 4:CD006231
4.
Keus F, Gooszen HG, van Laarhoven CJ (2010) Open, small-incision, or laparoscopic cholecystectomy for patients with symptomatic cholecystolithiasis. An overview of Cochrane Hepato-Biliary Group reviews. Cochrane Database Syst Rev 1:CD008318
5.
Keus F, Gooszen HG, Van Laarhoven CJHM (2009) Systematic review: open, small-incision or laparoscopic cholecystectomy for symptomatic cholecystolithiasis. Aliment Pharmacol Ther 29(4):359–378CrossRefPubMed
6.
Steiner CA, Bass EB, Talamini MA, Pitt HA, Steinberg EP (1994) Surgical rates and operative mortality for open and laparoscopic cholecystectomy in Maryland. N Engl J Med 330(6):403–408CrossRefPubMed
7.
8.
9.
10.
Boddy AP, Mehta S, Rhodes M (2006) The effect of intraperitoneal local anesthesia in laparoscopic cholecystectomy: a systematic review and meta-analysis. Anesth Analg 103(3):682–688CrossRefPubMed
11.
Joris J, Thiry E, Paris P, Weerts J, Lamy M (1995) Pain after laparoscopic cholecystectomy: characteristics and effect of intraperitoneal bupivacaine. Anesth Analg 81(2):379–384PubMed
12.
Verma GR, Lyngdoh TS, Kaman L, Bala I (2006) Placement of 0.5% bupivacaine-soaked Surgicel in the gallbladder bed is effective for pain after laparoscopic cholecystectomy. Surg Endosc 20(10):1560–1564CrossRefPubMed
13.
Lee IO, Kim SH, Kong MH, Lee MK, Kim NS, Choi YS et al (2001) Pain after laparoscopic cholecystectomy: the effect and timing of incisional and intraperitoneal bupivacaine. Can J Anaesth 48(6):545–550CrossRefPubMed
14.
Bisgaard T, Klarskov B, Kristiansen VB, Callesen T, Schulze S, Kehlet H et al (1999) Multi-regional local anesthetic infiltration during laparoscopic cholecystectomy in patients receiving prophylactic multi-modal analgesia: a randomized, double-blinded, placebo-controlled study. Anesth Analg 89(4):1017–1024PubMed
15.
Gupta A (2005) Local anaesthesia for pain relief after laparoscopic cholecystectomy–a systematic review. Best Pract Res Clin Anaesthesiol 19(2):275–292CrossRefPubMed
16.
Tsimoyiannis EC, Siakas P, Tassis A, Lekkas ET, Tzourou H, Kambili M (1998) Intraperitoneal normal saline infusion for postoperative pain after laparoscopic cholecystectomy. World J Surg 22(8):824–828CrossRefPubMed
17.
Pappas-Gogos G, Tsimogiannis KE, Zikos N, Nikas K, Manataki A, Tsimoyiannis EC (2008) Preincisional and intraperitoneal ropivacaine plus normal saline infusion for postoperative pain relief after laparoscopic cholecystectomy: a randomized double-blind controlled trial. Surg Endosc 22(9):2036–2045CrossRefPubMed
18.
Lepner U, Goroshina J, Samarütel J (2003) Postoperative pain relief after laparoscopic cholecystectomy: a randomised prospective double-blind clinical trial. Scand J Surg 92(2):121–124PubMed
19.
Gurusamy KS, Nagendran M, Guerrini GP, Toon CD, Zinnuroglu M, Davidson BR (2014) Intraperitoneal local anaesthetic instillation versus no intraperitoneal local anaesthetic instillation for laparoscopic cholecystectomy. Cochrane Database Syst Rev 3:CD007337
20.
Loizides S, Gurusamy KS, Nagendran M, Rossi M, Guerrini GP, Davidson BR (2014) Wound infiltration with local anaesthetic agents for laparoscopic cholecystectomy. Cochrane Database Syst Rev 3:CD007049
21.
Schulz KF, Altman DG, Moher D (2010) CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med 152(11):726–732CrossRefPubMed
22.
Bisgaard T, Klarskov B, Rosenberg J, Kehlet H (2001) Factors determining convalescence after uncomplicated laparoscopic cholecystectomy. Arch Surg 136(8):917–921CrossRefPubMed
23.
Bisgaard T, Kehlet H, Rosenberg J (2001) Pain and convalescence after laparoscopic cholecystectomy. Eur J Surg 167(2):84–96CrossRefPubMed
24.
Abdallah FW, Chan VW, Brull R (2012) Transversus abdominis plane block: a systematic review. Reg Anesth Pain Med 37(2):193–209CrossRefPubMed
25.
Kahokehr A, Sammour T, Soop M, Hill AG (2011) Intraperitoneal local anaesthetic in abdominal surgery—a systematic review. ANZ J Surg 81(4):237–245CrossRefPubMed
26.
Inan A, Sen M, Dener C (2004) Local anesthesia use for laparoscopic cholecystectomy. World J Surg 28(8):741–744CrossRefPubMed
27.
Sarvestani AS, Amini S, Kalhor M, Roshanravan R, Mohammadi M, Lebaschi AH (2013) Intraperitoneal hydrocortisone for pain relief after laparoscopic cholecystectomy. Saudi J Anaesth 7(1):14–17CrossRefPubMedPubMedCentral
28.
Hernández-Palazón J, Tortosa JA, Nuño de la Rosa V, Giménez-Viudes J, Ramírez G, Robles R (2003) Intraperitoneal application of bupivacaine plus morphine for pain relief after laparoscopic cholecystectomy. Eur J Anaesthesiol 20(11):891–896CrossRefPubMed
29.
30.
Griffin EM, Prystowsky H, Hingson RA (1951) The use of topical anaesthesia of the peritoneum in poor risk surgery and in augmenting inadequate vertebral conduction anaesthesia. N Z Med J 50(275):31–33PubMed
31.
Mitra S, Khandelwal P, Roberts K, Kumar S, Vadivelu N (2012) Pain relief in laparoscopic cholecystectomy–a review of the current options. Pain Pract 12(6):485–496CrossRefPubMed
32.
Slim K, Bousquet J, Kwiatkowski F, Pezet D, Chipponi J (1997) Analysis of randomized controlled trials in laparoscopic surgery. Br J Surg 84(5):610–614CrossRefPubMed
33.
Fuhrer Y, Charpentier C, Boulanger G, Menu N, Grosdidier G, Laxenaire MC (1996) Analgesia after laparoscopic cholecystectomy by intraperitoneal administration of bupivacaine. Ann Fr Anesth Reanim 15(2):128–134CrossRefPubMed
34.
Raetzell M, Maier C, Schröder D, Wulf H (1995) Intraperitoneal application of bupivacaine during laparoscopic cholecystectomy–risk or benefit? Anesth Analg 81(5):967–972PubMed
35.
Pavlidis TE, Atmatzidis KS, Papaziogas BT, Makris JG, Lazaridis CN, Papaziogas TB (2003) The effect of preincisional periportal infiltration with ropivacaine in pain relief after laparoscopic procedures: a prospective, randomized controlled trial. JSLS 7(4):305–310PubMedPubMedCentral
36.
Noma H, Kakiuchi H, Nojiri K, Izumi R, Tashiro C (2001) Evaluation of postoperative pain relief by infiltration of bupivacaine or epidural block after laparoscopic cholecystectomy. Masui 50(11):1201–1204PubMed
37.
Rodríguez-Navarro AJ, Berde CB, Wiedmaier G, Mercado A, Garcia C, Iglesias V et al (2001) Comparison of neosaxitoxin versus bupivacaine via port infiltration for postoperative analgesia following laparoscopic cholecystectomy: a randomized, double-blind trial. Reg Anesth Pain Med 36(2):103–109CrossRef
38.
Pourseidi B, Khorram-Manesh A (2007) Effect of intercostals neural blockade with Marcaine (bupivacaine) on postoperative pain after laparoscopic cholecystectomy. Surg Endosc 21(9):1557–1559CrossRefPubMed
39.
Cunniffe MG, McAnena OJ, Dar MA, Calleary J, Flynn N (1998) A prospective randomized trial of intraoperative bupivacaine irrigation for management of shoulder-tip pain following laparoscopy. Am J Surg 176(3):258–261CrossRefPubMed
40.
Elfberg BA, Sjövall-Mjöberg S (2000) Intraperitoneal bupivacaine does not effectively reduce pain after laparoscopic cholecystectomy: a randomized, placebo-controlled and double-blind study. Surg Laparosc Endosc Percutan Tech 10(6):357–359CrossRefPubMed
41.
Cha SM, Kang H, Baek CW, Jung YH, Koo GH, Kim BG et al (2012) Peritrocal and intraperitoneal ropivacaine for laparoscopic cholecystectomy: a prospective, randomized, double-blind controlled trial. J Surg Res 175(2):251–258CrossRefPubMed
42.
Liu Y-Y, Yeh C-N, Lee H-L, Wang S-Y, Tsai C-Y, Lin C-C et al (2009) Local anesthesia with ropivacaine for patients undergoing laparoscopic cholecystectomy. World J Gastroenterol 15(19):2376–2380CrossRefPubMedPubMedCentral
43.
Labaille T, Mazoit JX, Paqueron X, Franco D, Benhamou D (2002) The clinical efficacy and pharmacokinetics of intraperitoneal ropivacaine for laparoscopic cholecystectomy. Anesth Analg 94(1):100–105PubMed
44.
Coughlin SM, Karanicolas PJ, Emmerton-Coughlin HMA, Kanbur B, Kanbur S, Colquhoun PHD (2010) Better late than never? Impact of local analgesia timing on postoperative pain in laparoscopic surgery: a systematic review and metaanalysis. Surg Endosc 24(12):3167–3176CrossRefPubMed
45.
Kahokehr A, Sammour T, Soop M, Hill AG (2010) Intraperitoneal use of local anesthetic in laparoscopic cholecystectomy: systematic review and metaanalysis of randomized controlled trials. J Hepatobiliary Pancreat Sci 17(5):637–656CrossRefPubMed
46.
Gupta A, Thörn SE, Axelsson K, Larsson LG, Agren G, Holmström B et al (2002) Postoperative pain relief using intermittent injections of 0.5% ropivacaine through a catheter after laparoscopic cholecystectomy. Anesth Analg 95(2):450–456PubMed
47.
Ure BM, Troidl H, Spangenberger W, Dietrich A, Lefering R, Neugebauer E (1994) Pain after laparoscopic cholecystectomy. Intensity and localization of pain and analysis of predictors in preoperative symptoms and intraoperative events. Surg Endosc 8(2):90–96CrossRefPubMed
48.
Nicolau AE, Merlan V, Grecu I, Nicolau M, Micu B (2008) Multimodal analgesia in elective laparoscopic cholecystectomy. A double-blind randomized controlled trial. Chirurgia (Bucur) 103(5):547–551
49.
Cantore F, Boni L, Di Giuseppe M, Giavarini L, Rovera F, Dionigi G (2008) Pre-incision local infiltration with levobupivacaine reduces pain and analgesic consumption after laparoscopic cholecystectomy: a new device for day-case procedure. Int J Surg 6(Suppl 1):S89–S92CrossRefPubMed
50.
Buggy DJ, Wall C, Carton EG (1994) Preoperative or postoperative diclofenac for laparoscopic tubal ligation. Br J Anaesth 73(6):767–770CrossRefPubMed
51.
Papagiannopoulou P, Argiriadou H, Georgiou M, Papaziogas B, Sfyra E, Kanakoudis F (2003) Preincisional local infiltration of levobupivacaine vs ropivacaine for pain control after laparoscopic cholecystectomy. Surg Endosc 17(12):1961–1964CrossRefPubMed
52.
Uzunköy A, Coskun A, Akinci OF (2001) The value of pre-emptive analgesia in the treatment of postoperative pain after laparoscopic cholecystectomy. Eur Surg Res 33(1):39–41CrossRefPubMed
53.
Karaaslan D, Sivaci RG, Akbulut G, Dilek ON (2006) Preemptive analgesia in laparoscopic cholecystectomy: a randomized controlled study. Pain Pract 6(4):237–241CrossRefPubMed
54.
El-Dawlatly AA, Turkistani A, Kettner SC, Machata A-M, Delvi MB, Thallaj A et al (2009) Ultrasound-guided transversus abdominis plane block: description of a new technique and comparison with conventional systemic analgesia during laparoscopic cholecystectomy. Br J Anaesth 102(6):763–767CrossRefPubMed
55.
Ortiz J, Suliburk JW, Wu K, Bailard NS, Mason C, Minard CG et al (2012) Bilateral transversus abdominis plane block does not decrease postoperative pain after laparoscopic cholecystectomy when compared with local anesthetic infiltration of trocar insertion sites. Reg Anesth Pain Med 37(2):188–192CrossRefPubMed
56.
Hilvering B, Draaisma WA, van der Bilt JDW, Valk RM, Kofman KE, Consten ECJ (2011) Randomized clinical trial of combined preincisional infiltration and intraperitoneal instillation of levobupivacaine for postoperative pain after laparoscopic cholecystectomy. Br J Surg 98(6):784–789CrossRefPubMed
57.
Boccara G, Chaumeron A, Pouzeratte Y, Mann C (2005) The preoperative administration of ketoprofen improves analgesia after laparoscopic cholecystectomy in comparison with propacetamol or postoperative ketoprofen. Br J Anaesth 94(3):347–351CrossRefPubMed
58.
Papadima A, Lagoudianakis EE, Antonakis P, Filis K, Makri I, Markogiannakis H et al (2009) Repeated intraperitoneal instillation of levobupivacaine for the management of pain after laparoscopic cholecystectomy. Surgery 146(3):475–482CrossRefPubMed
59.
Jabbour-Khoury SI, Dabbous AS, Gerges FJ, Azar MS, Ayoub CM, Khoury GS (2005) Intraperitoneal and intravenous routes for pain relief in laparoscopic cholecystectomy. JSLS 9(3):316–321PubMedPubMedCentral
60.
Louizos AA, Hadzilia SJ, Leandros E, Kouroukli IK, Georgiou LG, Bramis JP (2005) Postoperative pain relief after laparoscopic cholecystectomy: a placebo-controlled double-blind randomized trial of preincisional infiltration and intraperitoneal instillation of levobupivacaine 0.25%. Surg Endosc 19(11):1503–1506CrossRefPubMed
61.
DeLoach LJ, Higgins MS, Caplan AB, Stiff JL (1998) The visual analog scale in the immediate postoperative period: intrasubject variability and correlation with a numeric scale. Anesth Analg 86(1):102–106PubMed
62.
Schwenk W, Mall JW, Neudecker J, Müller JM (2002) One visual analogue pain score is sufficient after laparoscopic cholecystectomy. Br J Surg 89(1):114–115CrossRefPubMed
63.
Liang H, Feng Y, Liu Y, An H, Yang B (2011) Effect of flurbiprofen combined different concentrations of ropivacaine local infiltration on postoperative analgesia after laparoscopic cholecystectomy. Beijing Da Xue Xue Bao 43(5):753–756PubMed
64.
Collard V, Mistraletti G, Taqi A, Asenjo JF, Feldman LS, Fried GM et al (2007) Intraoperative esmolol infusion in the absence of opioids spares postoperative fentanyl in patients undergoing ambulatory laparoscopic cholecystectomy. Anesth Analg 105(5):1255–1262CrossRefPubMed
65.
Michaloliakou C, Chung F, Sharma S (1996) Preoperative multimodal analgesia facilitates recovery after ambulatory laparoscopic cholecystectomy. Anesth Analg 82(1):44–51PubMed
Metadata
Title
Prospective randomized controlled trial comparing standard analgesia with combined intra-operative cystic plate and port-site local anesthesia for post-operative pain management in elective laparoscopic cholecystectomy
Authors
Mladjan Protic
Radovan Veljkovic
Anton J. Bilchik
Ana Popovic
Milana Kresoja
Aviram Nissan
Itzhak Avital
Alexander Stojadinovic
Publication date
01-02-2017
Publisher
Springer US
Published in
Surgical Endoscopy / Issue 2/2017
Print ISSN: 0930-2794
Electronic ISSN: 1432-2218
DOI
https://doi.org/10.1007/s00464-016-5024-5

Other articles of this Issue 2/2017

Surgical Endoscopy 2/2017 Go to the issue

OriginalPaper

Intraoperative workload in robotic surgery assessed by wearable motion tracking sensors and questionnaires

OriginalPaper

Is the benefit of laparoscopy maintained in elderly patients undergoing rectal cancer resection? An analysis of 446 consecutive patients

OriginalPaper

A combined thoracoscopic and laparoscopic approach for high epiphrenic diverticula and the importance of complete myotomy

OriginalPaper

Endoscopic subcutaneous component separation as an adjunct to abdominal wall reconstruction

OriginalPaper

Increased use of surgical energy promotes methicillin-resistant Staphylococcus aureus colonization in rabbits following open ventral hernia mesh repair

OriginalPaper

Reduced postoperative pain scores and narcotic use favor per-oral endoscopic myotomy over laparoscopic Heller myotomy