RCT: Multi-modal Analgesia for Laparoscopic Cholecystectomy

NCT01972620 | Completed DMC

• 1 other identifier: 00-01/515
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Analgesic efficacy of multi-modal analgesia is superior to standard analgesia for patients undergoing elective laparoscopic cholecystectomy for symptomatic cholelithiasis. Topical cystic plate and port-site incision 0.25% bupivacaine significantly reduces pain after laparoscopic cholecystectomy.

Conditions

Gallstones; Cholelithiasis; Pain

Keywords

gallstones; cholelithiasis; cholecystectomy, laparoscopic; pain

Outcome Measures

Primary Outcomes (1)

• Visual Scale Pain VAS

  The primary endpoint was patient-reported pain 1, 4, 6, 12, and 24 hours, and 7 days following laparoscopic cholecystectomy using the Visual Acuity Score (VAS, 0-10).

  from 0 to 7 postoperative days

Secondary Outcomes (1)

• nausea

  from 0 to 6 hours post-operatively

Other Outcomes (1)

• mobility

  from 0 to 7 postoperative days

Study Arms (2)

Multi-modal analgesia

ACTIVE COMPARATOR

Thirty-one patients were enrolled in this arm. Standard analgesia according to institutional standard and 50:50 mixture of normal saline (8 ml) and 0.5% Bupivacaine was prepared within a 20 ml syringe (Total volume = 16 ml; Final concentration = 0.25%). Following delivery of the gallbladder specimen 8 ml of 0.25% bupivacaine solution was sprayed onto the cystic plate (gallbladder fossa) with a spinal needle advanced under direct laparoscopic vision via a 5mm right subcostal laparoscopic port. The anesthetic solution was sprayed at an operating distance from the cystic plate of \~ 2 cm. Following evacuation of the pneumoperitoneum, the remaining 8 ml of 0.25% Bupivacaine was infiltrated subcutaneously at each of the 4 laparoscopic port sites (2 ml per port site) prior sutured closure.

Drug: Bupivacaine

Control

NO INTERVENTION

Thirty-two patients were enrolled in this arm. They received standard analgesia according to institutional standard of practice consisted of non-narcotic analgesia with narcotic analgesic rescue after laparoscopic cholecystectomy.

Interventions

Bupivacaine DRUG

A 50:50 mixture of normal saline (8 ml) and 0.5% Bupivacaine was prepared within a 20 ml syringe (Total volume 16 ml; Final concentration = 0.25%). Following delivery of the gallbladder specimen in the Multi-modal analgesia group, 8 ml of 0.25% bupivacaine solution was sprayed onto the cystic plate (gallbladder fossa) with a spinal needle advanced under direct laparoscopic vision via a 5mm right subcostal laparoscopic port. The anesthetic solution was sprayed at an operating distance from the cystic plate of \~ 2 cm. Following evacuation of the pneumoperitoneum, again within the Multi-modal analgesia group, the remaining 8 ml of 0.25% Bupivacaine was infiltrated subcutaneously at each of the four laparoscopic port sites (2 ml per port site) prior to standard sutured closure of each incision

Also known as: Marcaine, Bupivacaine HCL

Multi-modal analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• symptomatic cholelithiasis undergo elective laparoscopic cholecystectomy
• non - pregnant women
• years or older

You may not qualify if:

• undergoing urgent cholecystectomy
• patients operated on for indications other than symptomatic cholelithiasisT
• those having conversion from laparoscopic to open cholecystectomy
• those that withdrew from the study for any reason before the end of the required 7-day follow up (including those that died during that period)
• those with incomplete data.

Sponsors & Collaborators

• Klinicki Centar Vojvodine: lead

Study Sites (1)

Klinicki Centar Vojvodine

Novi Sad, Vojvodina, 21000, Serbia

Location

Related Publications (4)

• Verma GR, Lyngdoh TS, Kaman L, Bala I. Placement of 0.5% bupivacaine-soaked Surgicel in the gallbladder bed is effective for pain after laparoscopic cholecystectomy. Surg Endosc. 2006 Oct;20(10):1560-4. doi: 10.1007/s00464-005-0284-5. Epub 2006 Aug 1.

  PMID: 16897291 RESULT

• Boddy AP, Mehta S, Rhodes M. The effect of intraperitoneal local anesthesia in laparoscopic cholecystectomy: a systematic review and meta-analysis. Anesth Analg. 2006 Sep;103(3):682-8. doi: 10.1213/01.ane.0000226268.06279.5a.

  PMID: 16931681 RESULT

• Mitra S, Khandelwal P, Roberts K, Kumar S, Vadivelu N. Pain relief in laparoscopic cholecystectomy--a review of the current options. Pain Pract. 2012 Jul;12(6):485-96. doi: 10.1111/j.1533-2500.2011.00513.x. Epub 2011 Oct 19.

  PMID: 22008277 RESULT

• Gupta A. Local anaesthesia for pain relief after laparoscopic cholecystectomy--a systematic review. Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):275-92. doi: 10.1016/j.bpa.2004.12.007.

  PMID: 15966498 RESULT

MeSH Terms

Conditions

Gallstones; Cholelithiasis; Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Radovan Veljkovic, MD, PhD

  Clinical Centre of Vojvodina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, ass. prof

Study Record Dates

• First Submitted: October 16, 2013
• First Posted: October 30, 2013
• Study Start: February 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: October 30, 2013

Record last verified: 2013-10

Locations

SE (1)