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RCT: Multi-modal Analgesia for Laparoscopic Cholecystectomy (LapChole)

Primary Purpose

Gallstones, Cholelithiasis, Pain

Status
Completed
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
Bupivacaine
Sponsored by
Klinicki Centar Vojvodine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gallstones focused on measuring gallstones, cholelithiasis, cholecystectomy, laparoscopic, pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Klinicki Centar Vojvodine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Multi-modal analgesia

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

nausea
Surgical outcome data recorded prospectively also included severity of post-operative nausea (measured VAS, 0 none and 10 worst state) on one and six hours post-operatively.

Full Information

First Posted
October 16, 2013
Last Updated
October 24, 2013
Sponsor
Klinicki Centar Vojvodine
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1. Study Identification

Unique Protocol Identification Number
NCT01972620
Brief Title
RCT: Multi-modal Analgesia for Laparoscopic Cholecystectomy
Acronym
LapChole
Official Title
Prospective Randomized Controlled Trial (PRCT) Comparing Standard Analgesia With Multi-modal Targeted Operative and Port-Site Local Anesthesia for Post-Operative Pain Management in Elective Laparoscopic Cholecystectomy (LapChole)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Klinicki Centar Vojvodine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Background: Peri-portal nerve stimulation has recently been suggested as a mechanism for pain after laparoscopic cholecystectomy (LapChole). We therefore conducted a PRCT to evaluate whether somatovisceral pain blockade reduces pain after LapChole. Hypothesis:Analgesic efficacy of multi-modal analgesia is superior to standard analgesia for patients undergoing elective LapChole for symptomatic cholelithiasis. Specifically, topical cystic plate and port-site infiltrationwith0.25% bupivacaine significantly reduces pain after LapChole. Design: Single-blinded PRCT Setting: Academic medical centers Patients and Methods: Between February and May 2010 we randomly assigned 63 patients with symptomatic cholelithiasis in a 1:1 ratio to institutional standard non-opioid/opioid analgesic combinations (n=32), and institutional standard analgesia plus topical 0.25%bupivacaine spray onto the cystic plate and local 0.25% bupivacaine port-site injection,post-LapChole (n=31). Primary endpoint was patient-reported pain 1, 4, 6, 12, and 24 hours, and 1 week post-LapCholeusing the Visual Acuity Score (VAS, 0-10). Results: Study groups were comparable clinicopathologically. There were no study-procedure-associated adverse events. A statistically significant reduction in mean pain score was apparent in patients receiving multi-modal analgesia at all early (1-6 hours) post-operative time points and at one week following LapChole(p<0.05). Conclusion: This PRCT shows significantly improved pain reduction with somatovisceral pain blockade than institutional standard analgesic combinations following LapChole for symptomatic cholelithiasis. For centers not utilizing adjunctive local anesthetic for this operation, this multi-modal analgesic approach can improve patient comfort during recovery.This approach serves as the basis for a planned 4-arm PRCT designed to provide further insights into the role of local anesthetics in multi-modal operative site analgesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallstones, Cholelithiasis, Pain
Keywords
gallstones, cholelithiasis, cholecystectomy, laparoscopic, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multi-modal analgesia
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine, Bupivacaine HCL
Intervention Description
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
Primary Outcome Measure Information:
Title
Visual Scale Pain VAS
Description
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).
Time Frame
from 0 to 7 postoperative days
Secondary Outcome Measure Information:
Title
nausea
Description
Surgical outcome data recorded prospectively also included severity of post-operative nausea (measured VAS, 0 none and 10 worst state) on one and six hours post-operatively.
Time Frame
from 0 to 6 hours post-operatively
Other Pre-specified Outcome Measures:
Title
mobility
Description
Surgical outcome data recorded prospectively also included hospital stay (days), impairment of mobility [measured with VAS, 0 is worst and 10 optimal mobility (pre-operative baseline)] one and seven days post-operatively,
Time Frame
from 0 to 7 postoperative days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: symptomatic cholelithiasis undergo elective laparoscopic cholecystectomy non - pregnant women 18 years or older Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Radovan Veljkovic, MD, PhD
Organizational Affiliation
Clinical Centre of Vojvodina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinicki Centar Vojvodine
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia

12. IPD Sharing Statement

Citations:
PubMed Identifier
16897291
Citation
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.
Results Reference
result
PubMed Identifier
16931681
Citation
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.
Results Reference
result
PubMed Identifier
22008277
Citation
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.
Results Reference
result
PubMed Identifier
15966498
Citation
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.
Results Reference
result

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RCT: Multi-modal Analgesia for Laparoscopic Cholecystectomy

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