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

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ClinicalTrials.gov Identifier: NCT01972620
Recruitment Status : Completed
First Posted : October 30, 2013
Last Update Posted : October 30, 2013
Sponsor:
Information provided by (Responsible Party):
Radovan Veljkovic, M.D., Ph.D., Klinicki Centar Vojvodine

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.

Condition or disease Intervention/treatment Phase
Gallstones Cholelithiasis Pain Drug: Bupivacaine Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : February 2010
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Multi-modal analgesia
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
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
Other Names:
  • Marcaine
  • Bupivacaine HCL

No Intervention: Control
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.



Primary Outcome Measures :
  1. Visual Scale Pain VAS [ Time Frame: from 0 to 7 postoperative days ]
    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 :
  1. nausea [ Time Frame: from 0 to 6 hours post-operatively ]
    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.


Other Outcome Measures:
  1. mobility [ Time Frame: from 0 to 7 postoperative days ]
    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,



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972620


Locations
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Serbia
Klinicki Centar Vojvodine
Novi Sad, Vojvodina, Serbia, 21000
Sponsors and Collaborators
Klinicki Centar Vojvodine
Investigators
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Principal Investigator: Radovan Veljkovic, MD, PhD Clinical Centre of Vojvodina

Publications of Results:
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Responsible Party: Radovan Veljkovic, M.D., Ph.D., MD, PhD, ass. prof, Klinicki Centar Vojvodine
ClinicalTrials.gov Identifier: NCT01972620     History of Changes
Other Study ID Numbers: 00-01/515
First Posted: October 30, 2013    Key Record Dates
Last Update Posted: October 30, 2013
Last Verified: October 2013

Keywords provided by Radovan Veljkovic, M.D., Ph.D., Klinicki Centar Vojvodine:
gallstones
cholelithiasis
cholecystectomy, laparoscopic
pain

Additional relevant MeSH terms:
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Gallstones
Cholelithiasis
Cholecystolithiasis
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents