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Randomized Control Trial of Intraperitoneal Bupivacaine During Cholecystectomy

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ClinicalTrials.gov Identifier: NCT01528722
Recruitment Status : Completed
First Posted : February 8, 2012
Last Update Posted : February 8, 2012
Sponsor:
Information provided by (Responsible Party):
Keith Roberts, University Hospitals Coventry and Warwickshire NHS Trust

Brief Summary:
Laparoscopic cholecystectomy (removal of the gall bladder via 'keyhole surgery') is a common procedure. This can be performed as an emergency operation when a patient has a complication of gall stones such as acute inflammation or pancreatitis. There are several trials which demonstrate that placing local anaesthetic inside the abdomen at the site of gall bladder surgery during a planned elective operation decreases post operative pain. This is the first trial to investigate the efficacy of this local anaesthetic during emergency cholecystectomy.

Condition or disease Intervention/treatment Phase
Cholecystitis Gall Stone Pancreatitis Drug: Bupivacaine Other: Normal saline Not Applicable

Detailed Description:

Background Several studies, including a metanalysis, have demonstrated that intraperitoneal local anaesthetic (IP LA) during elective laparoscopic cholecystectomy (el-LC) decreases post operative pain. None have explored the efficacy of IP LA at emergency laparoscopic cholecystectomy (em-LC). A longer operation duration, greater frequency of washing and the inflammation associated with cholecystitis or pancreatitis are a few reasons why it cannot be assumed that a benefit in pain scores will be seen in em-LC with IP LA. This study assesses the efficacy of IP LA used in patients undergoing em-LC.

Methods Double blind randomised sham controlled trial of 42 consecutive subjects undergoing em- LC.

IP-LA was delivered by a combination of direct injection to the diaphragmatic and topical wash over the liver/gall bladder with bupivacaine or sham depending upon allocation. The primary outcome was VAS pain scores on the ward. Secondary outcomes included VRS pain scores in theatre recovery, analgesic use, physiological observations, time to eating and ambulation and length of postoperative stay.

Results One patient had a procedure converted to open and was excluded. There was no significant difference in pain scores on the ward or in theatre recovery. Analgesic use, respiratory rate, oxygen saturation, duration to ambulation, eating, satisfaction scores and time to discharge were comparable between the groups.

Conclusions Intraperitoneal LA during em-LC does not influence post-operative pain. Other modalities of analgesia should be explored as well as decreasing the interval between diagnosis of acute admission and em-LC.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double Blind Sham Controlled Randomised Trial of Intraperitoneal Bupivacaine During Acute Laparoscopic Cholecystectomy
Study Start Date : January 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010


Arm Intervention/treatment
Sham Comparator: Saline sham injection
Sham wash and injection with normal saline (09%)
Other: Normal saline
sodium chloride 0.9% solution
Active Comparator: Bupivacaine
Bupivacaine injection/wash treatment arm
Drug: Bupivacaine
0.25% 20ml administered intraperitoneal
Other Name: Marcaine



Primary Outcome Measures :
  1. VAS pain score

Secondary Outcome Measures :
  1. VRS pain score
  2. Satisfaction score (VAS)
  3. Physiological observations - respiratory rate, oxygen saturation
  4. Analgesic use post operation


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

Inclusion Criteria:

  • patients undergoing emergency cholecystectomy for cholecystitis or gall stone pancreatitis

Exclusion Criteria:

  • patients undergoing planned elective cholecystectomy

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): NCT01528722


Locations
United Kingdom
University Hospitals Coventry and Warwickshire
Coventry, Warwickshire, United Kingdom, CV2 2DX
Sponsors and Collaborators
University Hospitals Coventry and Warwickshire NHS Trust

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Keith Roberts, Mr, University Hospitals Coventry and Warwickshire NHS Trust
ClinicalTrials.gov Identifier: NCT01528722     History of Changes
Other Study ID Numbers: Acute lap chole RCT
First Posted: February 8, 2012    Key Record Dates
Last Update Posted: February 8, 2012
Last Verified: February 2012

Keywords provided by Keith Roberts, University Hospitals Coventry and Warwickshire NHS Trust:
Emergency laparoscopic cholecystectomy
Pain scores
Intraperitoneal local anaesthesia
Cholecystitis

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