Randomized Control Trial of Intraperitoneal Bupivacaine During Cholecystectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Keith Roberts, University Hospitals Coventry and Warwickshire NHS Trust
ClinicalTrials.gov Identifier:
NCT01528722
First received: February 4, 2012
Last updated: February 7, 2012
Last verified: February 2012
  Purpose

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 Intervention
Cholecystitis
Gall Stone Pancreatitis
Drug: Bupivacaine
Other: Normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double Blind Sham Controlled Randomised Trial of Intraperitoneal Bupivacaine During Acute Laparoscopic Cholecystectomy

Resource links provided by NLM:


Further study details as provided by University Hospitals Coventry and Warwickshire NHS Trust:

Primary Outcome Measures:
  • VAS pain score [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • VRS pain score [ Designated as safety issue: No ]
  • Satisfaction score (VAS) [ Designated as safety issue: No ]
  • Physiological observations - respiratory rate, oxygen saturation [ Designated as safety issue: No ]
  • Analgesic use post operation [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: January 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing emergency cholecystectomy for cholecystitis or gall stone pancreatitis

Exclusion Criteria:

  • patients undergoing planned elective cholecystectomy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by University Hospitals Coventry and Warwickshire NHS Trust

Additional 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
Study First Received: February 4, 2012
Last Updated: February 7, 2012
Health Authority: United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Acalculous Cholecystitis
Cholecystitis
Pancreatitis
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Pancreatic Diseases
Bupivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014