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Randomized Control Trial of Intraperitoneal Bupivacaine During Cholecystectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 4, 2012
First Posted Date  ICMJE February 8, 2012
Last Update Posted Date February 8, 2012
Study Start Date  ICMJE January 2009
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2012)
VAS pain score
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2012)
  • VRS pain score
  • Satisfaction score (VAS)
  • Physiological observations - respiratory rate, oxygen saturation
  • Analgesic use post operation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Control Trial of Intraperitoneal Bupivacaine During Cholecystectomy
Official Title  ICMJE Double Blind Sham Controlled Randomised Trial of Intraperitoneal Bupivacaine During Acute Laparoscopic Cholecystectomy
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cholecystitis
  • Gall Stone Pancreatitis
Intervention  ICMJE
  • Drug: Bupivacaine
    0.25% 20ml administered intraperitoneal
    Other Name: Marcaine
  • Other: Normal saline
    sodium chloride 0.9% solution
Study Arms  ICMJE
  • Sham Comparator: Saline sham injection
    Sham wash and injection with normal saline (09%)
    Intervention: Other: Normal saline
  • Active Comparator: Bupivacaine
    Bupivacaine injection/wash treatment arm
    Intervention: Drug: Bupivacaine
Publications * Roberts KJ, Gilmour J, Pande R, Hodson J, Lam FT, Khan S. Double-blind randomized sham controlled trial of intraperitoneal bupivacaine during emergency laparoscopic cholecystectomy. Hepatobiliary Pancreat Dis Int. 2013 Jun;12(3):310-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2012)
42
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients undergoing emergency cholecystectomy for cholecystitis or gall stone pancreatitis

Exclusion Criteria:

  • patients undergoing planned elective cholecystectomy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01528722
Other Study ID Numbers  ICMJE Acute lap chole RCT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Keith Roberts, University Hospitals Coventry and Warwickshire NHS Trust
Study Sponsor  ICMJE University Hospitals Coventry and Warwickshire NHS Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospitals Coventry and Warwickshire NHS Trust
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP