Randomized Control Trial of Intraperitoneal Bupivacaine During Cholecystectomy

Brief Title

Randomized Control Trial of Intraperitoneal Bupivacaine During Cholecystectomy

Official Title

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

Interventional

Primary Outcome

VAS pain score

Secondary Outcome

 VRS pain score

Condition

Cholecystitis

Intervention

Bupivacaine

Study Arms / Comparison Groups

 Saline sham injection

Description:  Sham wash and injection with normal saline (09%)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

42

Start Date

January 2009

Completion Date

January 2010

Primary Completion Date

January 2010

Eligibility Criteria

        Inclusion Criteria:

          -  patients undergoing emergency cholecystectomy for cholecystitis or gall stone
             pancreatitis

        Exclusion Criteria:

          -  patients undergoing planned elective cholecystectomy
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

NCT ID

NCT01528722

Organization ID

Acute lap chole RCT

Responsible Party

Principal Investigator

Study Sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Study Sponsor

, , 

Verification Date

February 2012