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
|Condition or disease||Intervention/treatment||Phase|
|Cholecystitis Gall Stone Pancreatitis||Drug: Bupivacaine Other: Normal saline||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
0.25% 20ml administered intraperitoneal
Other Name: Marcaine
- VAS pain score
- VRS pain score
- Satisfaction score (VAS)
- Physiological observations - respiratory rate, oxygen saturation
- Analgesic use post operation
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
|University Hospitals Coventry and Warwickshire|
|Coventry, Warwickshire, United Kingdom, CV2 2DX|