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Clinical Trials/CTRI/2013/07/003825
CTRI/2013/07/003825CompletedPhase 4

A RANDOMISED CONTROLLED TRIAL COMPARING THE EFFICACY OF BUPIVACAINE AND ROPIVACAINE IN ULTRASOUND GUIDED TRANSVERSUS ABDOMINIS PLANE (TAP) BLOCK FOR POSTOPERATIVE ANALGESIA IN LAPAROSCOPIC CHOLECYSTECTOMY

Government Medical College and Hospital sector B chandigarh1 site in 1 country60 target enrollmentStarted: February 2, 2010Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
To Assess relative efficacy of ropivacaine and bupivacaine for post operative analgesia using ultrasound guided TAP block in patients undergoing Laparoscopic cholecystectomy

Study Overview

Brief Summary

Background :Ttransversus abdominis plane (TAP) block is a regional analgesic technique that blocks abdominal neural afferents by introducing local anaesthetic into the neurofascial plane between internal oblique and the transversus abdominis muscles thereby reducing the post operative pain of abdominal surgeries.

Method :  We evaluated the relative efficacy of bupivacaine 0.25% and ropivacaine 0.375% in ultrasound guided TAP block for postoperative analgesia in laparoscopic cholecystectomy. 60 adult ASA I & II patients undergoing elective laparoscopic cholecystectomy were randomized using computer coded sealed envelope to recieve either USG TAP block with 0.25% bupivacaine or 0.375% ropivacaine at the end of surgical procedure prior to extubation. All patients were assessed for postoperative pain, nausea vomiting and rescue analgesic consumption for upto 24 hours in the postoperative period.

Result : patients receiving USG TAP block with ropivacaine had significantly lower visual analog scale pain scores at 10 min, 30 min and 1 hour as compared to patients receiving USG TAP block with bupivacaine. beyond that both drugs are equal in their efficacy with respect to postoperative analgesia and 24 hrs cumulative rescue analgesic requirement. there were no complications attributable to TAP block.

Conclusion : USG TAP block is an effective regional analgesic technique for postoperative pain relief in patients undergoing laparoscopic cholecystectomy. ropivacaine has early onset of analgesia and provides better quality of pain relief in the immediate postoperative period upto 1 hour in comparison to bupivacaine. thereafter, both the drugs are equal in their efficacy in terms of postoperative analgesia and 24 gours cumulative rescue analgesic requirement.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant, Investigator and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •75 kg BW, Physical status ASA I and II.

Exclusion Criteria

  • •pregnancy, drug allergy, drug abuse, Conversion to open Cholecystectomy, mentally unstable patient, coagulation abnormality, patients with abdominal drain in situ.

Outcomes

Primary Outcomes

To Assess relative efficacy of ropivacaine and bupivacaine for post operative analgesia using ultrasound guided TAP block in patients undergoing Laparoscopic cholecystectomy

Time Frame: 10 min, 30 mins, 1 hr, 4 hrs, 8hrs, 12hrs and 24 hours

Secondary Outcomes

  • Assess post opeartive Nausea and vomiting, Calculate total rescue analgesic and antiemetic used(24hrs)

Investigators

Sponsor
Government Medical College and Hospital sector B chandigarh
Sponsor Class
Government medical college

Study Sites (1)

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