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Clinical Trials/CTRI/2019/02/017802
CTRI/2019/02/017802Not yet recruitingNot Applicable

Efficacy of high-volume low- concentration intraperitoneal bupivacaine irrigation for post operative analgesia in patients undergoing laparoscopic cholecystectomy

SWATI PANWAR1 site in 1 country30 target enrollmentStarted: February 28, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
DURATION OF ANALGESIA

Study Overview

Brief Summary

Effective post operative analgesia after laparoscopic cholecystectomy remains a clinical challenge. Recently, instillation of different local anaesthetics (LAs) intraperitoneally has gained popularity for post-operative analgesia in laparoscopic cholecystectomy. Most of the studies have used bupivacaine irrigation of peritoneal cavity in low volume(20ml to 100ml) and high concentration(0.125%-0.5%). However, their analgesic action is effective for only a few hours in the post-operative period.

Recently low concentration(0.02%)  but high volume (500 ml) of bupivacaine has been used for intraperitoneal irrigation in order to cover large sub hepatic area and surrounding peritoneum thereby producing more effective analgesia. It significantly increased duration of analgesia and reduced opioid requirement after laparoscopic cholecystectomy.

Study Design

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

Eligibility Criteria

Ages
20.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •ASA PHYSICAL STATUS I/II
  • •SCHEDULED FOR ELECTIVE LAPAROSCOPIC CHOLECYSTECTOMY UNDER GENERAL ANAESTHESIA.

Exclusion Criteria

  • •ALLERGY TO LOCAL ANAESTHETICS
  • •ACUTE PANCREATITIS
  • •CHOLEDOCHOLITHIASIS
  • •CURRENT ANALGESIC USE
  • •INABILITY TO COMPREHEND NRS( NUMERIC PAIN RATING SCALE) 6.

Outcomes

Primary Outcomes

DURATION OF ANALGESIA

Time Frame: time interval between removal of airway device and first requirement of rescue analgesic

Secondary Outcomes

  • -NUMERIC PAIN RATING SCALE(-TOTAL DOSE OF RESCUE)

Investigators

Sponsor
SWATI PANWAR
Sponsor Class
Other [self]

Study Sites (1)

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