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Clinical Trials/CTRI/2016/12/007577
CTRI/2016/12/007577CompletedNot Applicable

Comparison of analgesic efficacy ofepidural analgesia with continuous transversusabdominis plane block in renal transplant recipients

PGIMER1 site in 1 country62 target enrollmentStarted: January 8, 2014Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
PGIMER
Enrollment
62
Locations
1
Primary Endpoint
Numerical Pain rating scale score postoperatively

Study Overview

Brief Summary

Although continuous TAPblock has been compared with epidural analgesia in laparoscopic surgeries, tothe best of our knowledge a study directly comparing the technique withepidural analgesia has not been performed in renal transplantrecipients. The existing study was designed to directly comparecontinuous TAP block with continuous patient controlled epidural blockade todetermine whether TAP block can provide a useful alternative to epiduralanalgesia in this subset of patients.

The studyhypothesizes that transversus abdominis plane block is a non inferior analgesictechnique to continuous epidural analgesia in renal transplant recipients.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant Blinded

Eligibility Criteria

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

Inclusion Criteria

  • Patients with end stage renal disease scheduled to undergo live donor renal transplant.

Exclusion Criteria

  • 1.Refusal to give consent.
  • 2.Derangements of coagulation profile contraindicating the use of epidural anaesthesia (INR of ≥1.3 will be considered a cut-off for the study).
  • 3.Addiction to opioids, or alcohol, or history of any other substance abuse.
  • 4.Allergy to local anaesthetic drugs.
  • 5.Extension of surgical incision lateral to anterior axillary line or above T8 dermatome.
  • 6.Inability to communicate (e.g. known psychiatric disorders).
  • 7.Accidental complications such as dural puncture or peritoneal breach.

Outcomes

Primary Outcomes

Numerical Pain rating scale score postoperatively

Time Frame: Numerical Pain rating scale score at 0, 1, 2, 4, 6, 12, 24 hours postoperatively

Secondary Outcomes

  • Requirement of postoperative opioid (fentanyl) in the first 24 hours postoperatively(24 hours postoperatively)
  • Patient satisfaction with the analgesia regimen.(24 hours postoperatively)

Investigators

Sponsor
PGIMER
Sponsor Class
Research institution and hospital

Study Sites (1)

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