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Clinical Trials/CTRI/2022/08/044612
CTRI/2022/08/044612Not yet recruitingNot Applicable

Comparative study of Tramadol and Buprenorphine Transdermal patch for postoperative analgesia in Nephrectomy surgery.

Mahatma Gandhi Medical College1 site in 1 country60 target enrollmentStarted: January 9, 2022Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
To compare Analgesic effect postoperatively between Tramadol and Transdermal Buprenorphine patch in Nephrectomy patients.

Study Overview

Brief Summary

Postoperative pain is a majorconcern for patients undergoing Nephrectomy surgery. Pain can be associatedwith adverse physiological and psychological effects hampering the normalrecovery process. Preventive analgesia, initiated beforethe surgical procedure, can theoretically reduce pain sensitization, butmultiple clinical studies have failed to demonstrate convincing clinicalbenefit.

Buprenorphine, a derivative ofthe opium alkaloid thebaine, is a more potent and longer lasting analgesic. Itsdissociation from opioid receptor binding is slow which probably accounts forits longer duration of action. The lack of delta receptor agonist activity maybe responsible for the observation that buprenorphine is less likely to inducetolerance on chronic use.

Buprenorphine is usedclinically for the treatment of moderate-to-severe pain, includingperioperative analgesia. A transdermal patch formulation of buprenorphinehas recently been introduced in the Indian market. Although expensive, thismode of delivery has several potential benefits over oral and parenteraladministration. These include noninvasive dosing, betterabsorption, lack of first-pass metabolism, and steady plasma concentration. Thebuprenorphine patch releases the analgesic steadily over 7 days and has beensuccessfully used to treat a variety of chronic pain conditions. However,there is limited clinical experience of its utility in postoperative pain.

  Tramadol is a centrally acting analgesic with weak opioidagonist. Its safety is well established by the fact that the clinicallyrelevant respiratory depression is not seen with tramadol and it has lowdependence and abuse potential. All these properties make tramadol as the idealdrug for the management of post-operative pain. Hence, tramadol is one of themost commonly used analgesics in post-operative period. Tramadol has goodbioavailability (70%–90%); hence, it has been used for providing post-operativeanalgesia. It should be used cautiously in patients with renal failure due torisk of accumulation.

Study Design

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

Eligibility Criteria

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

Inclusion Criteria

  • ASA Grade I/II Patient UnderGoing Nephrectomy Surgery Patient Written And Informed Consent.

Exclusion Criteria

  • Allergy to Study Drug ASA Grade III/IV.

Outcomes

Primary Outcomes

To compare Analgesic effect postoperatively between Tramadol and Transdermal Buprenorphine patch in Nephrectomy patients.

Time Frame: 5-7 days

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Mahatma Gandhi Medical College
Sponsor Class
Private medical college

Study Sites (1)

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