Comparison of two different drug effect for postoperative analgesia in Nephrectomy surgery.

Not yet recruiting

• Conditions: Medical and Surgical, (2) ICD-10 Condition: N29||Other disorders of kidney and ureter in diseases classified elsewhere,

• Registration Number: CTRI/2022/08/044612
• Lead Sponsor: Mahatma Gandhi Medical College

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-09
• Last Update Posted: 2022-07-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare Analgesic effect postoperatively between Tramadol and Transdermal Buprenorphine patch in Nephrectomy patients.	5-7 days

Trial Locations

Locations (1)

Mahatma Gandhi Medical College and Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Mahatma Gandhi Medical College and Hospital

🇮🇳Jaipur, RAJASTHAN, India

Dr Prakash Gangwani

Principal investigator

9408936833

prakashgangwani54@gmail.com