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Clinical Trials/CTRI/2024/03/063857
CTRI/2024/03/063857
Not yet recruiting
Phase 3 4

A RANDOMIZED DOUBLE BLINDED COMPARITIVE STUDY OF INSTILLATION OF BUPRENORPHINE VS PLACEBO IN EPIDURAL SPACE FOR POSTOPERATIVE ANALGESIA IN POST LAMINECTOMY PATIENTS

Department of Anaesthesiology1 site in 1 country40 target enrollmentStarted: March 20, 2024Last updated:

Overview

Phase
Phase 3 4
Status
Not yet recruiting
Sponsor
Department of Anaesthesiology
Enrollment
40
Locations
1
Primary Endpoint
Pain by Numerical pain rating scale

Overview

Brief Summary

Immediate postoperative pain relief after surgery can significantly affect the outcome of surgical procedures and operative morbidity. Parenteral opioids are the mainstay of treatment for postoperative pain after laminectomy. But these are usually given with large time lapses which cause fluctuations in clinical effect. The epidural injection of opioids has proven to be effective and has a longer duration of action in relieving postoperative pain. Postoperative pain management for spinal surgery with epidural infusion of morphine and fentanyl has been widely reported. Buprenorphine, because it is more potent and more lipid-soluble and has a longer duration of action, is said to have advantages over morphine for epidural use in postoperative pain relief.

Study Design

Study Type
Interventional
Allocation
Randomized

Eligibility Criteria

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

Inclusion Criteria

  • Patients willing to give informed and written consent ASA physical status I & II Patients with body weight 50-80kgs.

Exclusion Criteria

  • ASA physical status III and above.
  • Patients who have known hypersensitivity to the study drugs Patients with history of neuromuscular disease Patients with history of substance abuse.

Outcomes

Primary Outcomes

Pain by Numerical pain rating scale

Time Frame: 1st, 2nd, 3rd, 4th, 5th, 6th, 12th, 18th and 24 hours

Secondary Outcomes

  • Pulse Rate(Mean Arterial Pressure)

Investigators

Sponsor
Department of Anaesthesiology
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Yoganarasimha N

BGS Global Institute of Medical Sciences

Study Sites (1)

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