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Clinical Trials/CTRI/2019/08/020573
CTRI/2019/08/020573CompletedNot Applicable

A study comparing the analgesic efficacy of single dose of epidural morphine Vs epidural morphine with ketamine in patients undergoing lumbar laminectomy with or without discectomy - A randomized controlled clinical trial

Institutional Review Board1 site in 1 country50 target enrollmentStarted: October 8, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
Time Taken to Receive First Rescue Analgesia

Study Overview

Brief Summary

post operative pain is an important factor that affects recovery after surgery , epidural administration of opioids have been proven to be effective in managing post OP pain . epidural administration of NMDA antagonist has been shown to prolong post OP analgesic and reduce opioid induced central centralization of pain , prevent opioid induced hyperalgesia and opioid tolerance . in this study we are comparing administration of epidural morphine and epidural morphine with  ketamine to know which provide better analgesia in post OP lumbar laminectomy patients - in terms of time to receive rescue analgesia , total amount of rescue analgesic received . improves NRS scale .

Study Design

Study Type
Interventional
Allocation
Stratified block randomization
Masking
Participant, Investigator and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •ASA I AND II
  • •Patients Undergoing Lumbar Laminectomy And Discectomy Surgery
  • •Normal Renal Functions.

Exclusion Criteria

  • •ASA III OR IV
  • •Impaired Renal Function
  • •Intraoperative CSF Leak
  • •Any Contraindications to Morphine and Ketamine.

Outcomes

Primary Outcomes

Time Taken to Receive First Rescue Analgesia

Time Frame: 3 Hours

Secondary Outcomes

  • 1. NRS score 1-10(2. Total Amount of Rescue Analgesic Consumed: Cumulative opioid Consumption)

Investigators

Sponsor Class
Private medical college

Study Sites (1)

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