Effect of Preoperative Melatonin on Postoperative pain relief and Quality of Recovery in patients undergoing spinal fusion surgery: A randomised, triple-blinded, placebo-controlled trial
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- AIIMS Bhubaneswar
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Time to request for 1st rescue analgesia in the postoperative period
Overview
Brief Summary
Postoperative pain plays a significant role in the recovery of patients as it can lead to patient discomfort and increase the duration of hospital stay. Pain and anxiety positively interact with each other. Opioids and NSAIDs are most commonly used for postoperative pain relief, leading to several undesirable side effects. Earlier studies have demonstrated the analgesic action of Melatonin in various surgeries without unwanted side effects. It also has a role in improving the Quality of Recovery. To the best of our knowledge, no studies have demonstrated the analgesic properties of Melatonin in spinal fusion surgery. So, we hypothesize that Melatonin will be effective in relieving Postoperative pain and Quality of Recovery in spinal fusion surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ASA I & II patients planned for elective spinal fusion surgery (one or two levels).
Exclusion Criteria
- •Refusal to give consent, Spinal fusion surgery involving cervical spine and at different sites, Allergy to Melatonin, Pregnancy, BMI > 30kg/m2, Use of narcotic painkillers, gabapentin and tricyclic antipsychotics 72 hours before the intervention, history of any psychiatric disorder, chronic hepatic or renal disorder.
Outcomes
Primary Outcomes
Time to request for 1st rescue analgesia in the postoperative period
Time Frame: 1st 24 hours after surgery
Secondary Outcomes
- VAS Score(1 hour, 6 hour, 12 hour, 24 hour postoperatively)
- Total amount of analgesics (Intravenous Tramadol in milligrams)(1st 24 hours postoperatively)
- QOR 15 Score(preoperative and 24 hours postoperative)
- CRP and IL-6 levels(preoperative and 24 hours postoperative)
Investigators
Dr Ananya Ray
AIIMS Bhubaneswar