Skip to content

Effect of Melatonin in relieving pain and Quality of Recovery following spine surgery when given preoperatively

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 - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/059763
Enrollment
66
Registered
2023-11-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G891- Acute pain, not elsewhere classified

Interventions

Intervention1: Group M (Melatonin): Interventional group (Group M) will be given Melatonin 6mg tablet Orally once daily at night 3 days prior to Surgery, 1 hour before surgery and on the night of su

Sponsors

AIIMS Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA I & II patients planned for elective spinal fusion surgery (one or two levels)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Time to request for 1st rescue analgesia in the postoperative periodTimepoint: 1st 24 hours after surgery

Secondary

MeasureTime frame
CRP and IL-6 levelsTimepoint: preoperative and 24 hours postoperative;QOR 15 ScoreTimepoint: preoperative and 24 hours postoperative;Total amount of analgesics (Intravenous Tramadol in milligrams)Timepoint: 1st 24 hours postoperatively;VAS ScoreTimepoint: 1 hour, 6 hour, 12 hour, 24 hour postoperatively

Countries

India

Contacts

Public ContactDr Aparajita Panda

AIIMS Bhubaneswar

anaes_aparajita@aiimsbhubaneswar.edu.in9438884118

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026