Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomy, a double-blind, placebo-controlled trial

Background
This study evaluated the efficacy of transdermal fentanyl (TDF) delivery system (50 μg/h) or transdermal melatonin (TDM) delivery system (7 mg) 2 h preoperatively for acute postoperative pain after lumbar laminectomy compared to placebo group (C).
Methods
Seventy-five patients of both sexes, aged 18–50 years, ASA I and II undergoing elective single level lumber laminectomy under general anesthesia were included in this randomized controlled double-blind study. Patients were randomly divided into 3 groups 25 each, C group patients received transdermal placebo patch, TDF group (50 μg/h) and TDM group (7 mg). Assessment of postoperative pain, sedation, hemodynamic variables such as HR and MAP, postoperative monitoring of arterial SpO and side effects (e.g. nausea, vomiting, pruritis, respiratory depression and hemodynamic instability) was done 30 min, 1, 2, 6 and 12 h postoperatively. Postoperative Patient‘s and Surgeons‘ satisfaction, Intraoperative bleeding and plasma cortisol (μg/dl) postoperatively were also assessed.
Results
There was a significant reduction in the VAS score, total pethidine requirements and significantly higher Patient‘s satisfaction in TDF and TDM groups when compared with the C group 6 h postoperatively. The sedation score and Surgeons‘ satisfaction were significantly higher associated with a significant decrease in MAP and Intraoperative bleeding in TDM group compared to groups C and TDF 6 h postoperatively. Significant nausea and vomiting in TDF group and significant sedation in TDM group were recorded.
Conclusion
The use of preoperative TDF 50 μg/h or TDM 7 mg was an effective and a safe adjuvant for acute pain after surgery.