drugset / Trial / NCT07425678

Comparison of Systemic Opioid (Morphine) and Pre-Incision Bilateral Scalp Nerve Block for Pain Management in Craniotomy Patients

NCT07425678

Phase 4 Completed 62 enrolled Aga Khan University
RandomizedParallel-groupDouble-blindSupportive care

Summary

The goal of this randomized controlled clinical trial is to compare the effectiveness of systemic opioids versus pre-incision bilateral scalp nerve block in managing intraoperative noxious stimuli and postoperative pain in adult patients (18-75 years) undergoing elective supratentorial craniotomy. The main questions this study aims to answer are: Does pre-incision bilateral scalp nerve block provide better intraoperative hemodynamic stability compared to systemic opioids? Does it result in lower postoperative pain scores and reduced opioid consumption during the first 24 hours after surgery? Researchers will compare Group M (systemic morphine) with Group S (bilateral scalp nerve block) to see if the scalp nerve block offers superior analgesia and fewer opioid-related side effects. Participants will: Be randomly assigned to receive either systemic morphine or bilateral scalp nerve block before incision. Undergo standard general anesthesia for craniotomy. Have postoperative pain managed using a patient-controlled analgesia (PCA) morphine pump and be monitored for 24 hours for pain, sedation, and nausea/vomiting scores

Timeline

Start
2025-01-01
Primary completion
2025-07-01
Completion
2025-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 4 mg Other
Subject Epinephrine Other / unclassified Other
Subject Lidocaine Other / unclassified 0.1 % Other
Comparator Morphine Other / unclassified 0.1 mg/kg Intravenous
Subject Ropivacaine Other / unclassified 0.25 % Other

Indications