Intravenous Lignocaine for Pain Management in Adolescent Idiopathic Scoliosis Surgery

Unknown Phase 4 NCT04931433

Study Description

This study examines the use of intravenous Lignocaine as an analgesic adjunct for reducing morphine usage during the postoperative period in adolescent idiopathic scoliosis (AIS) patients undergoing posterior spinal fusion (PSF) surgery. The trial will be a double-blinded, randomized placebo-controlled trial. Participants will be randomized into two groups, Group A receiving Lignocaine and Group B receiving a saline placebo. The study design includes detailed protocols for dosing and administration, patient monitoring, and postoperative analgesia management. The primary outcome of the study will be postoperative morphine consumption at 24 hours, and Propofol requirements between the groups. The study includes measurements of plasma concentration levels of Lignocaine at various intervals after bolus injection. Data analysis will employ independent t-test, Mann Whitney U test, Chi square test, and Mixed analysis of variance (ANOVA) to determine the interaction between the two groups and time.}

Study Details

Registry ID:
NCT04931433
Conditions:
Adolescent Idiopathic Scoliosis, Analgesia
Phase:
Phase 4
Target Enrollment:
115 participants
Start Date:
Age Range:
10–18 years
Healthy Volunteers:
No

Study Locations (1 site)

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