Health Condition 1: M489- Spondylopathy, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: American Society of Anaesthesiologists (ASA) grade I-II patients undergoing elective lumbosacral spinal fixation surgery (non traumatic spondylopathy) involving two or more levels.
Exclusion criteria
Exclusion criteria: Patient refusal Patient with known hypersensitivity to either drug Patient with neuromuscular disease like Myasthenia Gravis Patients already on Capsule Gabapentin Pregnancy Patients with pre-existing significant cardiac, respiratory, hepatic, renal disease Patients lost to/not willing to follow up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-operative pain assessment using Numeric Rating Scale for surgical site pain and leg pain (radiculopathy)(NRS)Timepoint: At regular intervals during first 24 hour postoperatively | — |
Secondary
| Measure | Time frame |
|---|---|
| Opioid consumptionTimepoint: During surgery and in the first 24 hours after surgery;time for Requirement of first rescue analgesiaTimepoint: In the first 24 hours after surgery;Adverse effects of study drugs if anyTimepoint: Immediate and delayed;Time taken for first ambulationTimepoint: After surgery (in hours);Number of hospitalisation daysTimepoint: Post-operative days;Quality of life assessment using EuroQoL questionnaireTimepoint: At the time of hospital discharge and 30 days follow up using EuroQoL questionnaire;Intra-operative haemodynamic changesTimepoint: During the surgery at regular intervals | — |
Countries
India
Contacts
All India Institute of Medical Sciences (AIIMS), Rishikesh