Efficacy of Pre-emptive Different Doses of Oral Pregabalin Versus Celecoxib on Sevoflurane and Analgesic Consumption in Patients Subjected for Elective Lumbar Spine Fixation Surgery: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- pain control
Study Overview
Brief Summary
The anti-epileptic drugs such as gabapentin and other non-steroidal anti-inflammatory drugs (NSAID) such as celecoxib were used as a part of multimodal analgesia to control such pain. Gabapentin is an anticonvulsant drug that has analgesic effect in post-herpetic neuralgia, diabetic neuropathy, and neuropathic pain. Celecoxib is one of the NSAIDs, that its analgesic effect is reported in various studies by cyclooxygenase-2 (COX-2) inhibitor.
The aim of this randomized double-blinded study was to asses and compare the efficacy of using gabapentin versus celecoxib as a part of multimodal analgesia in perioperative hemodynamic control and pain relief in patients underwent posterior approach lumbar spine disc fixation surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 21 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •American society of anesthesiologists (ASA) I and II, aged between 21-60 years old scheduled to undergo elective posterior approach lumbar spine disc surgery
Exclusion Criteria
- •Patients with a known sensitivity to celecoxib or pregabalin, psychotic disorder or cognitive impairment, history of drug dependency or substance addiction, history of chronic medical disease, the presence of coagulation disorders or pregnancy, were excluded from the study.
Arms & Interventions
Group (C)
received celecoxib 200 mg 2 hours preoperative and the same dose 6 hours postoperative.
Intervention: Celecoxib capsules (Drug)
Group (G)
received gabapentin 300 mg capsule 2 hours preoperative and the same dose 6 hours postoperative.
Intervention: Pregabalin 150mg (Drug)
Outcomes
Primary Outcomes
pain control
Time Frame: Change from Baseline Visual Analogue Scale every 4 hours for 48 hours (0=no pain 10=most sever pain)
Visual Analogue Scale for pain measurement.
Secondary Outcomes
No secondary outcomes reported
Investigators
Alaa Ali M. Elzohry
Lecturer of Anesthesia, ICU and Pain Relief
Clinical Research Consultants, Inc.