Role Of Pregabalin To Decrease Postoperative Pain In Microdiscectomy

Phase 4

Completed

• Conditions: Pain, Nerve; Prolapsed Intervertebral Disc
• Interventions: Device: Placebo; Drug: Pregabalin 75mg

• Registration Number: NCT04653792
• Lead Sponsor: Ziauddin University

Brief Summary

The purpose of this study is to compare the effect of pregabalin in reducing the neuropathic pain in postoperative patients who have undergone single level Microdiscectomy for prolapsed intervetebral lumbar disc.

Detailed Description

All patients were informed in detailed regarding the risk and complications and given written and informed consent, coming to our clinics were assessed by one of the senior team members of the spine, patient fulfilling the eligibility criteria were selected and included in the study. One week before the surgery the patients who met the eligibility criteria were randomized in a double-blind manner (participant and investigator) in a ratio of 1:1 into Group-A (Pregabalin 7mg, twice daily) or Group-B (Placebo, twice daily). The pain scores were recorded by VAS and Roland Morris score system on preoperative day compared to the scores on the 1st week postoperative follow-up.

Study Timeline

• Study Start: 2018-06-04
• Primary Completion: 2020-04-17
• Study Completion: 2020-04-17
• Study First Submitted: 2020-11-27
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-03
• Last Update Submitted: 2020-12-03
• Study First Posted: 2020-12-04
• Last Update Posted: 2020-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• All patients with severe CLBP and/or leg pain
• Patients with static or dynamic leg pain
• Patients with leg pain resulting from localized lumbar or lumbosacral segmental instability
• Spinal stenosis at levels L2-S1 or caused by isthmic spondylolisthesis (grade I and II)

Exclusion Criteria

• Patients with previous lumbar surgery
• Patients allergic to gabapentinoids
• Patients with renal impairments
• Patients who are already on opioids, benzodiazepines, barbiturates, ethanol (alcohol)
• Patient presented with diabetes and other drugs that depress the central nervous system
• Patients who are already on ACE inhibitors as they may enhance the adverse/toxic effect of Pregabalin.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pregabalin Placebo	Placebo	Participants received Pregabalin placebo capsule matching Pregabalin twice daily from preoperative day to 1 week postoperative
Pregabalin	Pregabalin 75mg	Participants received Pregabalin 75mg capsule twice daily from preoperative day to 1 week postoperative

Primary Outcome Measures

Name	Time	Method
change from preoperative pain score using a 10 point visual analog scale (VAS pain scale) at 1 week post surgery for PID	Preoperative and one week postoperative	VAS pain scale is a validated, self-reported instrument assessing average pain intensity over the past 24 hours period. Possible scores being 0 (no pain) and 10 (worst possible pain). Change = (1 week post surgery - preoperative pain)

Trial Locations

Locations (1)

Dr. Ziauddin University Hospital Clifton Campus; 🇵🇰 Karachi, Sindh, Pakistan