Role Of Pregabalin To Decrease Postoperative Pain In Microdiscectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Role Of Pregabalin To Decrease Postoperative Pain In Microdiscectomy: A Randomized Clinical Trial

Conditions
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Pain, Nerve, Prolapsed Intervertebral Disc

Intervention / Treatment
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* Drug: Pregabalin 75mg
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregabalin<br>Participants received Pregabalin 75mg capsule twice daily from preoperative day to 1 week postoperative | Drug: Pregabalin 75mg<br>* 75 mg capsule<br>* Other names: Lyrica (Pregabalin) 75mg;|
| Placebo Comparator: Pregabalin Placebo<br>Participants received Pregabalin placebo capsule matching Pregabalin twice daily from preoperative day to 1 week postoperative | Device: Placebo<br>* 75 mg<br>* Other names: Pregabalin placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from preoperative pain score using a 10 point visual analog scale (VAS pain scale) at 1 week post surgery for PID | 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) | Preoperative and one week postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microdiscectomy, Pregabalin