A Phase 4 interventional study of Pregabalin 75mg and Placebo in Pain, Nerve and Prolapsed Intervertebral Disc, sponsored by Ziauddin University. Completed at 1 site in Pakistan. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-12-04.
Sponsored by Ziauddin University · Phase 4, Interventional, and Treatment
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.
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.
478 studies on the registry are indexed under Intervertebral Disc Displacement; 104 are open to participants now.
This study's enrollment of 84 is above the median of 63 across 344 interventional studies indexed under Intervertebral Disc Displacement.
Browse Intervertebral Disc Displacement studies →Ziauddin University is the lead sponsor of 48 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Participants received Pregabalin 75mg capsule twice daily from preoperative day to 1 week postoperative
Drug: Pregabalin 75mg
Participants received Pregabalin placebo capsule matching Pregabalin twice daily from preoperative day to 1 week postoperative
Device: Placebo
75 mg capsule
Also known as: Lyrica (Pregabalin) 75mg
75 mg
Also known as: Pregabalin placebo
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)
Time frame: Preoperative and one week postoperative
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Displacement→
Ziauddin University