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Role Of Pregabalin To Decrease Postoperative Pain In Microdiscectomy

NCT ID: NCT04653792

Last Updated: 2020-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-04

Study Completion Date

2020-04-17

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.

Conditions

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Pain, Nerve Prolapsed Intervertebral Disc

Keywords

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Microdiscectomy Pregabalin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Pregabalin

Participants received Pregabalin 75mg capsule twice daily from preoperative day to 1 week postoperative

Group Type EXPERIMENTAL

Pregabalin 75mg

Intervention Type DRUG

75 mg capsule

Pregabalin Placebo

Participants received Pregabalin placebo capsule matching Pregabalin twice daily from preoperative day to 1 week postoperative

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

75 mg

Interventions

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Pregabalin 75mg

75 mg capsule

Intervention Type DRUG

Placebo

75 mg

Intervention Type DEVICE

Other Intervention Names

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Lyrica (Pregabalin) 75mg Pregabalin placebo

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ziauddin University

OTHER

Sponsor Role lead

Responsible Party

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Shahzaib Riaz Baloch

Senior Resident, Orthopedics Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shahzaib Riaz

Role: PRINCIPAL_INVESTIGATOR

Ziauddin University hospital Karachi

Sohail Rafi, FCPS

Role: STUDY_DIRECTOR

Ziauddin University Hospital Karachi

Locations

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Dr. Ziauddin University Hospital Clifton Campus

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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preg2020micro

Identifier Type: -

Identifier Source: org_study_id