Role Of Pregabalin To Decrease Postoperative Pain In Microdiscectomy

December 3, 2020 updated by: Shahzaib Riaz Baloch, Ziauddin University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75600
        • Dr. Ziauddin University Hospital Clifton Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pregabalin
Participants received Pregabalin 75mg capsule twice daily from preoperative day to 1 week postoperative
Drug: Pregabalin 75mg
75 mg capsule
Other Names:
  • Lyrica (Pregabalin) 75mg
Placebo Comparator: Pregabalin Placebo
Participants received Pregabalin placebo capsule matching Pregabalin twice daily from preoperative day to 1 week postoperative
Device: Placebo
75 mg
Other Names:
  • Pregabalin placebo

What is the study measuring?

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
Time Frame: 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)
Preoperative and one week postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ziauddin University

Investigators

  • Principal Investigator: Shahzaib Riaz, Ziauddin University Hospital Karachi
  • Study Director: Sohail Rafi, FCPS, Ziauddin University Hospital Karachi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2018

Primary Completion (Actual)

April 17, 2020

Study Completion (Actual)

April 17, 2020

Study Registration Dates

First Submitted

November 27, 2020

First Submitted That Met QC Criteria

December 3, 2020

First Posted (Actual)

December 4, 2020

Study Record Updates

Last Update Posted (Actual)

December 4, 2020

Last Update Submitted That Met QC Criteria

December 3, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • preg2020micro

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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