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Role Of Pregabalin To Decrease Postoperative Pain In Microdiscectomy

Sponsor
Ziauddin University (Other)
Overall Status
Completed
CT.gov ID
NCT04653792
Collaborator
(none)
84
Enrollment
1
Location
2
Arms
22.4
Actual Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Pregabalin 75mg
  • Device: Placebo
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Role Of Pregabalin To Decrease Postoperative Pain In Microdiscectomy: A Randomized Clinical Trial
Actual Study Start Date :
Jun 4, 2018
Actual Primary Completion Date :
Apr 17, 2020
Actual Study Completion Date :
Apr 17, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dr. Ziauddin University Hospital Clifton Campus Karachi Sindh Pakistan 75600

    Sponsors and Collaborators

    • Ziauddin University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shahzaib Riaz Baloch, Senior Resident, Orthopedics Department, Ziauddin University
    ClinicalTrials.gov Identifier:
    NCT04653792
    Other Study ID Numbers:
    • preg2020micro
    First Posted:
    Dec 4, 2020
    Last Update Posted:
    Dec 4, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Shahzaib Riaz Baloch, Senior Resident, Orthopedics Department, Ziauddin University
    Microdiscectomy
    Pregabalin
    Additional relevant MeSH terms:
    Intervertebral Disc Displacement
    Neuralgia
    Pain, Postoperative
    Pregabalin

    Study Results

    No Results Posted as of Dec 4, 2020