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NCT Number: NCT04653792

Role Of Pregabalin To Decrease Postoperative Pain In Microdiscectomy

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.

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Key information

Conditions

Pain, Nerve Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Prolapsed Intervertebral Disc Signs and Symptoms Spinal Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dr. Ziauddin University Hospital Clifton Campus

Karachi, Sindh, 75600, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pregabalin 75mg

Drug

75 mg capsule

Other names: Lyrica (Pregabalin) 75mg

PLACEBO

Device

75 mg

Other names: Pregabalin placebo

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Ziauddin University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 4, 2020
Registry last updated
Dec 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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