Role Of Pregabalin To Decrease Postoperative Pain In Microdiscectomy

NCT04653792 | Completed Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: preg2020micro
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Nerve; Prolapsed Intervertebral Disc

Keywords

Microdiscectomy; Pregabalin

Outcome Measures

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

  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

Study Arms (2)

Pregabalin

EXPERIMENTAL

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

Drug: Pregabalin 75mg

Pregabalin Placebo

PLACEBO COMPARATOR

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

Device: Placebo

Interventions

Pregabalin 75mg DRUG

75 mg capsule

Also known as: Lyrica (Pregabalin) 75mg

Pregabalin

Placebo DEVICE

75 mg

Also known as: Pregabalin placebo

Pregabalin Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ziauddin University: lead

Study Sites (1)

Dr. Ziauddin University Hospital Clifton Campus

Karachi, Sindh, 75600, Pakistan

Location

MeSH Terms

Conditions

Neuralgia; Intervertebral Disc Displacement

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Shahzaib Riaz

  Ziauddin University hospital Karachi

  PRINCIPAL INVESTIGATOR

• Sohail Rafi, FCPS

  Ziauddin University Hospital Karachi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident, Orthopedics Department

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: December 4, 2020
• Study Start: June 4, 2018
• Primary Completion: April 17, 2020
• Study Completion: April 17, 2020
• Last Updated: December 4, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)