Role Of Pregabalin To Decrease Postoperative Pain In Microdiscectomy

Pain, Nerve Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04653792
• Other study ID #: preg2020micro
• Status: Completed
• Phase: Phase 4
• Start date: June 4, 2018
• Est. completion date: April 17, 2020

Study information

• Verified date: December 2020
• Source: Ziauddin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: April 17, 2020
• Est. primary completion date: April 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Pain, Nerve
• Pain, Postoperative
• Prolapsed Intervertebral Disc

Intervention

Drug:
• Pregabalin 75mg
75 mg capsule

Device:
• Placebo
75 mg

Locations

Country	Name	City	State
Pakistan	Dr. Ziauddin University Hospital Clifton Campus	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Ziauddin University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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