Role Of Pregabalin To Decrease Postoperative Pain In Microdiscectomy

Ziauddin University

Status and phase: Completed; Phase 4

Conditions: Prolapsed Intervertebral Disc; Pain, Nerve

Treatments: Drug: Pregabalin 75mg; Device: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04653792

preg2020micro

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups, including a placebo group

Pregabalin

Experimental group

Description:

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

Treatment:

Drug: Pregabalin 75mg

Pregabalin Placebo

Placebo Comparator group

Description:

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

Treatment:

Device: Placebo