Pain, Nerve, Prolapsed Intervertebral Disc
Conditions
Keywords
Microdiscectomy, Pregabalin
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.
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.
Interventions
DRUGPregabalin 75mg
75 mg capsule
DEVICEPlacebo
75 mg
Sponsors
Ziauddin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Pakistan
Outcome results
None listed