Back to resultsRole Of Pregabalin To Decrease Postoperative Pain In Microdiscectomy
Primary Purpose
Pain, Nerve, Prolapsed Intervertebral Disc
Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Pregabalin 75mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Nerve focused on measuring Microdiscectomy, Pregabalin
Eligibility Criteria
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.
Sites / Locations
- Dr. Ziauddin University Hospital Clifton Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Pregabalin
Pregabalin Placebo
Arm Description
Participants received Pregabalin 75mg capsule twice daily from preoperative day to 1 week postoperative
Participants received Pregabalin placebo capsule matching Pregabalin twice daily from preoperative day to 1 week postoperative
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT04653792
First Posted
November 27, 2020
Last Updated
December 3, 2020
Sponsor
Ziauddin University
1. Study Identification
Unique Protocol Identification Number
NCT04653792
Brief Title
Role Of Pregabalin To Decrease Postoperative Pain In Microdiscectomy
Official Title
Role Of Pregabalin To Decrease Postoperative Pain In Microdiscectomy: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 4, 2018 (Actual)
Primary Completion Date
April 17, 2020 (Actual)
Study Completion Date
April 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziauddin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Nerve, Prolapsed Intervertebral Disc
Keywords
Microdiscectomy, Pregabalin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pregabalin
Arm Type
Experimental
Arm Description
Participants received Pregabalin 75mg capsule twice daily from preoperative day to 1 week postoperative
Arm Title
Pregabalin Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received Pregabalin placebo capsule matching Pregabalin twice daily from preoperative day to 1 week postoperative
Intervention Type
Drug
Intervention Name(s)
Pregabalin 75mg
Other Intervention Name(s)
Lyrica (Pregabalin) 75mg
Intervention Description
75 mg capsule
Intervention Type
Device
Intervention Name(s)
Placebo
Other Intervention Name(s)
Pregabalin placebo
Intervention Description
75 mg
Primary Outcome Measure Information:
Title
change from preoperative pain score using a 10 point visual analog scale (VAS pain scale) at 1 week post surgery for PID
Description
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)
Time Frame
Preoperative and one week postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahzaib Riaz
Organizational Affiliation
Ziauddin University hospital Karachi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sohail Rafi, FCPS
Organizational Affiliation
Ziauddin University Hospital Karachi
Official's Role
Study Director
Facility Information:
Facility Name
Dr. Ziauddin University Hospital Clifton Campus
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75600
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
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Role Of Pregabalin To Decrease Postoperative Pain In Microdiscectomy
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