Intervertebral Disc ProlapsePhase 3NCT02120703
Pregabalin Compared to Gabapentin for Pain Control in Lumbar Disc Surgery
A Phase 3 study testing Pregabalin and Gabapentin in people with Intervertebral Disc Prolapse, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Pregabalin is claimed to have superior analgesic effect at lower doses and better pharmacological profile as compared to gabapentin esp. in perioperative pain control after major surgeries like intervertebral disc surgery. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Intervertebral Disc Prolapse
- What is being tested?
- Pregabalin and Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 sitePakistan
- Study dates
- Feb 2011to Oct 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 30-60 years age
- Any gender
- elective micro discectomy for intervertebral disc prolapse
Who cannot join
- micro discectomy at two or more vertebral levels,
- Instrumentation i.e. pedicle screw fixation, hooks etc.,
- history of steroids or alcohol use,
- Multiple co-morbids i.e. renal failure, chronic liver disease,
- use of anticonvulsant drugs,
- Spinal deformity,
- Obesity (BMI >30), 8) inability to understand and respond VAS and
- 9) patients with known allergy to GABA analogues.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gabapentin vs. Pregabalin for Post Operative Pain in Lumbar Microdiscectomy: a Randomized Controlled Trial.
Pregabalin is claimed to have superior analgesic effect at lower doses and better pharmacological profile as compared to gabapentin esp. in perioperative pain control after major surgeries like intervertebral disc surgery.
The investigators found that pregabalin is equivalent to gabapentin for relief of post-operative pain at a lower dose in patients undergoing intervertebral disc surgery.
- Conditions
- Intervertebral Disc Prolapse
- Being tested
- Pregabalin, Gabapentin
- Keywords
- Pregabalin, gabapentin, microdiscectomy, pain
- Medical subject headings
- Intervertebral Disc Displacement, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Pregablin 75 mg per oral two times a day
GabapentinDrug
Gabapentin 200 mg twice daily per oral
| Study group | Role | What they receive |
|---|---|---|
| gabapentin | Active comparator | Not described Receives: Drug: Gabapentin |
| Pregabalin | Active comparator | Not described Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain measurement using Visual Analogue Score at 24 hours and 7th day of surgery
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startFeb 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral Disc ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghulam Murtaza, Aga Khan University
- Investigators
- Mohsin Qadeer, FCPS, Principal investigator, The Aga Khan University Hospital, Karachi, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120703
- Sponsor's protocol ID
- 173-SUR-ERC-10
- Status last verified
- Apr 2014
- First submitted
- 19 Apr 2014
- Last updated
- 23 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gabapentin vs. Pregabalin for Post Operative Pain in Lumbar Microdiscectomy: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02120703
- Acronym / sponsor ID
- 173-SUR-ERC-10
- Conditions
- Intervertebral Disc Prolapse
- Keywords
- Pregabalin, gabapentin, microdiscectomy, pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pregabalin is claimed to have superior analgesic effect at lower doses and better pharmacological profile as compared to gabapentin esp. in perioperative pain control after major surgeries like intervertebral disc surgery.
The investigators found that pregabalin is equivalent to gabapentin for relief of post-operative pain at a lower dose in patients undergoing intervertebral disc surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gabapentin | Active comparator | Drug: Gabapentin |
| Pregabalin | Active comparator | Drug: Pregabalin |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 30-60 years age
- Any gender
- elective micro discectomy for intervertebral disc prolapse
Key exclusion criteria (8 listed)
- micro discectomy at two or more vertebral levels,
- Instrumentation i.e. pedicle screw fixation, hooks etc.,
- history of steroids or alcohol use,
- Multiple co-morbids i.e. renal failure, chronic liver disease,
- use of anticonvulsant drugs,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregabalinPregablin 75 mg per oral two times a day | Drug | Pregabalin |
| GabapentinGabapentin 200 mg twice daily per oral | Drug | gabapentin |
Primary outcome
Pain
Time frame: 7 days
Pain measurement using Visual Analogue Score at 24 hours and 7th day of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohsin Qadeer, FCPS principal investigator
The Aga Khan University Hospital, Karachi, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pregabalin and Gabapentin in people with Intervertebral Disc Prolapse, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2014.