Herniated DiscPhase 2NCT01014520
Efficacy of Gabapentin or Amitriptyline to Reduce Postoperative Pain After Lumbar Laminectomy and Diskectomy
A Phase 2 study testing Gabapentin , Amitriptyline in people with Herniated Disc and Intervertebral Disc Displacement, run by Tabriz University at 1 site in Iran.
Trial summary
The hypothesis of this study is that Gabapentin or Amitriptyline has no role in preemptive analgesia to reduce postoperative pain after lumbar diskectomies. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Herniated Disc, Intervertebral Disc Displacement
- What is being tested?
- Gabapentin , Amitriptyline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIran
- Study dates
- May 2009to Mar 2010
- Phase
- Phase 2
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed Informed Consent
- Age:18 to 60
- Weight: 60 to 80 Kg
- ASA Class: I,II
- Concordant physical and imaging findings in favor of symptomatic lumbar disk herniation
- Single level lumbar disk herniation unresponsive to medical treatment
Who cannot join
- Previous consumption of Gabapentin or Amitriptyline
- Known allergy to investigated drugs
- Reluctant to sign informed consent
- Previous history of intolerance to narcotics
- Simultaneous lumbar diskectomy and a fusion technique
- Known renal failure
Show all 11Show fewer
- Pregnancy
- Contraindications to Amitriptyline or Gabapentin prescription
- Unable to use PCA
- Habitual use of alcohol or opium
- History of analgesic consumption during the last 24hours
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Tabriz University of Medical Sciences
Tabriz, East Azerbayjan, 5166614756
Dawood Aghamohammadi, MD, +98 411 3347054 ext. 1065, daghamohamadi@yahoo.com
Payman Vahedi, MD, +98 411 3340830, payman.vahedi@gmail.com
About this study
Official title: Comparative Effects of Single Dose Preemptive Gabapentin or Amitriptyline on Postoperative Pain and Opioid Consumption in Single Level Lumbar Laminectomy and Diskectomy: A Double Blind RCT With Placebo Control
The hypothesis of this study is that Gabapentin or Amitriptyline has no role in preemptive analgesia to reduce postoperative pain after lumbar diskectomies.
Read the detailed description
Pain suppression plays a decisive role in patients' satisfaction following lumbar diskectomies, as the psychological component of the pain is a major cause of treatment failure.
Controversy exists whether preemptive prescription of gabapentin, as a known contributor to reduce postoperative pain, has a role in patients undergoing laminectomy for lumbar diskectomy or spinal canal stenosis.The aim of this study is to test the efficacy of amitriptyline and gabapentin in this group of neurosurgical patients.
- Conditions
- Herniated Disc, Intervertebral Disc Displacement
- Being tested
- Gabapentin , Amitriptyline
- Keywords
- Lumbar, Diskectomy, Laminectomy
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gabapentin , AmitriptylineDrug
Also called Neurontin, Elavil
Capsule, 300 mg, oral, single dose 2 hours before surgery
Capsule,300 mg containing 25 mg Amitriptyline, oral, single dose 2 hours before surgery
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Experimental | Neurontin Receives: Drug: Gabapentin , Amitriptyline |
| Amitriptyline | Experimental | Elavil Receives: Drug: Gabapentin , Amitriptyline |
What is being measured
The primary outcome is the main question the study is designed to answer.
30% reduction in opium consumption in either study arms compared to the placebo group
Measured: Within the first 24 hours after surgery
Secondary outcomes (1)
30% reduction in pain according to visual analogue scale in either study arms compared to the placebo group
Measured: Within the first 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study startMay 2009
- Primary completionFeb 2010 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herniated DiscStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tabriz University
- Sponsor type
- University, hospital or other
- Investigators
- Dawood Aghamohammadi, MD, Study chair, Tabriz UniversityPayman Vahedi, MD, Principal investigator, Tabriz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014520
- Sponsor's protocol ID
- 883
- Status last verified
- Nov 2009
- First submitted
- 14 Nov 2009
- Last updated
- 17 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Single Dose Preemptive Gabapentin or Amitriptyline on Postoperative Pain and Opioid Consumption in Single Level Lumbar Laminectomy and Diskectomy: A Double Blind RCT With Placebo Control
- ClinicalTrials.gov ID
- NCT01014520
- Acronym / sponsor ID
- 883
- Conditions
- Herniated Disc, Intervertebral Disc Displacement
- Keywords
- Lumbar, Diskectomy, Laminectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tabriz UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Feb 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 17 Nov 2009 (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.
The hypothesis of this study is that Gabapentin or Amitriptyline has no role in preemptive analgesia to reduce postoperative pain after lumbar diskectomies.
Detailed description
Pain suppression plays a decisive role in patients' satisfaction following lumbar diskectomies, as the psychological component of the pain is a major cause of treatment failure.
Controversy exists whether preemptive prescription of gabapentin, as a known contributor to reduce postoperative pain, has a role in patients undergoing laminectomy for lumbar diskectomy or spinal canal stenosis.The aim of this study is to test the efficacy of amitriptyline and gabapentin in this group of neurosurgical patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Experimental | Drug: Gabapentin , AmitriptylineNeurontin |
| Amitriptyline | Experimental | Drug: Gabapentin , AmitriptylineElavil |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Signed Informed Consent
- Age:18 to 60
- Weight: 60 to 80 Kg
- ASA Class: I,II
- Concordant physical and imaging findings in favor of symptomatic lumbar disk herniation
Key exclusion criteria (11 listed)
- Previous consumption of Gabapentin or Amitriptyline
- Known allergy to investigated drugs
- Reluctant to sign informed consent
- Previous history of intolerance to narcotics
- Simultaneous lumbar diskectomy and a fusion technique
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 |
|---|---|---|
| Gabapentin , AmitriptylineAlso: Neurontin, ElavilCapsule, 300 mg, oral, single dose 2 hours before surgery Capsule,300 mg containing 25 mg Amitriptyline, oral, single dose 2 hours before surgery | Drug | Amitriptyline, Gabapentin |
Primary outcome
30% reduction in opium consumption in either study arms compared to the placebo group
Time frame: Within the first 24 hours after surgery
1 secondary outcome
30% reduction in pain according to visual analogue scale in either study arms compared to the placebo group
Time frame: Within the first 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2009.
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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.
Dawood Aghamohammadi, MD study chair
Tabriz University
Payman Vahedi, MD principal investigator
Tabriz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gabapentin , Amitriptyline in people with Herniated Disc and Intervertebral Disc Displacement, run by Tabriz University at 1 site in Iran.
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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 17 Nov 2009. 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 Iran. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dawood Aghamohammadi, MD (+98 411 3340830 ext. 1065, daghamohamadi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30% reduction in opium consumption in either study arms compared to the placebo group (time frame: Within the first 24 hours after surgery). 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 17 Nov 2009.