Tourniquet-induced PainEarly Phase 1NCT01441531
Efficacy of Gabapentin in Prevention of Tourniquet Pain and Hypertension
A Early Phase 1 study testing gabapentin 600 mg po in people with Tourniquet-induced Pain and Tourniquet-induced Hypertension, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The purpose of the study is to find out if taking a dose of gabapentin 600 mg by mouth (po) before surgery will help prevent the development of tourniquet pain and hypertension while the tourniquet is inflated during orif of tibia fracture. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Tourniquet-induced Pain, Tourniquet-induced Hypertension
- What is being tested?
- gabapentin 600 mg po
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jun 2014
- Phase
- Early Phase 1
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient ages 18-64
- ASA physical status 1-3
- Schedule for orif tibia fracture with use of pneumatic tourniquet
Who cannot join
- Allergy to study medications
- polytrauma
- lower extremity crush injury
- chronic opioid use
- sickle cell disease or trait
- peripheral vascular disease
Show all 11Show fewer
- poorly controlled hypertension
- history of DVT/PE
- morbid obesity (BMI > 35)
- patient or surgeon refusal
- patient inability to properly describe postoperative pain to investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Gabapentin in Prevention of Tourniquet Pain and Hypertension During Orif of Tibia Fracture Under General Anesthesia
The purpose of the study is to find out if taking a dose of gabapentin 600 mg by mouth (po) before surgery will help prevent the development of tourniquet pain and hypertension while the tourniquet is inflated during orif of tibia fracture.
- Being tested
- gabapentin 600 mg po, Placebo pill given one hour before surgery
- Keywords
- narcotic use, Other Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gabapentin 600 mg poDrug
Given one hour before surgery
Placebo pill given one hour before surgeryDrug
Placebo pill given
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Experimental | Gabapentin 600 mg po given 1 hour before surgery Receives: Drug: gabapentin 600 mg po |
| Placebo sugar pill | Placebo comparator | Not described Receives: Drug: Placebo pill given one hour before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of tourniquet-induced hypertension
Primary outcome is incidence of tourniquet-induced hypertension, which is defined as an increase of systolic or diastolic blood pressure > 30% from baseline. This will be looked at during the time of tourniquet inflation (from inflation to deflation) during the actual surgical procedure. Usual maximum inflation time is 120 minutes.
Measured: During the tourniquet inflation time period
Secondary outcomes (2)
Postoperative pain
Postoperative pain scores for 24 hours after surgery
Measured: 24 hours
Narcotic use
Total use of morphine, vicodin during 24 hours after surgery
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2011 (estimated)
- Study startJan 2012
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: Unable to recruit patient due to surgical case type. Not worth continuing study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourniquet-induced PainStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Ortiz, Baylor College of Medicine
- Investigators
- Jaime Ortiz, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01441531
- Sponsor's protocol ID
- H-28860
- Status last verified
- Mar 2015
- First submitted
- 21 Sep 2011
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Gabapentin in Prevention of Tourniquet Pain and Hypertension During Orif of Tibia Fracture Under General Anesthesia
- ClinicalTrials.gov ID
- NCT01441531
- Acronym / sponsor ID
- H-28860
- Keywords
- narcotic use, Other Acute Pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit patient due to surgical case type. Not worth continuing study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 27 Sep 2011 (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 purpose of the study is to find out if taking a dose of gabapentin 600 mg by mouth (po) before surgery will help prevent the development of tourniquet pain and hypertension while the tourniquet is inflated during orif of tibia fracture.
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 600 mg poGabapentin 600 mg po given 1 hour before surgery |
| Placebo sugar pill | Placebo comparator | Drug: Placebo pill given one hour before surgery |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient ages 18-64
- ASA physical status 1-3
- Schedule for orif tibia fracture with use of pneumatic tourniquet
Key exclusion criteria (11 listed)
- Allergy to study medications
- polytrauma
- lower extremity crush injury
- chronic opioid use
- sickle cell disease or trait
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 600 mg poGiven one hour before surgery | Drug | Gabapentin |
| Placebo pill given one hour before surgeryPlacebo pill given | Drug | Placebo sugar pill |
Primary outcome
Incidence of tourniquet-induced hypertension
Time frame: During the tourniquet inflation time period
Primary outcome is incidence of tourniquet-induced hypertension, which is defined as an increase of systolic or diastolic blood pressure > 30% from baseline. This will be looked at during the time of tourniquet inflation (from inflation to deflation) during the actual surgical procedure. Usual maximum inflation time is 120 minutes.
2 secondary outcomes
Postoperative pain
Time frame: 24 hours
Narcotic use
Time frame: 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
Related trials for Tourniquet-induced Pain
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.
Jaime Ortiz, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing gabapentin 600 mg po in people with Tourniquet-induced Pain and Tourniquet-induced Hypertension, run by Baylor College of Medicine at 1 site in United States.
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 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: withdrawn, as of the sponsor's last update on 17 Mar 2015. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of tourniquet-induced hypertension (time frame: During the tourniquet inflation time period). 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 Mar 2015.