PainNCT00279487
Preanalgesic Effect of Gabapentin in Total Knee Repair
A study testing Gabapentin in people with Pain, run by Texas Health Resources at 1 site in United States.
Trial summary
The purpose of this study is to determine whether gabapentin, as a one time administration prior to a total knee replacement procedure, has opioid sparing effects and a reduction in pain scores. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Gabapentin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Aug 2007
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing total knee replacement who received pain management by the following modality:
- Intravenous patient-controlled analgesia (IV-PCA) opioid
- Local femoral nerve block with 1.5% mepivacaine 20 ml and 0.5% ropivacaine 20 ml
Who cannot join
- Age < 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Presbyterian Hospital of Dallas
Dallas, Texas, 75231
About this study
The purpose of this study is to determine whether gabapentin, as a one time administration prior to a total knee replacement procedure, has opioid sparing effects and a reduction in pain scores.
- Conditions
- Pain
- Being tested
- Gabapentin, Placebos
- Keywords
- Patients undergoing total knee replacement who received pain management by the following modality:, IV PCA opioid, Local femoral nerve block with 1.5% Mepivacaine & 0.5% Ropivacaine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
PlacebosDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Patients will receive 1200mg gabapentin 1-2 hours prior to surgery. Receives: Drug: Gabapentin |
| Arm 2 | Placebo comparator | Patients will receive placebo 1-2 hours prior to surgery. Receives: Drug: Placebos |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2006 (estimated)
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Health Resources
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rob Hutchison, Principal investigator, Texas Health Resources
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279487
- Sponsor's protocol ID
- P768
- Status last verified
- Oct 2016
- First submitted
- 16 Jan 2006
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preanalgesic Effect of Gabapentin in Total Knee Repair
- ClinicalTrials.gov ID
- NCT00279487
- Acronym / sponsor ID
- P768
- Conditions
- Pain
- Keywords
- Patients undergoing total knee replacement who received pain management by the following modality:, IV PCA opioid, Local femoral nerve block with 1.5% Mepivacaine & 0.5% Ropivacaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Texas Health ResourcesUniversity, hospital or other
- Study completion
- Aug 2007 (actual)
- First posted
- 19 Jan 2006 (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 this study is to determine whether gabapentin, as a one time administration prior to a total knee replacement procedure, has opioid sparing effects and a reduction in pain scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: GabapentinPatients will receive 1200mg gabapentin 1-2 hours prior to surgery. |
| Arm 2 | Placebo comparator | Drug: PlacebosPatients will receive placebo 1-2 hours prior to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing total knee replacement who received pain management by the following modality:
Key exclusion criteria (1 listed)
- Age < 18 years old
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 | Drug | Arm 1 |
| Placebos | Drug | Arm 2 |
Primary outcome
Not reported in the source record.
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 26 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Rob Hutchison principal investigator
Texas Health Resources
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gabapentin in people with Pain, run by Texas Health Resources 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 1 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 26 Oct 2016. 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.
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.
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 26 Oct 2016.