Postoperative PainPhase 4L12-078NCT01680549
Pain Control With Total Knee Replacement
A Phase 4 study testing Gabapentin in people with Postoperative Pain, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial summary
The purpose of this project is to study the effects of gabapentin on pain control in the perioperative and post-operative period of total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 25 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Gabapentin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Feb 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Age > 25 years old
- Primary osteoarthritis of the knee
- Must be undergoing unilateral total knee arthroplasty
- Anesthesia assesment score I, II, or III
Who cannot join
- Severe joint malalignment (defined as varus/valgus angle > 20 deg)
- Use of gabapentin pre-operatively
- History of chronic pain (currently under treatment)
- History of substance abuse
- Impaired kidney function (defined as creatinine > 1.5)
- Epilepsy (currently on medication for treatment)
Show all 9Show fewer
- Known allergy to Gabapentin
- Known history of depression or suicidal thoughts and behaviors
- Anyone who is not a candidate for general anesthesia or any other portion of the investigator's standard of care.
Trial locations and contacts
1 site in 1 country.
United States1 site
TTUHSC Orthopaedic Surgery MS 9436
Lubbock, Texas, 79430
About this study
Official title: Pain Control With Total Knee Replacement: Does Gabapentin Affect Narcotic Usage and Functional Outcome? A Randomized Controlled Trial.
The purpose of this project is to study the effects of gabapentin on pain control in the perioperative and post-operative period of total knee arthroplasty.
Read the detailed description
Being able to understand and better control pain in patients undergoing total knee arthroplasty will help in many different areas of medicine. Gabapentin is one pain control modality that has been used by many different orthopaedic surgeons with excellent retrospective results. Gabapentin, however, has never been studied, to the investigators knowledge, in a prospective randomized fashion in the United States for total knee arthroplasty. This study will be the first of its kind to truly compare the effects of gabapentin, a drug that has been proven safe in many other areas of medicine, with placebo for total knee arthroplasty by analyzing post-operative narcotic usage, function and sleep quality.
- Conditions
- Postoperative Pain
- Being tested
- Gabapentin
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called Fanatrex, Gabarone, Gralise, Horizant
Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Active comparator | Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days. Receives: Drug: Gabapentin |
| Placebo | Placebo comparator | Placebo 600 mg po preoperatively and continued postoperatively 300 mg po q8hours X 3 days Receives: Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Pain Scores
Patient's pain assessed by the Visual Analog Scale (VAS - Units on a scale) on postoperative days 0, 1 and 2.
Scale range: 0-100 Higher Values = More Pain
Measured: 3 days
Secondary outcomes (3)
Narcotics Consumption
Narcotics consumption was recorded on postoperative days 0, 1, and 2.
Measured: 3 days
Knee Range of Motion
Patient knee range of motion was assessed on postoperative days 0, 1 and 2.
Measured: 3 days
Patient Restfulness
Percentage of self reported patient restfulness was recorded on postoperative days 0, 1 and 2.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George W Brindley, MD, Principal investigator, TTUHSC dept. Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680549
- Sponsor's protocol ID
- L12-078
- Acronym
- L12-078
- Status last verified
- Jan 2024
- First submitted
- 4 Sep 2012
- Last updated
- 31 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Control With Total Knee Replacement: Does Gabapentin Affect Narcotic Usage and Functional Outcome? A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01680549
- Acronym / sponsor ID
- L12-078 / L12-078
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 7 Sep 2012 (estimated)
- Results
- Posted 17 Mar 2017
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 project is to study the effects of gabapentin on pain control in the perioperative and post-operative period of total knee arthroplasty.
Detailed description
Being able to understand and better control pain in patients undergoing total knee arthroplasty will help in many different areas of medicine. Gabapentin is one pain control modality that has been used by many different orthopaedic surgeons with excellent retrospective results. Gabapentin, however, has never been studied, to the investigators knowledge, in a prospective randomized fashion in the United States for total knee arthroplasty. This study will be the first of its kind to truly compare the effects of gabapentin, a drug that has been proven safe in many other areas of medicine, with placebo for total knee arthroplasty by analyzing post-operative narcotic usage, function and sleep quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Active comparator | Drug: GabapentinGabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days. |
| Placebo | Placebo comparator | Drug: GabapentinPlacebo 600 mg po preoperatively and continued postoperatively 300 mg po q8hours X 3 days |
Who may qualify
- Ages
- 25 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Age > 25 years old
Key exclusion criteria (9 listed)
- Severe joint malalignment (defined as varus/valgus angle > 20 deg)
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 |
|---|---|---|
| GabapentinAlso: Fanatrex, Gabarone, Gralise, HorizantGabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days. | Drug | Gabapentin, Placebo |
Primary outcome
Patient Pain Scores
Time frame: 3 days
Patient's pain assessed by the Visual Analog Scale (VAS - Units on a scale) on postoperative days 0, 1 and 2. Scale range: 0-100 Higher Values = More Pain
3 secondary outcomes
Narcotics Consumption
Time frame: 3 days
Knee Range of Motion
Time frame: 3 days
Patient Restfulness
Time frame: 3 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
George W Brindley, MD principal investigator
TTUHSC dept. Orthopaedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gabapentin in people with Postoperative Pain, run by Texas Tech University Health Sciences Center 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 4 inclusion and 9 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 31 Jan 2024. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient Pain Scores (time frame: 3 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 31 Jan 2024.