Post Operative PainTKRNCT01307202
Morphine Consumption in Joint Replacement Patients, With or Without Gabapentin Treatment
A study testing Gabapentin in people with Post Operative Pain and Total Knee Replacement, run by McMaster University at 1 site in Canada.
Trial summary
Total knee arthroplasty is amongst the most painful procedures postoperatively, and pain management can be a challenge. Different measures have been introduced to manage severe postoperative pain int hese patients. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Post Operative Pain, Total Knee Replacement
- What is being tested?
- Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2007to Feb 2011
- 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 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participants aged 19-90
- elective single joint, primary total knee arthroplasty
- use of PCA with morphine for postoperative pain control has been discussed and agreed upon between patient and anesthetist
Who cannot join
- bilateral total knee arthroplasty
- revision knee arthroplasty
- underlying disease of epilepsy, seizure, or chronic pain syndrome
- active gastrointestinal bleeding within the last 6 months
- history of non-steroidal anti-inflammatory drug (NSAID) induced asthma
- known or suspected history of drug or alcohol abuse
Show all 16Show fewer
- participant currently takes gabapentin or pregabalin for any reason
- participant currently takes pain medication that is more potency than codeine or oxycodone (morphine, hydromorphone, meperidine, methadone, fentanyl, including any long acting narcotics)
- known allergy to study medications: gabapentin, morphine, NSAID, acetaminophen
- unable to tolerate morphine
- liver impairments
- kidney impairment or calculated creatinine clearance by Cockcroft-Gault formula is <=60ml/min
- pregnancy or breast-feeding
- participant currently receives associated worker's compensation benefits (WSIB)
- participant unable or unwilling to give written or informed consent
- unable to use PCA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multiple Doses of Gabapentin and Postoperative Morphine Consumption in Total Knee Arthroplasty
Total knee arthroplasty is amongst the most painful procedures postoperatively, and pain management can be a challenge. Different measures have been introduced to manage severe postoperative pain int hese patients. Previous studies have investigated gabapentin in acute postoperative pain and demonstrated reducted pain, postoperative morphine consumption, morphine related side effects, and postoperative pain scores. To date, this analgesia adjunct has yet to be investigated in total joint arthroplasty patients.
Read the detailed description
The study was submitted to Health Canada and received the letter of no objection. A randomized, double-blind, placebo-controlled study. The randomization scheme will be prepared and will be done by the pharmacy department at McMaster University. Ninety patients undergoing primary knee arthroplasty will be recruited from the preoperative clinic. Forty-five patients in each population will be allocated to a gabapentin group and the other forty-five to a placebo group.
- Conditions
- Post Operative Pain, Total Knee Replacement
- Being tested
- Gabapentin, Placebo
- Keywords
- knee, arthroplasty, postoperative pain, 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 Neurontin
600mg of Gabapentin will be given orally preoperatively and 200mg for 3 times a day after surgery for 3 days
PlaceboDrug
Also called Sugar pill
Placebo will match the the gabapentin pill and will be given orally.
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Experimental | Gabapentin 600 mg will be given per oral two hours preoperatively and 200 mg three times daily after surgery (600 mg/day). Receives: Drug: Gabapentin |
| Placebo | Placebo comparator | Placebo will match the the gabapentin pill and will be given orally. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of morphine consumption
Measured: 2 years
Secondary outcomes (1)
Side effects
Nausea/Vomiting Sedation Pruritis Visual Disturbance Dizziness/Lightheadness
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startOct 2007
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Operative 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Responsible party
- Sponsor
- Investigators
- Manyat Nantha-Aree, MD, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307202
- Sponsor's protocol ID
- 07-215-TKR
- Acronym
- TKR
- Status last verified
- Jun 2026
- First submitted
- 28 Feb 2011
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Paul JE, Nantha-Aree M, Buckley N, Shahzad U, Cheng J, Thabane L, Tidy A, DeBeer J, Winemaker M, Wismer D, Punthakee D, Avram V. Randomized controlled trial of gabapentin as an adjunct to perioperative analgesia in total hip arthroplasty patients. Can J Anaesth. 2015 May;62(5):476-84. doi: 10.1007/s12630-014-0310-y. Epub 2015 Mar 14.
PubMed 25772701Paul JE, Nantha-Aree M, Buckley N, Cheng J, Thabane L, Tidy A, DeBeer J, Winemaker M, Wismer D, Punthakee D, Avram V. Gabapentin does not improve multimodal analgesia outcomes for total knee arthroplasty: a randomized controlled trial. Can J Anaesth. 2013 May;60(5):423-31. doi: 10.1007/s12630-013-9902-1. Epub 2013 Mar 12.
PubMed 23479393
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Doses of Gabapentin and Postoperative Morphine Consumption in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01307202
- Acronym / sponsor ID
- TKR / 07-215-TKR
- Conditions
- Post Operative Pain, Total Knee Replacement
- Keywords
- knee, arthroplasty, postoperative pain, gabapentin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Study start
- Oct 2007 (actual)
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 2 Mar 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.
Total knee arthroplasty is amongst the most painful procedures postoperatively, and pain management can be a challenge. Different measures have been introduced to manage severe postoperative pain int hese patients. Previous studies have investigated gabapentin in acute postoperative pain and demonstrated reducted pain, postoperative morphine consumption, morphine related side effects, and postoperative pain scores. To date, this analgesia adjunct has yet to be investigated in total joint arthroplasty patients.
Detailed description
The study was submitted to Health Canada and received the letter of no objection. A randomized, double-blind, placebo-controlled study. The randomization scheme will be prepared and will be done by the pharmacy department at McMaster University. Ninety patients undergoing primary knee arthroplasty will be recruited from the preoperative clinic. Forty-five patients in each population will be allocated to a gabapentin group and the other forty-five to a placebo group.
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: GabapentinGabapentin 600 mg will be given per oral two hours preoperatively and 200 mg three times daily after surgery (600 mg/day). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will match the the gabapentin pill and will be given orally. |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- participants aged 19-90
- elective single joint, primary total knee arthroplasty
- use of PCA with morphine for postoperative pain control has been discussed and agreed upon between patient and anesthetist
Key exclusion criteria (16 listed)
- bilateral total knee arthroplasty
- revision knee arthroplasty
- underlying disease of epilepsy, seizure, or chronic pain syndrome
- active gastrointestinal bleeding within the last 6 months
- history of non-steroidal anti-inflammatory drug (NSAID) induced asthma
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: Neurontin600mg of Gabapentin will be given orally preoperatively and 200mg for 3 times a day after surgery for 3 days | Drug | Gabapentin |
| PlaceboAlso: Sugar pillPlacebo will match the the gabapentin pill and will be given orally. | Drug | Placebo |
Primary outcome
Amount of morphine consumption
Time frame: 2 years
1 secondary outcome
Side effects
Time frame: 2 years
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 10 Jun 2026.
- Derived from this study: PubMed 25772701Paul JE, Nantha-Aree M, Buckley N, Shahzad U, Cheng J, Thabane L, Tidy A, DeBeer J, Winemaker M, Wismer D, Punthakee D, Avram V. Randomized controlled trial of gabapentin as an adjunct to perioperative analgesia in total hip arthroplasty patients. Can J Anaesth. 2015 May;62(5):476-84. doi: 10.1007/s12630-014-0310-y. Epub 2015 Mar 14.
- Derived from this study: PubMed 23479393Paul JE, Nantha-Aree M, Buckley N, Cheng J, Thabane L, Tidy A, DeBeer J, Winemaker M, Wismer D, Punthakee D, Avram V. Gabapentin does not improve multimodal analgesia outcomes for total knee arthroplasty: a randomized controlled trial. Can J Anaesth. 2013 May;60(5):423-31. doi: 10.1007/s12630-013-9902-1. Epub 2013 Mar 12.
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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.
Manyat Nantha-Aree, MD principal investigator
Hamilton Health Sciences Corporation
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 Post Operative Pain and Total Knee Replacement, run by McMaster University at 1 site in Canada.
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 16 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 10 Jun 2026. 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 Canada. 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.
What does the primary outcome measure?
Amount of morphine consumption (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01307202, which also lists 2 linked publications.
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 10 Jun 2026.