Postoperative PainMOBILENCT00889148
Morphine COnsumption in Joint Replacement Patients, With and Without GaBapentin Treatment, a RandomIzed ControlLEd Study
A study testing Gabapentin in people with Postoperative Pain and Total Hip Replacement, run by McMaster University at 1 site in Canada.
Trial summary
Total hip 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 in these patients. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Postoperative Pain, Total Hip 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
- 103 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 hip 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 hip arthroplasty
- revision hip arthroplasty
- underlying diseases 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
- participate 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 Primary Hip Arthroplasty
Total hip 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 in these patients. Previous studies have investigated gabapentin in acute postoperative pain and demonstrated reduced postoperative pain, postoperative morphine consumption, morphine related side effects, and postoperative pain scores. To date, this analgesia adjunct has yet to be investigated for total joint arthroplasty patients.
Read the detailed description
The study was submitted to Health Canada and has received the letter of no objection. A randomized, double-blind, placebo-controlled trial will be conducted. The randomization scheme will be prepared and done by the pharmacy department at McMaster University. Ninety patients undergoing primary hip 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 patients will be allocated to a placebo group.
- Conditions
- Postoperative Pain, Total Hip Replacement
- Being tested
- Gabapentin, Placebo
- Keywords
- hip, 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 gabapentin given 2 hrs preoperatively and 200mg three times a day after surgery for 3 days
PlaceboOther
Also called Sugar pill
Half the patients will be randomized to placebo
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Experimental | 600mg of gabapentin will be given orally two hours preoperatively and 200mg for 3 times a day after surgery for three days. Receives: Drug: Gabapentin |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of morphine consumption
Measured: Two years
Secondary outcomes (2)
Side effects
Nausea/Vomiting Sedation Pruritis Visual Disturbance Dizziness/Lightheadness
Measured: Two years
Pain scores
Pain score at rest in PACU, POD1, POD2, POD3 Pain score upon passive movement in PACU, POD1, POD2, POD3 Pain score with weighbearing on POD1, POD2, POD3
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manyat Nantha-Aree, MD, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889148
- Sponsor's protocol ID
- 07-215-THR
- Acronym
- MOBILE
- Status last verified
- Jun 2026
- First submitted
- 27 Apr 2009
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 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 Primary Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT00889148
- Acronym / sponsor ID
- MOBILE / 07-215-THR
- Conditions
- Postoperative Pain, Total Hip Replacement
- Keywords
- hip, arthroplasty, postoperative pain, gabapentin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 28 Apr 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.
Total hip 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 in these patients. Previous studies have investigated gabapentin in acute postoperative pain and demonstrated reduced postoperative pain, postoperative morphine consumption, morphine related side effects, and postoperative pain scores. To date, this analgesia adjunct has yet to be investigated for total joint arthroplasty patients.
Detailed description
The study was submitted to Health Canada and has received the letter of no objection. A randomized, double-blind, placebo-controlled trial will be conducted. The randomization scheme will be prepared and done by the pharmacy department at McMaster University. Ninety patients undergoing primary hip 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 patients will be allocated 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: Gabapentin600mg of gabapentin will be given orally two hours preoperatively and 200mg for 3 times a day after surgery for three days. |
| Placebo | Placebo comparator | Other: Placebo |
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 hip 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 hip arthroplasty
- revision hip arthroplasty
- underlying diseases 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 gabapentin given 2 hrs preoperatively and 200mg three times a day after surgery for 3 days | Drug | Gabapentin |
| PlaceboAlso: Sugar pillHalf the patients will be randomized to placebo | Other | Placebo |
Primary outcome
Amount of morphine consumption
Time frame: Two years
2 secondary outcomes
Side effects
Time frame: Two years
Pain scores
Time frame: Two 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 8 Jun 2026.
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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 Postoperative Pain and Total Hip 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 8 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: Two years). 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 8 Jun 2026.