Hip ArthroplastyPhase 3NCT00679614
Effect of Combined Use of Naloxone and Tramacet on Postop Analgesia in Elderly Patients Having Joint Replacement Surgery
A Phase 3 study testing tramacet, naloxone, tramacet and Acetaminophen in people with Hip Arthroplasty and Knee Arthroplasty, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Patients over 70 years of age, scheduled for joint replacement surgery will be randomized to tramacet/ naloxone plus morphine PCA or to morphine PCA to assess quality of analgesia in the postoperative period. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Hip Arthroplasty, Knee Arthroplasty, Spinal Anesthesia
- What is being tested?
- tramacet, naloxone, tramacet and Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 17 Dec 2007to 31 May 2011
- Phase
- Phase 3
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 70 years and older*
- Able to give informed consent
- Able to communicate in English
- Having elective hip/knee arthroplasty
- ASA physical status 1-3.
Who cannot join
- Allergies to any of the following: naloxone, tramacet, NSAIDs, or local anesthetic
- Contraindication to spinal anesthesia
- Contraindication to use of tramacet or celebrex
- ASA physical status 4
- Chronic opioid use
- Chronic pain syndrome All the above will be included in the letter of information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Combined Use of Naloxone and Tramacet on Postoperative Analgesia in Elderly Patients Having Joint Replacement Surgery: a Randomized Controlled Study.
Patients over 70 years of age, scheduled for joint replacement surgery will be randomized to tramacet/ naloxone plus morphine PCA or to morphine PCA to assess quality of analgesia in the postoperative period.
The primary objective is to determine opioid use during combined use of oral tramacet and naloxone infusion perioperatively in elderly patients (70 yrs and older) having elective knee/ hip arthroplasty under spinal anesthesia.
Read more
Secondary objectives are to determine the incidence VAS scores ≥4 and adverse effects such as nausea, vomiting, sedation, respiratory depression, pruritus, confusion, and time of independent mobilization.
Hypothesis: Perioperative naloxone infusion and tramacet provides adequate analgesia in elderly patients undergoing total knee/hip arthroplasty and is associated with 80% reduction in opioid use and reduced opioid-induced side effects.
- Conditions
- Hip Arthroplasty, Knee Arthroplasty, Spinal Anesthesia
- Being tested
- tramacet, naloxone, tramacet, Acetaminophen
- Keywords
- Tramacet, naloxone, morphine, analgesia, elderly, elderly patients
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tramacet, naloxoneDrug
Also called tramadol/acetaminophen
Group A: oral tramacet 2 tablets preoperatively, then 2 tablets every 6 hours for 5 days then 1-2 tablets of tramacet prn to a maximum of 8 tablets per day. A naloxone infusion will started preop at 0.25ug/kg/hr and will continue during patient's stay in hospital (an equivalent of 400ug over 24 hours in a 70 kg man). Infusion discontinued 1 hour before patient discharge. All the patients in groups A and B will be provided Morphine PCA for the duration of their hospital stay. Use of morphine PCA will be noted.Oral celebrex 200mg will be given to all the patient twice a day for five days as per our standard practice. All patients will receive peri-articular infiltration with local anesthetic solution intraoperatively by the surgeon as per our standard practice.
tramacetDrug
Also called tramadol/acetaminophen
Group B: oral tramacet 2 tablets preop,then 2 tablets every 6 hours for five days(or until discharge. Patient VAS after discontinuation of morphine PCA may dictate addition of oral narcotic oxycodone after discharge). Group also receives saline infusion at 4-6mls/hour during hospital stay.All patients in groups A and B will have Morphine PCA during hospital stay. Use of morphine PCA will be noted. Oral celebrex 200mg will be given to all the patient twice a day for five days as per our standard practice. All patients will receive peri-articular infiltration with local anesthetic solution intraopby the surgeon as per our standard practice.
AcetaminophenDrug
Also called Tylenol
Group C will receive oral Acetaminophen tablets 1 gm preoperatively and subsequently 6 hourly plus an infusion of saline (placebo) at a rate of 4-6mls / hour for the duration of their stay. Oral celebrex 200mg will be given to all the patient twice a day for five days as per our standard practice. All patients will receive peri-articular infiltration with local anesthetic solution intraoperatively by the surgeon as per our standard practice. The Visual Analogue Scale, the Ramsay Sedation Score and the Mini Mental State Exam will be used to assess the patients for pain, sedation and confusion every 6 hours while in hospital.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Group A oral tramacet 2 tablets preoperatively, 2 tablets every 6 hours for 5 days then 1-2 tablets of tramacet prn to a maximum of 8 tablets per day. Naloxone infusion starting preop at 0.25ug/kg/hr and continuing during hospital stay (an equivalent of 400ug over 24 hours in a 70 kg man). The infusion will be discontinued 1 hour before patient discharge. Receives: Drug: tramacet, naloxone |
| 2 | Active comparator | Group B will receive oral tramacet 2 tablets preoperatively and then 2 tablets every 6 hours for five days. ( or until discharge. Patient VAS after discontinuation of morphine PCA may dictate addition of oral narcotic oxycodone after discharge). This group will also receive saline infusion at 4-6mls / hour for the duration of the hospital stay. Receives: Drug: tramacet |
| 3 | Active comparator | Group C will receive oral Acetaminophen tablets 1 gm preoperatively and subsequently 6 hourly plus an infusion of saline (placebo) at a rate of 4-6mls / hour for the duration of their stay. Receives: Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine use / day
Measured: per day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2008 (estimated)
- Study start17 Dec 2007
- Primary completion31 May 2011
- Study completion31 May 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ngozi Imasogie, MBBS, FRCA UK, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679614
- Sponsor's protocol ID
- R-07-427
- Other IDs
- 13659
- Status last verified
- Aug 2017
- First submitted
- 15 May 2008
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Combined Use of Naloxone and Tramacet on Postoperative Analgesia in Elderly Patients Having Joint Replacement Surgery: a Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT00679614
- Acronym / sponsor ID
- R-07-427
- Conditions
- Hip Arthroplasty, Knee Arthroplasty, Spinal Anesthesia
- Keywords
- Tramacet, naloxone, morphine, analgesia, elderly, elderly patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 17 Dec 2007 (actual)
- Primary completion
- 31 May 2011 (actual)
- Study completion
- 31 May 2011 (actual)
- First posted
- 19 May 2008 (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.
Patients over 70 years of age, scheduled for joint replacement surgery will be randomized to tramacet/ naloxone plus morphine PCA or to morphine PCA to assess quality of analgesia in the postoperative period.
The primary objective is to determine opioid use during combined use of oral tramacet and naloxone infusion perioperatively in elderly patients (70 yrs and older) having elective knee/ hip arthroplasty under spinal anesthesia.
Secondary objectives are to determine the incidence VAS scores ≥4 and adverse effects such as nausea, vomiting, sedation, respiratory depression, pruritus, confusion, and time of independent mobilization.
Hypothesis: Perioperative naloxone infusion and tramacet provides adequate analgesia in elderly patients undergoing total knee/hip arthroplasty and is associated with 80% reduction in opioid use and reduced opioid-induced side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: tramacet, naloxoneGroup A oral tramacet 2 tablets preoperatively, 2 tablets every 6 hours for 5 days then 1-2 tablets of tramacet prn to a maximum of 8 tablets per day. Naloxone infusion starting preop at 0.25ug/kg/hr and continuing during hospital stay (an equivalent of 400ug over 24 hours in a 70 kg man). The infusion will be discontinued 1 hour before patient discharge. |
| 2 | Active comparator | Drug: tramacetGroup B will receive oral tramacet 2 tablets preoperatively and then 2 tablets every 6 hours for five days. ( or until discharge. Patient VAS after discontinuation of morphine PCA may dictate addition of oral narcotic oxycodone after discharge). This group will also receive saline infusion at 4-6mls / hour for the duration of the hospital stay. |
| 3 | Active comparator | Drug: AcetaminophenGroup C will receive oral Acetaminophen tablets 1 gm preoperatively and subsequently 6 hourly plus an infusion of saline (placebo) at a rate of 4-6mls / hour for the duration of their stay. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Aged 70 years and older*
- Able to give informed consent
- Able to communicate in English
- Having elective hip/knee arthroplasty
- ASA physical status 1-3.
Key exclusion criteria (6 listed)
- Allergies to any of the following: naloxone, tramacet, NSAIDs, or local anesthetic
- Contraindication to spinal anesthesia
- Contraindication to use of tramacet or celebrex
- ASA physical status 4
- Chronic opioid use
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 |
|---|---|---|
| tramacet, naloxoneAlso: tramadol/acetaminophenGroup A: oral tramacet 2 tablets preoperatively, then 2 tablets every 6 hours for 5 days then 1-2 tablets of tramacet prn to a maximum of 8 tablets per day. A naloxone infusion will started preop at 0.25ug/kg/hr and will continue during patient's stay in hospital (an equivalent of 400ug over 24 hours in a 70 kg man). Infusion discontinued 1 hour before patient discharge. All the patients in groups A and B will be provided Morphine PCA for the duration of their hospital stay. Use of morphine PCA will be noted.Oral celebrex 200mg will be given to all the patient twice a day for five days as per our standard practice. All patients will receive peri-articular infiltration with local anesthetic solution intraoperatively by the surgeon as per our standard practice. | Drug | 1 |
| tramacetAlso: tramadol/acetaminophenGroup B: oral tramacet 2 tablets preop,then 2 tablets every 6 hours for five days(or until discharge. Patient VAS after discontinuation of morphine PCA may dictate addition of oral narcotic oxycodone after discharge). Group also receives saline infusion at 4-6mls/hour during hospital stay.All patients in groups A and B will have Morphine PCA during hospital stay. Use of morphine PCA will be noted. Oral celebrex 200mg will be given to all the patient twice a day for five days as per our standard practice. All patients will receive peri-articular infiltration with local anesthetic solution intraopby the surgeon as per our standard practice. | Drug | 2 |
| AcetaminophenAlso: TylenolGroup C will receive oral Acetaminophen tablets 1 gm preoperatively and subsequently 6 hourly plus an infusion of saline (placebo) at a rate of 4-6mls / hour for the duration of their stay. Oral celebrex 200mg will be given to all the patient twice a day for five days as per our standard practice. All patients will receive peri-articular infiltration with local anesthetic solution intraoperatively by the surgeon as per our standard practice. The Visual Analogue Scale, the Ramsay Sedation Score and the Mini Mental State Exam will be used to assess the patients for pain, sedation and confusion every 6 hours while in hospital. | Drug | 3 |
Primary outcome
Morphine use / day
Time frame: per day
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 28 Aug 2017.
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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.
Ngozi Imasogie, MBBS, FRCA UK principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tramacet, naloxone, tramacet and Acetaminophen in people with Hip Arthroplasty and Knee Arthroplasty, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 5 inclusion and 6 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 28 Aug 2017. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
Morphine use / day (time frame: per day). 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 28 Aug 2017.