Effect of Combined Use of Naloxone and Tramacet on Postop Analgesia in Elderly Patients Having Joint Replacement Surgery
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Lawson Health Research Institute.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Lawson Health Research Institute
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00679614
First received: May 15, 2008
Last updated: September 2, 2009
Last verified: September 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hip Arthroplasty Knee Arthroplasty Spinal Anesthesia |
Drug: tramacet, naloxone Drug: tramacet Drug: Acetaminophen |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Lawson Health Research Institute:
Primary Outcome Measures:
- Morphine use / day [ Time Frame: per day ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 51 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | November 2009 |
| Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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.
|
Drug: tramacet, naloxone
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.
Other Name: tramadol/acetaminophen
|
|
Active Comparator: 2
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.
|
Drug: tramacet
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.
Other Name: tramadol/acetaminophen
|
|
Active Comparator: 3
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.
|
Drug: Acetaminophen
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.
Other Name: Tylenol
|
Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00679614
Contacts
| Contact: Ngozi Imasogie, MBBS, FRCA | 519-646-6000 ext 64219 | Ngozi.Imasogie@sjhc.london.on.ca |
Locations
| Canada, Ontario | |
| St Joseph's Health Care | Recruiting |
| London, Ontario, Canada, N6A 4V2 | |
| Contact: Ngozi Imasogie, MBBS, FRCA UK 519-646-6000 ext 64219 Ngozi.Imasogie@sjhc.london.on.ca | |
| Principal Investigator: Ngozi Imasogie, MBBS, FRCA UK | |
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
| Principal Investigator: | Ngozi Imasogie, MBBS, FRCA UK | Lawson Health Research Institute |
More Information
No publications provided
| Responsible Party: | Ngozi Imasogie, Assistant Professor, St Joseph's Health Care |
| ClinicalTrials.gov Identifier: | NCT00679614 History of Changes |
| Other Study ID Numbers: | R-07-427, 13659 |
| Study First Received: | May 15, 2008 |
| Last Updated: | September 2, 2009 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Lawson Health Research Institute:
|
Tramacet naloxone morphine |
analgesia elderly elderly patients |
Additional relevant MeSH terms:
|
Acetaminophen Morphine Tramadol Naloxone Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Analgesics, Opioid Central Nervous System Depressants Narcotics Narcotic Antagonists |
ClinicalTrials.gov processed this record on May 16, 2013