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| Sponsored by: |
Lawson Health Research Institute |
|---|---|
| Information provided by: | Lawson Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT00679614 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment |
| 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. |
| Estimated Enrollment: | 51 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | November 2008 |
| Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
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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.
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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.
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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.
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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.
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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.
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Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ngozi Imasogie, MBBS, FRCA | 519-646-6000 ext 64219 | Ngozi.Imasogie@sjhc.london.on.ca |
| Canada, Ontario | |
| St Joseph's Health Care | |
| London, Ontario, Canada, N6A 4V2 | |
More Information
| Responsible Party: | St Joseph's Health Care ( Ngozi Imasogie, Assistant Professor ) |
| Study ID Numbers: | R-07-427 |
| Study First Received: | May 15, 2008 |
| Last Updated: | May 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00679614 |
| Health Authority: | Canada: Health Canada |
|
Tramacet naloxone morphine |
analgesia elderly elderly patients |
|
Morphine Celecoxib Tramadol |
Oxycodone Acetaminophen Naloxone |
|
Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Narcotic Antagonists Physiological Effects of Drugs |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions |
