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Effect of Combined Use of Naloxone and Tramacet on Postop Analgesia in Elderly Patients Having Joint Replacement Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00679614
First Posted: May 19, 2008
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lawson Health Research Institute
  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 (Participant, 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 ]

Enrollment: 45
Actual Study Start Date: December 17, 2007
Study Completion Date: May 31, 2011
Primary Completion Date: May 31, 2011 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 70 years and older*
  2. Able to give informed consent
  3. Able to communicate in English
  4. Having elective hip/knee arthroplasty
  5. ASA physical status 1-3.

Exclusion Criteria:

  1. Allergies to any of the following: naloxone, tramacet, NSAIDs, or local anesthetic
  2. Contraindication to spinal anesthesia
  3. Contraindication to use of tramacet or celebrex
  4. ASA physical status 4
  5. Chronic opioid use
  6. Chronic pain syndrome All the above will be included in the letter of information
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00679614


Locations
Canada, Ontario
St Joseph's Health Care
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Ngozi Imasogie, MBBS, FRCA UK Lawson Health Research Institute
  More Information

Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00679614     History of Changes
Other Study ID Numbers: R-07-427
13659
First Submitted: May 15, 2008
First Posted: May 19, 2008
Last Update Posted: August 28, 2017
Last Verified: August 2017

Keywords provided by Lawson Health Research Institute:
Tramacet
naloxone
morphine
analgesia
elderly
elderly patients

Additional relevant MeSH terms:
Morphine
Tramadol
Acetaminophen
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics
Narcotic Antagonists