Low Dose Spinal Bupivacaine for Total Knee Replacement and Recovery Room Wait Time

This study has been completed.
Sponsor:
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00537472
First received: September 28, 2007
Last updated: April 16, 2009
Last verified: April 2009
  Purpose

This study plans to investigate whether a reduced dose of bupivacaine (a local anesthetic numbing drug) injected into the spinal space for a total knee replacement will result in a shorter time to discharge from the recovery room while maintaining adequate surgical anesthesia.


Condition Intervention
Spinal Anesthesia
Total Knee Arthroplasty
Drug: Low dose bupivicaine in spinal anesthetic
Drug: Standard dose bupivacaine in spinal anesthetic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Low Dose Spinal Bupivacaine for Total Knee Arthroplasty and Recovery Room Wait Time

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Time from spinal injection of bupivicaine until recovery room discharge criteria met. [ Time Frame: Until recovery room discharge post surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Need for pharmacologic rescue from inadequate spinal block during the procedure. [ Time Frame: Until end of surgery ] [ Designated as safety issue: Yes ]
  • Time from entrance into recovery room until criteria for a recovery room discharge are met [ Time Frame: Until recovery room discharge criteria are met ] [ Designated as safety issue: No ]
  • Time from entrance into recovery room until criteria for a femoral nerve block for post-operative pain control are met [ Time Frame: Until criteria are met for post operative nerve block in recovery room ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: October 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I Drug: Low dose bupivicaine in spinal anesthetic
Bupivacaine 9 mg intrathecal single shot injection at start of surgery
Active Comparator: II Drug: Standard dose bupivacaine in spinal anesthetic
Bupivacaine 13 mg intrathecal single shot injection at start of surgery

Detailed Description:

With the doses of bupivacaine currently being used in spinal anesthetics at our institution, patients' sensory blocks are often much higher than needed to achieve adequate surgical anesthesia. This translates into a prolonged waiting period in the recovery room before the level regresses down to the pre-existing standard for discharge to the ward, as well as the pre-existing level before a post-operative nerve block for extended pain relief can be performed. This prolonged period in the recovery room leads to general delays in operating room usage and thus surgical cancellations. The excessive drug doses currently used also put patients at risk for increasing side effects including low blood pressure, slow heart rates, and nausea and vomiting.

By using a reduced dose of bupivacaine in a spinal anesthetic for a one sided knee replacement, we hope to significantly reduce the recovery room waiting times until the criteria for recovery room discharge or completion of a post-operative nerve block are met, while still providing adequate surgical anesthesia.

Patients will receive either 9 mg (intervention dose) or 13 mg (control dose) of bupivacaine through a spinal injection. Once the patients enter the recovery room after surgery the level of their sensory block will be tested as per usual protocol by the recovery room nurses every 15 minutes until a predefined level has been reached, and the two groups will be compared.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing elective one-sided total knee replacement for osteoarthritis at our institution where spinal anesthesia has been chosen by the patient and the anesthetist

Exclusion Criteria:

  • Contraindications to spinal anesthesia (such as increase pressure in brain, bleeding disorder, serious valvular heart disease, serious infection in the blood or on your lower back, certain neurological disorders such as multiple sclerosis, desire for a general anesthetic)
  • Allergies to local anesthetics, morphine or fentanyl
  • Both knees being done at same surgery
  • Revision of a previous knee replacement
  • Knee replacement for reasons other than osteoarthritis (such as rheumatoid arthritis)
  • Potential for difficult intubation in case of need for general anesthetic
  • Patients under 150 cm or over 200 cm
  • BMI greater than 40
  • Lack of patient consent or patient refusal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537472

Locations
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Melanie Jaeger, MD, FRCPSC Staff anesthesiologist at Kingston General Hospital
Study Director: Dale Engen, MD, FRCPSC Staff anesthesiologist at Kingston General Hospital
Study Director: Devin Sydor, MD Anesthesiology resident at Kingston General Hospital/Queen's University
  More Information

No publications provided

Responsible Party: Melanie Jaeger, MD, FRCPC, Queens University and Kingston General Hospital
ClinicalTrials.gov Identifier: NCT00537472     History of Changes
Other Study ID Numbers: 6106
Study First Received: September 28, 2007
Last Updated: April 16, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Queen's University:
Bupivacaine
spinal anesthesia
total knee arthroplasty

Additional relevant MeSH terms:
Anesthetics
Bupivacaine
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014