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

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00537472
• Other study ID #: 6106
• Status: Completed
• Phase: N/A
• First received: September 28, 2007
• Last updated: April 16, 2009
• Start date: October 2007
• Est. completion date: December 2008

Study information

• Verified date: April 2009
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Anesthesia
• Total Knee Arthroplasty

Intervention

Drug:
• Low dose bupivicaine in spinal anesthetic
Bupivacaine 9 mg intrathecal single shot injection at start of surgery
• Standard dose bupivacaine in spinal anesthetic
Bupivacaine 13 mg intrathecal single shot injection at start of surgery

Locations

Country	Name	City	State
Canada	Kingston General Hospital	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from spinal injection of bupivicaine until recovery room discharge criteria met.		Until recovery room discharge post surgery	No
Secondary	Need for pharmacologic rescue from inadequate spinal block during the procedure.		Until end of surgery	Yes
Secondary	Time from entrance into recovery room until criteria for a recovery room discharge are met		Until recovery room discharge criteria are met	No
Secondary	Time from entrance into recovery room until criteria for a femoral nerve block for post-operative pain control are met		Until criteria are met for post operative nerve block in recovery room	No