Clinical trial NCT00537472: Low Dose Spinal Bupivacaine for Total Knee Replacement and Recovery Room Wait Time
Official title: Low Dose Spinal Bupivacaine for Total Knee Arthroplasty and Recovery Room Wait Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Anesthesia
Total Knee Arthroplasty
Keywords: Bupivacaine
spinal anesthesia
total knee arthroplasty
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2007-10-01
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Time from spinal injection of bupivicaine until recovery room discharge criteria met.
timeFrame: Until recovery room discharge post surgery
Secondary outcomes:
measure: Need for pharmacologic rescue from inadequate spinal block during the procedure.
timeFrame: Until end of surgery
measure: Time from entrance into recovery room until criteria for a recovery room discharge are met
timeFrame: Until recovery room discharge criteria are met
measure: Time from entrance into recovery room until criteria for a femoral nerve block for post-operative pain control are met
timeFrame: Until criteria are met for post operative nerve block in recovery room
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
Study officials:
affiliation: Staff anesthesiologist at Kingston General Hospital
name: Melanie Jaeger, MD, FRCPSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Staff anesthesiologist at Kingston General Hospital
name: Dale Engen, MD, FRCPSC
role: STUDY_DIRECTOR
affiliation: Anesthesiology resident at Kingston General Hospital/Queen's University
name: Devin Sydor, MD
role: STUDY_DIRECTOR
References: