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Completed

NCT Number: NCT00537472

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low dose bupivicaine in spinal anesthetic

Drug

Bupivacaine 9 mg intrathecal single shot injection at start of surgery

Standard dose bupivacaine in spinal anesthetic

Drug

Bupivacaine 13 mg intrathecal single shot injection at start of surgery

Primary outcomes

  1. Time from spinal injection of bupivicaine until recovery room discharge criteria met.

    Time frame: Until recovery room discharge post surgery

Secondary outcomes

  1. Need for pharmacologic rescue from inadequate spinal block during the procedure.

    Time frame: Until end of surgery

  2. Time from entrance into recovery room until criteria for a recovery room discharge are met

    Time frame: Until recovery room discharge criteria are met

  3. 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

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 1, 2007
Registry last updated
Apr 17, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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