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

NCT00537472 | Completed

• 1 other identifier: 6106
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Anesthesia; Total Knee Arthroplasty

Keywords

Bupivacaine; spinal anesthesia; total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

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

  Until recovery room discharge post surgery

Secondary Outcomes (3)

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

  Until end of surgery

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

  Until recovery room discharge criteria are met

• 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

Study Arms (2)

I

EXPERIMENTAL

Drug: Low dose bupivicaine in spinal anesthetic

II

ACTIVE COMPARATOR

Drug: Standard dose bupivacaine in spinal anesthetic

Interventions

Low dose bupivicaine in spinal anesthetic DRUG

Bupivacaine 9 mg intrathecal single shot injection at start of surgery

I

Standard dose bupivacaine in spinal anesthetic DRUG

Bupivacaine 13 mg intrathecal single shot injection at start of surgery

II

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

MeSH Terms

Interventions

Anesthesia, Spinal; Bupivacaine

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Melanie Jaeger, MD, FRCPSC

  Staff anesthesiologist at Kingston General Hospital

  PRINCIPAL INVESTIGATOR

• Dale Engen, MD, FRCPSC

  Staff anesthesiologist at Kingston General Hospital

  STUDY DIRECTOR

• Devin Sydor, MD

  Anesthesiology resident at Kingston General Hospital/Queen's University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 28, 2007
• First Posted: October 1, 2007
• Study Start: October 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: April 17, 2009

Record last verified: 2009-04

Locations

CA (1)