Low Dose Spinal Bupivacaine for Total Knee Arthroplasty and Recovery Room Wait Time
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Time from spinal injection of bupivicaine until recovery room discharge criteria met.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
I
干预措施: Low dose bupivicaine in spinal anesthetic (Drug)
II
干预措施: Standard dose bupivacaine in spinal anesthetic (Drug)
结局指标
主要结局
Time from spinal injection of bupivicaine until recovery room discharge criteria met.
时间窗: Until recovery room discharge post surgery
次要结局
- 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)