The Effect of Liposomal Bupivacaine on the Quality of Recovery in Patients Undergoing Shoulder Arthroscopy
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Quality of Recovery
研究概览
简要总结
Background:
The research study is being conducted to see if using the liposomal Bupivacaine for the Interscalene block will improve the patient pain control and the whole patient's experience 48 hours after surgery when compared to using the regular Marcaine (bupivacaine hydrochloride) in addition to the dexamethasone.
All preoperative, surgical, post-operative care in the recovery room, and discharge instructions will be the same as any other patient undergoing this surgery.
Study procedures:
- After obtaining informed consent, an anesthesiologist will receive an envelope with result of randomization. Patients will receive a single injection interscalene nerve block prior to surgery
- Patients will be randomized to one of two groups:
- GROUP 1 liposomal Bupivacaine - will receive a 20 ml mixture of 10 ml of Liposomal Bupivacaine 1.3% and 10 ml of Bupivacaine HCl 0.5%.
- GROUP 2 Bupivacaine with dexamethasone - will receive 20 ml of Bupivacaine HCl 0.5% with 4 mg of preservative-free dexamethasone.
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Patients will undergo general endotracheal anesthesia with inhaled anesthetic (Sevoflurane) for a goal MAC 1.0. Other than the aforementioned interscalene nerve block, patients will not receive any other local anesthetic.
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Patients will receive a multimodal analgesic and antiemetic regimen standardized for shoulder arthroscopies at our institution. Preoperatively, all patients will receive 300 mg of gabapentin and 1,000 mg of acetaminophen orally. Intraoperatively, patients will receive 4 mg of ondansetron and 15 mg of ketorolac intravenously. Postoperatively, patients will remain on an oral regimen of 300 mg of gabapentin three times daily for one week, and 1,000 mg of acetaminophen and 10 mg of ketorolac every 8 hours for 48 hours after surgery.
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Additional intraoperative or postoperative opioid analgesics will be administered as needed. Patients with a history of PONV or otherwise deemed high risk for PONV by the attending anesthesiologist will receive a scopolamine patch before induction of general anesthesia.
详细描述
Background:
Shoulder arthroscopy is one of the most commonly performed ambulatory orthopedic procedures in the United States. However, despite advances in arthroscopic technique, significant postoperative pain remains a major challenge in the perioperative period. Regional anesthesia has played a key part in alleviating postoperative pain, particularly the use of single-shot interscalene nerve blocks. However, single-shot blocks are limited by their relatively short duration of action. The use of continuous peripheral nerve catheters is often limited by institutional resources.
As such, adjuvants can be added to the local anesthetic solution to help prolong the single-shot block. Whereas a long-acting local anesthetic such as Bupivacaine HCl can provide analgesia for 8-12 hours when deposited perineurally, the addition of adjuvants such as 4 mg preservative-free dexamethasone has been shown to prolong blocks for up to 24 hours.
Liposomal Bupivacaine (Exparel®, Pacira Pharmaceuticals, Parsippany, NJ) is a novel formulation of Bupivacaine that was approved for interscalene nerve blocks in April 2018.8 By incorporating Bupivacaine within a multivesicular liposomal suspension (DepoFoam®) that causes a slow release of the drug, it is purported to extend a nerve block's analgesic effect to at least 72 hours.9 10 ml of Liposomal Bupivacaine 1.3% (133 mg) is recommended for interscalene blocks; this solution is also often mixed with Bupivacaine HCl to complement early analgesia.
To our knowledge, no study has evaluated the effect of Liposomal Bupivacaine in the context of postoperative quality of recovery. Given the well-known postoperative pain and functional limitations of shoulder arthroscopy, the postoperative Quality of Recovery (QoR) scale is an appropriate tool to capture these outcomes. This scale assesses patient recovery in multiple domains, including physiological, nociceptive, activities of daily living, cognition and patient satisfaction. To date, the QoR scale has been used in over 100 perioperative studies and has been repeatedly validated in the postoperative setting, including ambulatory orthopedic procedures. As they have been validated over the years, the QoR has been correlated to quality of life and patient satisfaction with pain management after surgery, two key components of a successful ambulatory procedure.
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, Outcomes Assessor)
盲法说明
The research assistant collecting the data as well the patient will be blinded to the nature of the group assignments.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •physical ASA status I-III
- •age greater than 18 years
- •mental competency
- •ability to provide informed consent for the study.
排除标准
- •severe pulmonary disease including chronic obstructive pulmonary disease(COPD)
- •home oxygen use
- •a preexisting chronic pain syndrome (defined as daily opioid intake for more than three months prior to surgery)
- •allergies to any of the study medications or any of the medications in the multimodal analgesic regimen
- •an inability to receive a nerve block due to anticoagulation status infection
- •nerve injury
- •patient refusal.
研究组 & 干预措施
GROUP 1 Liposomal Bupivacaine
Will receive a 20 ml mixture of 10 ml of Liposomal Bupivacaine 1.3% and 10 ml of Bupivacaine HCl 0.5%.
干预措施: Liposomal bupivacaine (Drug)
GROUP 2 Bupivacaine with dexamethasone
Will receive 20 ml of Bupivacaine HCl 0.5% with 4 mg of preservative-free dexamethasone.
干预措施: Bupivacaine with Dexamethasone Solution (Drug)
结局指标
主要结局
Quality of Recovery
时间窗: 48 Hours
The primary outcome will be defined as the Quality of Recovery (QoR-15) score at 48 hours after surgery. There are 15 questions assessed on a scale of 0-10, 10 being the better outcome.
次要结局
- Quality of Recovery(1 Week)
- Pain scores(72 hours)
- PACU LOS(1 Day)
- Opioid Use(72 hours)
- PACU Medications(1 Day)
研究者
Nabil Elkassabany
Physician
University of Pennsylvania