Opioid Consumption in Patients Undergoing Arthroscopic Rotator Cuff Repair Using Interscalene Brachial Plexus Blocks With and Without Liposomal Bupivacaine: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Duration of Opioid Use
研究概览
简要总结
The investigators aim to determine if a longer acting nerve block, which is a local anesthetic, can help reduce opioid use after surgery in patients that are getting rotator cuff repair surgery. The investigators will also determine if the longer acting block can reduce the number of days that opioids are taken after surgery. Patients that schedule this type of surgery will be given information regarding the study and asked if they want to participate. If they do, they will be randomized to either receive the standard nerve block or the longer acting nerve block. Participants and physicians will not know which nerve block the participants are receiving. Participants will receive a standard pain medication prescription after surgery and will be asked to record pain scores, medications taken and satisfaction level every day in a journal for two weeks. Participants will be asked to bring in their medication bottles and pain journal to the 2-week follow up appointment. Participants' pain scores will be assessed in the office at the follow up appointment and study staff will conduct a pill count. Participants will return for a 6-week follow up appointment and pain scores will be assessed again at that time, and another pill count will be conducted. At this point the study will be complete.
详细描述
- Patients who have an Arthroscopic Rotator Cuff Repair (ARCR) scheduled to be performed at Roanoke Ambulatory Surgery Center (RASC) by one of the participating surgeons will be prescreened, assessed for eligibility and consented at the pre-operative visit.
- This office visit already includes: a formatted discussion regarding the risks, benefits and alternatives to surgery; fitting for a sling; and a review of the opioid policy and patient agreement used by Carilion Clinic's Institute for Orthopaedics and Neurosciences (ION).
- The PI or sub-investigators will conduct the discussion regarding the rational and use of Interscalene Brachial Plexus Block (ISB) with the procedure, the rationale for assessment of alternate medications used for the study and any other pertinent details. An approved research team member will review all sections of the IRB approved research consent in detail, in person at the pre-operative visit. All questions will be answered and physical signatures will be obtained. Both research groups, control and experimental, will sign the same consent document. A copy of the signed consent will be provided to the participant.
- All participants will be given a pain diary to take home and begin filling out the day following their surgery. Per participant preference, pain diary may be physical copy or done electronically via REDCap.
- All participants will be instructed on how to record entries in the pain diary by an approved research team member. The pain diary will have templated pages with areas to record the amounts and names of medications they consumed, their Numerical Rating Scale (NRS) score, their Intervention Based Pain Scale (IBPS) score, as well as satisfaction levels and a place to record how long their anesthetic block lasted.
- Participants in both study groups will be provided the same information and education regarding postoperative pain management protocol and expectations. This includes:
- A review of the opioid policy and patient agreement used by Carilion Clinic's ION as well as a discussion about proper use of the pain medication to be prescribed for postoperative pain management
- A discussion regarding the ISBs used with the procedure and their likely duration of analgesia
- A discussion of scheduled postoperative visits and how to contact the office with questions/concerns regarding recovery
- The investigators will use the random number generator feature in REDcap to randomly assign subjects to receive the standard Bupivacaine HCl ISB or the Exparel ISB. Surgery schedules at RASC are released on Friday the week before. The investigators will retrieve the surgery schedule on Fridays from RASC, find study subjects, and randomize them to group A (Exparel) or group B (Bupivacaine HCl) that same day (the Friday before surgery). Once the subjects are randomized, the investigators will communicate the randomization to a RASC staff member and they will put the arm designation (group A or group B) in an envelope and attach it to the subject's chart for the day of surgery. The contents of the envelope will only be seen by Anesthesia providers and charge nurses prior to the surgery with no other study staff in the room (so the blind is not broken). Charge nurses and anesthesiologists at RASC will be unblinded to the definitions of groups A & B to gather and administer the proper medications. Surgeons will not be in the room at the time of anesthetic administration. The patient and all other providers including physicians and physician assistants will be blinded to the result of the randomization. Participants may opt to be unblinded to their group assignment at their 6-week post operative visit.
- All participants will be undergoing a routine ARCR. The procedure will not deviate from the standard of care operation that is typically performed. All participants will receive an ultrasound-guided ISB by a pool of anesthesia providers at RASC. The only difference between subject groups is that the control group will receive a standard Bupivacaine HCl ISB and the experimental group will receive an Exparel ISB.
- On the day of surgery all participants will be brought to the pre-operative holding area at RASC where they are seen prior to the surgical procedure by both the operating surgeon and the anesthesiologist. The operating surgeon will review the surgical procedure with all participants and will mark the side and location of the procedure. The anesthesiologist will review the ISB procedure with the participant and ensure correct side and location marked by physician. Before the anesthesiologist begins administration of the ISB, an anesthesia time-out is performed with the anesthesiologist and the participant to confirm patient identity, surgical site, and planned procedure.
- In the pre-operative holding area or the operating room, the anesthesiologist will position all participants in the recumbent position with a slight roll onto the opposite side from the block and will administer a local infiltration of the skin with 1-2mL of Bupivacaine HCl 0.5% (dosages may vary based on participant size and pain threshold). If participants are unable to sit still during ISB administration, they may be sedated by the anesthesiologist with one of the following (Medications and dosages vary based on need):
- Versed
- Fentanyl
- Propofol
- Administration of the standard Bupivacaine HCl ISB for the control arm goes as follows:
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, Care Provider)
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
- •At least 18 years of age at time of enrollment
- •Be scheduled for Arthroscopic Rotator Cuff Repair (ARCR) surgery with associated pathology (CPT code 29827 + associated codes)
- •Be scheduled for ARCR surgery for primary repair
- •Be scheduled for ARCR surgery to be performed at Roanoke Ambulatory Surgery Center (RASC) by a surgeon participating in the study
- •Is willing to fill out the pain diary
- •Is able to read, understand, and sign the informed consent document
- •Is able to read and understand the patient-reported measures that will be collected via the pain diary and phone calls
排除标准
- •American Society of Anesthesiologists (ASA) status IIIb or greater.
- •ASA status III is characterized by:
- •A patient with severe systemic disease, e.g., Substantive functional limitations; One or more moderate to severe diseases. Examples include (but not limited to): poorly controlled DM or HTN, COPD, morbid obesity (BMI ≥40), active hepatitis, alcohol dependence or abuse, implanted pacemaker, moderate reduction of ejection fraction, ESRD undergoing regularly scheduled dialysis, premature infant PCA < 60 weeks, history (>3 months) of MI, CVA, TIA, or CAD/stents.
- •According to Dr. TK Miller and Anesthesiologists at RASC, there is an unwritten standard that patients characterized as ASA status III that have stable, long term disease can be operated on at free-standing ambulatory surgery centers. Broken down into ASA IIIa and ASA IIIb.
- •ASA IIIa represents ASA status III patients that are assessed by anesthesia and deemed stable enough to operate on at a free-standing ambulatory surgery center.
- •ASA IIIb represents ASA status III patients that are assessed by anesthesia and deemed not stable enough to operate on at a free-standing ambulatory surgery center.
- •Examples of individuals that would classify as ASA IIIa include:
- •Someone who has a history of longstanding diabetes that is well managed.
- •Someone who is status post cardiac stent(s) and has had no chest pain or angina since the stents have been placed and has been cleared by their cardiologist to go back to full activity.
- •Examples of individuals that would classify as ASA IIIb include:
- •Someone who has a history of longstanding diabetes that is poorly managed.
- •Someone who is status post cardiac stent(s) and has had chest pain or angina since the stents have been placed and has not been cleared by their cardiologist to go back to full activity.
- •Currently pregnant
- •Documented opioid use within 30 days prior to surgery
- •Revision ARCR surgery
- •Currently taking opioid medication for chronic pain management
- •History of documented substance abuse or related disorders
- •Currently enrolled or planning to enroll in another clinical trial during this study that would affect the outcome of this study
- •Allergic reactions to amide anesthetics
- •Neurologic deficit or disability involving the surgical extremity
- •Unwilling or unable to consent
- •History of cognitive or mental health status that would interfere with study participation
研究组 & 干预措施
Control - Standard Bupivacaine
After proper positioning and local infiltration, a linear high-frequency ultrasound transducer will be placed on the anteromedial aspect of the neck, approximately 2 cm above the clavicle, and the interscalene brachial plexus will be identified between the anterior and middle scalene muscles. After sterile preparation of the skin, a 22-gauge needle will be inserted in-plane from the lateral aspect of the transducer and directed through the middle scalene muscle. The needle will be advanced until the tip is observed just lateral to the brachial plexus sheath. After negative aspiration, 20mL of 0.5% bupivacaine will be injected in 5mL increments, followed by 20mL of 0.25% bupivacaine injected in 5mL increments. The injection will be administered slowly with periodic aspiration, with the needle being adjusted using ultrasound guidance as the ISB is injected to surround the brachial plexus trunks (upper, middle and lower) that are seen at the interscalene level of injection.
干预措施: Bupivacaine Hcl 0.25% Inj (Drug)
Experimental - Liposomal Bupivacaine (Exparel)
After proper positioning and local infiltration, a linear high-frequency ultrasound transducer will be placed on the anteromedial aspect of the neck, approximately 2 cm above the clavicle, and the interscalene brachial plexus will be identified between the anterior and middle scalene muscles. After sterile preparation of the skin, a 22-gauge needle will be inserted in-plane from the lateral aspect of the transducer and directed through the middle scalene muscle. The needle will be advanced until the tip is observed just lateral to the brachial plexus sheath. After negative aspiration, 20mL of 0.5% bupivacaine will be injected in 5mL increments, followed by 20mL of Exparel injected in 5mL increments. The injection will be administered slowly with periodic aspiration, with the needle being adjusted using ultrasound guidance as the ISB is injected to surround the brachial plexus trunks (upper, middle and lower) that are seen at the interscalene level of injection.
干预措施: Liposomal bupivacaine (Drug)
结局指标
主要结局
Duration of Opioid Use
时间窗: Total 6 week duration of study
How long the patients took opioid medications for postoperatively (in hours)
Total Opioid Use
时间窗: 6 week
Total opioid pills consumed, converted to milligram of morphine equivalents (MME)
NRS Pain Scores
时间窗: Total 6 week duration of study
Pain scores on the Numerical Rating Scale, 1-10 with 1 being no pain and 10 being the worst pain imaginable
IBPS Pain Scores
时间窗: Total 6 week duration of study
Pain scores on our Intervention Based Pain Scale, proprietary scale developed by Dr. TK Miller at Carilion Clinic. Patient has 6 options to choose from (unnumbered), that will be assigned a numeric value upon analysis. Scale ranges from 1-6, with lower scores representing more manageable (less severe) pain and higher scores representing less manageable (more severe) pain.
次要结局
- Patient Satisfaction via Likert scale(2 weeks postoperatively)
- Duration of Nerve Block(Within 5 days postoperatively)
研究者
Thomas K Miller
M.D., Section Chief, Sports Medicine
Carilion Clinic