Prospective Evaluation of Exparel Adductor Canal Field Block for Pain Control After Anterior Cruciate Ligament Reconstruction
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total opioid consumption
研究概览
简要总结
This is a prospective, randomized study for adult patients presenting to the Carilion Clinic Institute of Orthopedics and Neurosurgery. Patients undergoing isolated ACL reconstruction will be eligible for inclusion. All patients will receive an adductor canal block (either with bupivacaine or Exparel. Patients will be given a pain diary for self-report of pill counts, pain scores, block duration, and pain control satisfaction). Pill counts and pain scores will also be taken by a team member at two and six-week post-operative visits. Primary outcomes include opioid requirements and pain scores.
详细描述
Patients who have an isolated anterior cruciate ligament reconstruction scheduled to be performed at Roanoke Ambulatory Surgery Center (RASC) by one of the participating Carilion 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; 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 rationale and use of adductor canal block (ACB) 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 on post-op day #1 (POD#1). Per patient 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, and will be instructed to record entries daily. The pain diary will have templated pages with areas to record the amounts and names of medications they consumed, Numeric Rating Scale (NRS) score, Intervention Based Pain Scale (IBPS) score, as well as satisfaction levels and a place to record how long their anesthetic block lasted. NRS responses will be indicated by circling a number ranging from 0 (no pain) to 10 (worst pain imaginable). IBPS responses will be indicated by asking patients to check a box next to the statement that best describes their pain management that day. A numerical score will be associated with responses ranging from 1-6. Patient satisfaction will be asked regarding their pain management for the day on a 5-point likert scale ranging from very dissatisfied to very satisfied. Field block duration will be recorded in hours.
All participants will be provided the same information and education regarding postoperative pain management protocol and expectations.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Surgeons and patients will be blinded to study arm until 2 week post-operative visit. Anesthesiology and their staff will not be blinded.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years old
- •Presenting to Carilion Clinic Institute of Orthopedics and Neuroscience
- •Receiving an isolated, first-time ACL reconstruction
- •Operation to be performed at the Roanoke Ambulatory Surgery Center
排除标准
- •Prior opioid use within 30 days of operation
- •Under 18 or over 65 years old
- •Use of opioids for chronic pain management
- •Patients with multi-ligament injuries
- •Patients who are receiving a revision of a previously reconstructed ACL
- •Patients with an allergy to the study drug(s)
- •Patients not medically eligible for surgery
- •Women who are pregnant
研究组 & 干预措施
Exparel/Intervention group
Will receive 10mL of standard 0.5% bupivacaine followed by 10mL of liposomal bupivacaine as adductor canal field block preoperatively
干预措施: Liposomal bupivacaine (Drug)
Exparel/Intervention group
Will receive 10mL of standard 0.5% bupivacaine followed by 10mL of liposomal bupivacaine as adductor canal field block preoperatively
干预措施: Bupivacaine Hydrochloride (Drug)
Standard of Care group
Will receive 20mL of standard 0.5% bupivacaine as adductor canal field block preoperatively
干预措施: Bupivacaine Hydrochloride (Drug)
结局指标
主要结局
Total opioid consumption
时间窗: 6 weeks post-operatively
Total amount of opioids taken by each patient
次要结局
- Pain control quantified by numerical rating scale(2 weeks post-operatively)
- Block length(Self reported anytime from immediately post-op until 2 weeks post-operatively. Likely 1-3 days)
- Pain control quantified by intervention-based pain scale(2 weeks post-operatively)