A Randomised Comparison Between Combined Femoral Triangle Block+IPACK Block and Femoral Triangle Block for Anterior Cruciate Ligament Reconstruction Analgesia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Post-operative pain scores at 2 hours of arrival to Post Anesthesia Care Unit (PACU)
研究概览
简要总结
An adequate balance between analgesia and motor function is an essential requirement to facilitate functional recovery and early discharge after anterior cruciate ligament (ACL) reconstruction surgery.
Proximal nerve blocks (i.e. femoral and sciatic nerve blocks) are associated with optimal analgesia, but they can cause muscle weakness, interfering with rehabilitation and increasing the risk of falls .
A recent randomized controlled trial concluded that, compared to mid-and distal ACB, a distal femoral triangle block (FTB) is associated with lower opioid consumption and improved postoperative analgesia for ambulatory ACL reconstruction.
In ACL reconstruction surgery there are other potential sources of pain not covered by a FTB, such as intra-articular structures (menisci, cruciate ligaments), posterior knee capsule and the graft donor site.
Evidence supporting the addition of an IPACK block to a FTB has been studied for patients undergoing total knee replacement, nonetheless, there is no trial analyzing the analgesic contribution of IPACK to a FTB in the context of ACL reconstruction surgery.
In this multicentric trial, the investigators set out to analyze the analgesic benefit of adding an IPACK block to a FTB.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Patient scheduled to undergo anterior cruciate ligament reconstruction under general anesthesia with ipsilateral autologous graft.
- •Age between 18 and 65 years
- •American Society of Anesthesiologists classification 1-3
- •Body mass index between 19 and 35 (kg/m2)
排除标准
- •Adults who are unable to give their own consent
- •Pre-existing neuropathy (assessed by history and physical examination)
- •Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
- •Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
- •Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
- •Allergy to local anesthetics (LAs), morphine or tramadol
- •Pregnancy
- •ACL revision surgery
- •Contralateral graft or any type of allograft
- •Chronic pain syndromes requiring opioid intake at home
研究组 & 干预措施
Femoral Triangle + IPACK block
Patients randomized to receive a combination of femoral triangle block and active IPACK block
干预措施: Bupivacaine Injection (Drug)
Femoral Triangle block
Patients randomized to receive a combination of femoral triangle block and sham IPACK block
干预措施: normal Saline (Drug)
结局指标
主要结局
Post-operative pain scores at 2 hours of arrival to Post Anesthesia Care Unit (PACU)
时间窗: 2 hours after arrival to PACU
Pain evaluated during knee flexion in Numeric Rating Score from 0 to 10 points
次要结局
- Post-operative static pain scores at 6 hours of arrival to PACU(6 hours after arrival to PACU)
- Nerve block complications(From nerve block performance up to 24 hours after PACU arrival)
- Lower limb tourniquet(from inflation of pneumatic device to tourniquet release)
- Post-operative dynamic pain scores at PACU discharge(at discharge of PACU up to 2 hours postoperatively)
- Post-operative dynamic pain scores at 12 hours of arrival to PACU(12 hours after arrival to PACU)
- Post-operative dynamic pain scores at 24 hours of arrival to PACU(24 hours after arrival to PACU)
- Incidence of opioid related adverse events(24 hours after arrival to PACU)
- Total opioid consumption(6 hours, 12 hours and 24 hours after PACU arrival)
- Post-operative static pain scores at 0 hours of arrival to PACU(0 hours after arrival to PACU)
- Post-operative static pain scores at PACU discharge(at discharge of PACU up to 2 hours postoperatively)
- Post-operative static pain scores at 12 hours of arrival to PACU(12 hours after arrival to PACU)
- Post-operative static pain scores at 24 hours of arrival to PACU(24 hours after arrival to PACU)
- Post-operative dynamic pain scores at 0 hours of arrival to PACU(0 hours after arrival to PACU)
- Post-operative dynamic pain scores at 6 hours of arrival to PACU(6 hours after arrival to PACU)
- Femoral Triangle Block success assessment at 2 hours(2 hours after arrival to PACU)
- Intraoperative opioid consumption(From anesthesia induction to extubation)
- PACU opioid consumption(from PACU arrival to discharge up to 2 hours postoperatively)
研究者
Sebastian Layera
Assistant Professor
University of Chile