Postoperative Analgesic Benefit of iPACK Block in the Anterior Cruciate Ligament Reconstruction Surgery, the LIGA-PACK Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Cumulative opioid consumption at 48 hours after surgery
研究概览
简要总结
This randomised clinical trial evaluates the analgesia provided by an iPack block associated with an adductor canal block in patients who undergo anterior cruciate ligament reconstruction surgery, compared to an adductor canal block alone. The objective is to prove the superiority of this locoregional anesthesia in terms of analgesia and functional rehabilitation.
详细描述
The ideal loco-regional anesthesia for anterior cruciate ligament reconstruction ensuring a satisfying analgesia without compromising an early rehabilitation is still undetermined.
Femoral nerve block has been incriminated in a delayed postoperative mobilization whereas the adductor canal block gives an equivalent analgesia for a better preservation of the quadricipital muscular strength.
The iPACK block (infiltration between the popliteal artery and the capsule of the posterior knee) is a recently described technique. Few studies have assessed the iPACK block in ACL reconstruction, and none were randomized.
This randomized single blind clinical trial compares two groups of 45 patients who undergo ACL reconstruction surgery under general anaesthetic : one receives an iPACK block associated with an adductor canal block, and the other only has an adductor canal block.
Pain scores and opioid consumption are collected after surgery in the recovery room, then by telephone interview at 24 and 48 hours post-surgery. Functional rehabilitation is evaluated by scales (KOOS, LYSHOLM and iKDC) at 3, 6 and 9 months after surgery. Adverse effects, due to anesthesia or opioids, are collected from 30 min after loco-regional anesthesia until the second phone call at 48h post-surgery.
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
- Single (Participant)
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
- •Age ≥ 18 years
- •ACL repair surgery under general anesthesia
- •Person affiliated or beneficiary of a social security plan
- •Free, informed and written consent
排除标准
- •Age < 18 years
- •Contraindication to ALR (allergy to local anesthetics, local infection of the puncture site, coagulopathy)
- •Pre-existing opiate dependence
- •Contraindication to non-steroidal anti-inflammatory drugs
- •Pregnant or potentially pregnant women
- •Patients under the protection of adults (guardianship, curatorship or safeguard of justice)
- •Patients whose cognitive state does not allow evaluation by the scales used
研究组 & 干预措施
adductor canal block
loco-regional analgesia with adductor canal block (ACB) method (for anterior cruciate ligament reconstruction )
干预措施: adductor canal block (Procedure)
iPACK block
loco-regional analgesia with iPACK block (infiltration between the popliteal artery and the capsule of the posterior knee) ((for anterior cruciate ligament reconstruction )
干预措施: iPACK block (Procedure)
结局指标
主要结局
Cumulative opioid consumption at 48 hours after surgery
时间窗: Hours 48
Cumulative opioid consumption in the first 48 hours after anterior cruciate ligament repair surgery
次要结局
- Maximum pain score at 48 hours after surgery(hours 48)
- Maximum pain score in the recovery room(hours 2)
- Maximum pain score at 24 hours after surgery(hours 24)
- Cumulative opioid consumption at 2 hours after surgery(Hours 2)
- Cumulative opioid consumption at 24 hours after surgery(Hours 24)
- Cumulative opioid consumption at 3 months(month 3)