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临床试验/NCT06842342
NCT06842342已完成不适用

The Analgesic Effect of Ultrasound-guided Sacral Erector Spinae, Pericapsular Nerve Block and Lumber Plexus Block for Pain Relief for Hip Surgery: Randomized Controlled Study

Tanta University2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年1月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
2
主要终点
Morphine consumption over 24 hours

研究概览

简要总结

The aim of this study to evaluate the effect of The analgesic effect of Ultrasound-guided Sacral erector spinae, Pericapsular nerve block and Lumber Plexus block for pain relief after hip surgery.

The primary outcome will be the collective morphine consumption on the 1st day post-operatively.

Secondary end points Early postoperative pain scores including static pain and passive movement pain (at PACU, at 6 ,12,18 and 24 h after surgery) will be evaluated with visual analog scale (VAS) ranging from 0 to 10, where 0 means no pain and 10 means the worst pain Intraoperative consumption of fentanyl Intraoperative adverse reactions (hypotension, bradycardia, etc.) Complications related with anesthesia (local anesthetic systemic toxicity, pneumothorax, hematoma, etc.) Performance time of block (defined as the time from ultrasound scanning to the end of injection)

详细描述

The hip joint connects the femur and pelvis and is responsible for multidimensional motion and mechanical stability [ 1 ]. Most hip pain is caused by the joint capsule [ 2 ]. Furthermore, the joint is largely controlled by the femoral, sciatic, and obturator nerves [ 3 ]. Patients may experience incomplete analgesia with techniques such as femoral nerve (FN) block alone due to the proximal locations of these nerves. Blocking the proximal innervation of all terminal branches innervating the hip joint (femoral, sciatic, obturator, etc.) causes significant weakness in the leg [ 1 ]. With the growth of the elderly population, more patients are undergoing hip surgeries. However, although methods are improving, no gold standard has been established for anesthesia or, more specifically, for analgesia in operations with high morbidity and high mortality [4]. Hip surgeries include hip arthroplasty (HA) (partial hip replacement, total hip replacement) and proximal femur operations (proximal femoral nailing) [5]. In fact, HA is one of the most successful orthopedic procedures in terms of improving patients' functional status and quality of life [ 6 ]. Appropriate pain management for surgical patients contributes to early mobilization, shorter hospital stays, reduced costs, and increased patient satisfaction.

Therefore, minimizing postoperative pain has become increasingly important for healthcare providers in recent years [ 7 ]. For this purpose, various analgesia techniques have been used. Although opioids typically provide effective pain relief, their use is limited due to serious side effects [ 8 ]. In recent years, peripheral nerve blocks (PNBs) have been used in the management of postoperative pain following hip surgery. The 2021 procedure-specific postoperative pain management (PROSPECT) guideline for total HA recommends several perioperative interventions to alleviate postoperative pain [9].

Erector spinae plane (ESP) block and pericapsular nerve group (PENG) block are the main safe and proven blocks used in hip operations [ 10 , 11 ]. PENG block is a novel regional analgesia technique that preserves motor function while reducing pain after HA. This technique involves injecting local anesthetic (LA) into the fascial plane between the psoas muscle and the superior pubic ramus [ 11 , 12 ].

Erector spinae plane block (ESPB) was first described as an interfascial plane block performed at the upper thoracic levels to alleviate neuropathic pain [13]. Later, its use has been reported in many thoracic procedures including mastectomy, video-assisted thoracoscopy (VATS), heart surgery, at lumbar levels for abdominal surgery, prostatectomy, lumbar spine surgery, total hip arthroplasty, and proximal femur surgery [14].

Sacral ESPB has been recently described. Case reports are showing that it is useful in various types of surgery. In case presentations, it has been reported as effective in providing analgesia in the posterior branches of the sacral nerves in pilonidal sinus surgery, in the treatment of radicular pain at the L5 - S1 level, after a sex reassignment operation hypospadias surgery, and its use in combination with lumbar ESPB for analgesia was reported after hip prosthesis surgery [15-20].

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients aged between 18 and 75 years old without cognitive dysfunction
  • •Body mass index (BMI) between 18.5 and 30 kg/m 2 and the weight ≥ 50 kg
  • •American Society of Anesthesiologists (ASA) classification I-II

排除标准

  • •Refuse to general anesthesia (GA) with tracheal intubation
  • •Nerve block is contraindicated due to various reasons, such as open trauma, hematoma or skin infection at the blocking area, lower limb neuro-muscular disorders
  • •Coagulation dysfunction or anticoagulation therapy
  • •Known hypersensitivity or allergy to local anesthetics

研究组 & 干预措施

Group LPB

Active Comparator

干预措施: Lumber plexus block (Procedure)

Group ESB

Active Comparator

干预措施: Erector Spinae (ESP) Block with Bupivacaine (Marcaine®) (Procedure)

Group PENG

Active Comparator

干预措施: PENG Block (Procedure)

结局指标

主要结局

Morphine consumption over 24 hours

时间窗: 24 hours postoperatively

will be the collective morphine consumption on the 1st day post-operatively

次要结局

  • Pain score(During and after operation within 24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Zakarea Wfa

Lecturer of Anesthesia, Surgical ICU and Pain Medicine

Tanta University

研究点 (2)

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