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临床试验/NCT06155253
NCT06155253已完成不适用

Comparing Analgesic Efficacy and Quality of Recovery of Bi-level and Single-level Erector Spinae Plane Block for Open Inguinal Hernia Repair Surgery - a Randomised, Observed-blinded Active-controlled Trial

Hospital Authority, Hong Kong1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年1月15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
发起方
入组人数
90
试验地点
1
主要终点
Post-operative pain score

研究概览

简要总结

The goal of this clinical trial is to compare the effects of single-level and bi-level erector spinae plane block in open inguinal hernia repair surgery. The main question it aims to answer are:

  • Whether bi-level ESP block will improve pain control after open inguinal hernia repair surgery
  • Whether bi-level ESP block will improve quality of recovery after open inguinal hernia repair surgery

Participants will receive erector spinae plane block, and will be randomised into 2 groups, single-level ESP block and bi-level ESP block, before open hernia repair surgery. They will be followed up after operation for assessment of pain control and quality of recovery.

详细描述

Open inguinal hernia repair is increasingly performed as a day case surgery. As a result, satisfactory acute pain control is very important to reduce discomfort, as well as to facilitate early mobilisation and recovery. Regional anaesthesia, eg. erector spinae plane block (injection below para-spinal muscles) is increasingly implemented as part of multi-modal analgesia to establish better post-operative pain control and spare the use of opioids which can lead to unwanted side effects eg. sedation, nausea and vomiting. Acute post-surgical pain from open inguinal hernia repair consists of subcutaneous, deep somatic and visceral components. The erector spinae plane (ESP) block acts by local anaesthetic (LA) spread to ventral and dorsal rami of spinal nerves, producing somatic and visceral pain relief. Therefore, it can effectively relieve acute post-surgical pain resulted from open hernia repair. Bi-level ESP block has been utilised clinically to provide multi-dermatomal analgesia in pain management eg. flail chest; or anaesthetic management eg. open inguinal hernia repair, scoliosis surgery, mastectomy. However, to date, there have been no studies comparing the analgesic efficacy of bi-level and single-level erector spinae plane blocks. The investigators postulate that comparing with single-level ESP block, bi-level ESP block can facilitate LA spread into paraspinal areas more effectively, producing more reliable analgesia; and therefore would reduce post-operative pain scores and improve quality of recovery in patients undergoing open inguinal hernia repair.

To investigate the above clinical question, a parallel-group observer-blinded randomised clinical trial was designed. Patients will be randomised into 2 groups. One group of patients (2ESP) will receive ESP block at ipsilateral T12 and L1; while the other group of patients (1ESP) will receive ESP block at ipsilateral L1. L1 was chosen as an injection level, since it is at the midpoint of corresponding spinal nerve roots innervating the groin (T12-L3). For bi-level injection group, thoracic instead of another lower lumbar level was chosen to avoid motor blockade caused by excessive local anaesthetic spread into lumbar plexus, leading to delayed mobilisation which is undesirable for patients undergoing ambulatory 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
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Patients above 18 years old
  • ASA (American Society of Anesthesiologists) class I to III
  • Unilateral open inguinal hernia repair

排除标准

  • Patient refusal or unable to consent to study
  • Contraindication of ESP block including patient refusal, injection site infection, coagulopathy, hypersensitivity to local anaesthetic
  • Pre-existing chronic pain
  • Alcohol and substance dependence
  • Pre-existing psychiatric diseases

研究组 & 干预措施

Single-level ESP group (1ESP)

Active Comparator

Subjects in 1ESP group will receive a single-shot single-level erector spinae plane block at L1 level under ultrasound guidance immediately before surgery.

干预措施: Erector spinae plane block (Procedure)

Bi-level ESP group (2ESP)

Active Comparator

Subjects in this group will receive a single-shot single-level erector spinae plane block at T12 and L1 levels under ultrasound guidance immediately before surgery.

干预措施: Erector spinae plane block (Procedure)

结局指标

主要结局

Post-operative pain score

时间窗: 1 day

Numeric rating score (11-point scale) will be used to assess pain. (0 = no pain, 10 = worst pain)

Quality of recovery score (QoR-15)

时间窗: 1 day

This is a validated questionnaire to evaluate the physical, emotional and functional aspects of patients and their abilities to resume usual activities of daily living after surgery and anaesthesia. It ranges from 0-150. Higher score indicates better recovery.

次要结局

  • Time to first rescue analgesic(1 day)
  • Rate of motor deficit(1 day)
  • Peri-operative fentanyl dosage(1 day)
  • Rate of post-operative nausea and vomiting(2 days)
  • Rate of post-operative urinary retention(2 days)

研究者

发起方
Hospital Authority, Hong Kong
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Patricia Ip

Resident

Hospital Authority, Hong Kong

研究点 (1)

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