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临床试验/NCT07480499
NCT07480499尚未招募不适用

Comparative Efficacy of Erector Spinae Plane and Quadratus Lumborum Blocks in Managing Postoperative Pain for Total Abdominal Hysterectomy: A Randomized Controlled Trial

Sheikh Khalifa Bin Zayed Al Nahyan Combined Military Hospital Muzaffarabad1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年4月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Post Operative Pain

研究概览

简要总结

TAH, being a large scale gynaecological operation, is a construction bound to cause serious postoperative pain to the patient in that the procedure will inevitably entail massive tissue dissection. Management of this postoperative pain is of utmost significance because poor analgesia may lead to delayed mobilization of the patient, long duration of hospitalization and also general increase in the morbidity of postoperative period. Traditionally, in these facilities, opioid analgesics are the most common and the most popular means of controlling postoperative pain. Nevertheless, the varied and pervasive use of opioids is largely constrained by its well-reported, dose-dependent systemic adverse effects. Nausea, vomiting, sedation, and respiratory depression are complications that severely degrade the recovery process of the patient and reduce his or her satisfaction.

详细描述

Patients who met the inclusion criteria were recruited in the trial after getting approval from the Hospital Ethical Review Committee and REU CPSP. Demographic information such as age, height, weight, body mass index as well as the functional classification (ASA) was documented on a pre-made proforma. Patients were randomized into two groups using a computer-generated randomisation process.

Group A: Received an ultrasound-guided erector spinae plane block at the T9-T10 level using 20 ml of 0.25% bupivacaine.

Group B: Received an ultrasound-guided posterior quadratus lumborum block using 20 ml of 0.25% bupivacaine.

A qualified anaesthesiologist performed each block in aseptic settings prior to surgery. Standardised general anaesthesia was administered to each patient. The Visual Analogue Scale (VAS) was used to quantify pain at rest and on coughing at 2, 6, 12, 18, and 24 hours. Patents with VAS score more than 4, were given rescue analgesia and the cumulative amount of analgesics used in the first 24 hours as well as the time of the first rescue analgesia were recorded. Patient satisfaction with pain treatment as well as adverse effects such nausea, vomiting, and hypotension were tracked for a duration of 24 hours after the surgery

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
35 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients aged 35-60 years. ASA physical status I or II. Elective Total Abdominal Hysterectomy under General Anesthesia.

排除标准

  • Allergy with local anesthetics. Infection in the injection site. Coagulopathy or anticoagulant use. Morbid obesity (BMI > 35 kg/m²).

研究组 & 干预措施

Group A

Active Comparator

干预措施: Erector Spinae Plane Block (Procedure)

Group B

Active Comparator

干预措施: Quadratus Lumborum Block (QLB) (Procedure)

结局指标

主要结局

Post Operative Pain

时间窗: 24 Hours

Visual Analogue Score a one-dimensional indicator of pain severity. It is made up of a horizontal line that is 10 cm (100 mm) long and has two end points marked "No Pain" (0) and "Worst Possible Pain" (10). On the line, the patient marks the point that most accurately depicts their level of discomfort at 2,4,6,18 \& 24 hours post operatively.

次要结局

  • Time to first Rescue Analgesia(24 Hourse)
  • Cumulative Opioid consumption(24 Hours)
  • Adverse effects(24 Hours)
  • Patient Satisfaction(24 Hours)

研究者

发起方
Sheikh Khalifa Bin Zayed Al Nahyan Combined Military Hospital Muzaffarabad
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hamid Altaf

Resident

Sheikh Khalifa Bin Zayed Al Nahyan Combined Military Hospital Muzaffarabad

研究点 (1)

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