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临床试验/NCT07113600
NCT07113600尚未招募不适用

A Randomized Comparative Study Between Ultrasound Guided Erector Spinae Plane Block and Ultrasound Guided Iliohypogastric/ Ilioinguinal Nerve Block for Postoperative Pain Relief in Female Patients Undergoing Open Hysterectomy

Kasr El Aini Hospital0 个研究点目标入组 60 人开始时间: 2025年8月1日最近更新:
适应症
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
主要终点
The time to first call for analgesia.

研究概览

简要总结

The goal of this clinical trial is to compare the degree of pain relief between two techniques of regional anesthesia given to ladies undergoing hysterectomy under general anesthesia.

One group of patients will have a local anesthetic injected between muscle layers in their back (ultrasound guided Erector Spinae plane Block).

The other group will have a local anesthetic injected around specific nerves in their abdomen (ultrasound guided Ilio-hypogastric / ilio-inguinal nerve block ).

Researchers will compare the duration of postoperative pain relief , the degree of pain relief and any possible side effects of either techniques.

详细描述

The use of ultrasound for the placement of peripheral nerve blocks has received a great deal of attention in anesthesiology literature as well as clinical practice. Advantages of ultrasound-guided regional anesthesia include easy learning, fast onset, higher success rates, more complete blocks, using lower local anesthetic volumes and more safety. Good postoperative analgesia can prevent morbidity associated with abdominal hysterectomy by allowing pain-free, early ambulation and decreasing the risks of long hospital stay such as thrombo-embolism, and other poor outcomes. Truncal blocks such as transversus abdominis plane (TAP) blocks have seen limited success due to shorter duration and sub-optimal analgesia. The ultrasound (US)-guided erector spinae plane block (ESPB) w gained wide attention as a fast procedure that carries a lower risk of hypotension, can be used in patients with coagulopathy, is easy to perform, and requires less training. It provides extensive, potent unilateral analgesia, is performed by local anesthetic injection in the plane between the erector spinae muscle and the Transverse process of the corresponding vertebra. The local anesthetic diffuses into the para vertebral space through spaces between adjacent vertebrae and blocks both the dorsal and ventral branches of the thoracic spinal nerves. Bilateral ESPB performed at low thoracic levels was recently shown to provide satisfactory analgesia for gynecologic and abdominal surgery.

Abdominal field blocks, such as the ilio-inguinal / ilio-hypogastric (IL-IH) nerve block are well- known as simple ways to give long-lasting pain relief and limit narcotic usage after surgery.

The ilio-inguinal and ilio-hypogastric nerves are T 12 and L 1 branches that supply the inguinal region and run between the internal oblique and transversus abdominis muscles, slightly above the anterior superior iliac spine.

The aim of this study is to compare the analgesic effect of ilio-hypogastric / ilio-inguinal versus erector spine plane block on female patients undergoing open hysterectomy.

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)

盲法说明

Both blocks will be performed after induction of general anesthesia

入排标准

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

入选标准

  • •Adult female patients above the age of 35 years.
  • •American Society of Anesthesiologists (ASA) physical status I-II.

排除标准

  • •Patient refusal.
  • •History of allergy or intolerance to study medications.
  • •Chronic opioid use (>3 months).
  • •Severe renal or hepatic impairment.
  • •Patients with coagulopathy disorders.
  • •Infection at injection sites.

研究组 & 干预措施

ESPB

Active Comparator

Patients will receive bilateral Erector Spinae Plane block using 20ml bupivacaine 0.25% on each side.

干预措施: Nerve Block (Other)

Ilioinguinal/iliohypogastric

Active Comparator

Patients will receive bilateral Iliohypogastric and Ilioinguinal nerve block using 20ml bupivacaine 0.25% on each side.

干预措施: Nerve Block (Other)

结局指标

主要结局

The time to first call for analgesia.

时间窗: The first 12 postoperative hours

The period of time starting from extubation until the patient asks for analgesia in hours.

次要结局

  • postoperative pain score(VAS was assessed at 0, 2, 6, and 12 hours postoperatively.)
  • intraoperative hemodynamic changes(Operative time)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mai Ahmed Ali Mohamed El-sayed

Assistant Professor Of anesthesia

Kasr El Aini Hospital

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