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临床试验/NCT04526015
NCT04526015已完成不适用

The Analgesic Effect of Iliohypogastric and Ilioinguinal Nerve Block for Acute and Chronic Pain Relief After Cesarean Section Delivery.Randomized Controlled Study Post

Tanta University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2020年9月20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
64
试验地点
1
主要终点
The total dose of morphine used Patients rescue analgesia within first 24h postoperative

研究概览

简要总结

The increase in CS in recent years makes even a small prevalence of persistent pain after CS a significant burden, both financially and in terms of quality of life, for a large number of otherwise healthy young women. Persistent pain after CS has been shown to be associated with postpartum depression, interferes with daily activities, and causes sleep disturbances, all of which negatively and directly impact the mother. As a result, the care of the baby by the mother is affected negatively.

To adequately control postoperative pain, healthcare providers use a one-size-fits-all multimodal analgesic approach and sensible opioid prescription with monitoring to prevent addiction. The challenge is in tailoring this approach to the outliers who may be opioid tolerant or opioid-sensitive. However, the severity and duration of postoperative pain and its management may be predictive of developing persistent pain at two to 12 months or later.

Previous studies revealed different outcomes regarding the analgesic efficacy of II-IH nerve block for post caesarean pain, inguinal repair and surgery involving the female genital tract. Moreover, exploring the efficacy of II-IH nerve block could help to tackle sever postoperative pain after cesarean delivery particularly in settings where there is shortage of epidural kit supply and availability of strong opioids for pain management. We aimed to assess the analgesic efficacy of bilateral ilioinguinal and iliohypogastric nerve block for planned caesareans delivery under spinal anaesthesia and evaluate the incidence of persistent pain with transition from acute to chronic pain.

详细描述

All patients will be assessed preoperatively by history taking, physical examination, and laboratory evaluation. On arrival of the patients to the operative room, electrocardiography, non-invasive blood pressure and pulse oximetry will be applied.

The patients will be positioned in sitting position to give the spinal anesthesia at L3-L4/L2-L3 intervertebral level in the midline approach. After local infiltration of skin and subcutaneous tissue with 2% lignocaine, 25 G B-braun spinal needle will be used to administer subarachnoid block (SAB) with 2.5 ml of hyperbaric bupivacaine (5%) and 20 µg of fentanyl after confirmation of free flow of cerebrospinal fluid (CSF) at the hub of the needle. Patients will be coloaded with 10-12 ml/kg (over the period of 15 min) of Ringer's Lactate (RL) solution at the time of SAB. Thereafter, patients will be placed in supine position with wedge under the right hip.

64 Patients were randomly allocated into two equal groups (each 32 patients):

  • Group B (IL/IH group): Each patient will receive spinal anesthesia plus bilateral ultrasound-guided IL/IH nerve block. The abdomen will be scanned through anterior superior iliac spine (ASIS)-umbilicus line. Ilioinguinal nerve can be visualized between the internal oblique and transverse or external oblique muscles and within 1 to 3 cm from the ASIS. The iliohypogastric nerve lies immediately adjacent. After negative aspiration (to exclude intravascular injection), 10 mL of 0.25% bupivacaine will be injected. The same technique will be performed on the other side
  • Group C (Controlled group): Each patient will receive spinal anesthesia alone with no block.

Postoperative Analgesia Protocol

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 (Care Provider)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Pregnant female.less than 40 years .
  • •ASA l,ll full term scheduled for elective cesarean section

排除标准

  • •patient refusal
  • •Emergency section
  • •More than I prior section
  • •Current pain disorder
  • •Allergy to local anesthetic
  • •Coagulopathy
  • •Major cardiac,renal, hepatic disorder

研究组 & 干预措施

Ilioinguinal iliohypogastric Block

Experimental

Each patient will receive spinal anesthesia plus bilateral ultrasound-guided IL/IH nerve block. The abdomen will be scanned through anterior superior iliac spine (ASIS)-umbilicus line. Ilioinguinal nerve can be visualized between the internal oblique and transverse or external oblique muscles and within 1 to 3 cm from the ASIS. The iliohypogastric nerve lies immediately adjacent. After negative aspiration (to exclude intravascular injection), 10 mL of 0.25% bupivacaine will be injected. The same technique will be performed on the other side

干预措施: Iliohypogastric and ilioinguinal nerve block (Procedure)

Controlled Group

Other

Each patient will receive spinal anesthesia alone with no block.

干预措施: Controlled Group (Procedure)

结局指标

主要结局

The total dose of morphine used Patients rescue analgesia within first 24h postoperative

时间窗: up to 24 hours postoperative

The total dose of morphine used postoperatively/patient (rescue analgesia) within first 24 h postoperative

次要结局

  • Incidence of chronic pain at 3 & 6 months.(up to 6 months)

研究者

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

Amr Arafa Elbadry

Principal Investigator

Tanta University

研究点 (1)

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