Ultrasound-guided Erector Spinae Plane Block Versus Local Wound Infiltration in Breast Conservative Surgery, Randomized Double Blinded Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Total amount of morphine consumed postoperatively for 24 hours.
研究概览
简要总结
Abstract
Background:
Postoperative pain management is a crucial component of patient care following breast conservative surgery. This study compares the efficacy of ultrasound-guided Erector Spinae Plane Block (ESPB) and Local Wound Infiltration (LWI) in managing acute postoperative pain in these surgeries.
Objectives:
This randomized, double-blinded, controlled clinical trial aims to compare the analgesic efficacy and safety of ultrasound-guided ESPB and LWI in patients undergoing breast conservative surgery.
Patients and methods:
Adult female patients (aged 18-75, ASA II) scheduled for breast conservative surgery were randomly assigned to either the ESPB or LWI group. The primary outcome was total morphine consumption in the first 24 hours postoperatively. Secondary outcomes included; intraoperative fentanyl consumption, hemodynamic parameters (mean arterial blood pressure and heart rate), time of first rescue analgesia, postoperative pain scores, the incidence of postoperative nausea and vomiting (PONV) and patient satisfaction. Complications such as local anesthetic toxicity and respiratory depression were also assessed.
Key Words:
Erector Spinae Plane Block (ESPB), Local wound infiltration, Postoperative analgesia, Breast conservative 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 75 years.
- •Genders eligible for study: females.
- •Patients scheduled for breast conservative surgery.
- •Ability to provide informed consent or, if unable, consent obtained from a legal representative
排除标准
- •Patient refusal.
- •Inability to provide informed consent.
- •ASA III-IV.
- •Known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).
- •Pregnant or lactating women.
- •History of psychological disorders and/or chronic pain. 25
- •Contraindication to regional anesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
- •Severe respiratory or cardiac disorders.
- •Advanced liver or kidney disease.
- •Male patients.
结局指标
主要结局
Total amount of morphine consumed postoperatively for 24 hours.
时间窗: up to 24 hours postoperative
Total amount of morphine consumed postoperatively for 24 hours (mg/kg)
次要结局
- Total amount of fentanyl consumed intraoperatively(Perioperative/Periprocedural)
- Hemodynamics: heart rate intraoperatively at 30-minute intervals in comparison to baseline readings.(Perioperative/Periprocedural)
- Mean arterial blood pressure at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.(at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.)
- The visual analog scale (VAS) (at rest and during movement) at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.(at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.)
- Postoperative nausea and vomiting (PONV) as side effects of morphine.(up to 24 hours postoperative)
- Time of first rescue analgesia intra-operative (Fentanyl)(up to 24 hours postoperative)
- Time of first rescue analgesia post-operative (Morphine)(up to 24 hours postoperative)
- Complications such as local anaesthetic systemic toxicity, pneumothorax and arterial puncture. (US check postoperative).(up to 24 hours postoperative)
- Morphine related complications such as respiratory depression, urine retention or pruritic(up to 24 hours postoperative)
- Total amount of fentanyl consumed intraoperatively(Perioperative/Periprocedural)
- Hemodynamics: heart rate intraoperatively at 30-minute intervals in comparison to baseline readings.(Perioperative/Periprocedural)
- Hemodynamics: mean arterial blood pressure intraoperatively at 30-minute intervals in comparison to baseline readings.(Perioperative/Periprocedural)
- Heart rate at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.(at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.)
- Mean arterial blood pressure at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.(at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.)
- The visual analog scale (VAS) (at rest and during movement) at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.(at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.)
- Postoperative nausea and vomiting (PONV) as side effects of morphine.(up to 24 hours postoperative)
- Time of first rescue analgesia intra-operative (Fentanyl)(up to 24 hours postoperative)
- Time of first rescue analgesia post-operative (Morphine)(up to 24 hours postoperative)
- Complications such as local anaesthetic systemic toxicity, pneumothorax and arterial puncture. (US check postoperative).(up to 24 hours postoperative)
- Morphine related complications such as respiratory depression, urine retention or pruritic(up to 24 hours postoperative)
- Patient satisfaction the patient will be classified in this group into satisfied or not.(up to 24 hours postoperative)
研究者
Tasneem Hassan El-Tohamy
Dr
Cairo University