Ultrasound-guided Bi-level Erector Spinae Plane Block and Pre-emptive Single-dose Oral Tizanidine for Postoperative Analgesia After Mastectomy Surgery: a Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- First analgesic request
研究概览
简要总结
Effective management of postoperative pain in breast cancer surgery is essential to minimize the risk of developing postmastectomy pain syndrome.The aim of this study is to evaluate the effectiveness of combining bilevel erector spinae plane (ESP) block with a single preoperative oral dose of tizanidine in improving postoperative analgesia in patients undergoing mastectomy surgery.
It is hypothesized that the combination of bilevel ESP block and single-dose oral tizanidine will provide superior postoperative analgesia compared to bilevel ESP block alone in patients undergoing mastectomy.
详细描述
Introduction:
Effective management of postoperative pain in breast cancer surgery is essential to minimize the risk of developing postmastectomy pain syndrome, a chronic condition that significantly impacts patients' quality of life. Multimodal analgesia, which combines pharmacological and non-pharmacological strategies, has been shown to enhance postoperative pain control and reduce opioid consumption. In recent years, regional anesthesia techniques have become increasingly favored for perioperative pain management in breast surgeries. The ESP block has gained popularity due to its simplicity, safety profile, and effectiveness in thoracic and breast surgeries. Its analgesic action is attributed to the craniocaudal spread of local anesthetic into the costovertebral foramina and epidural space, resulting in blockade of both ventral and dorsal rami of the spinal nerves and providing unilateral thoracic analgesia.The bilevel ESP block, which involves administering the block at two distinct thoracic levels, has been proposed to enhance the spread of local anesthetic and improve analgesic coverage, particularly in the anterolateral chest wall and axillary regions commonly involved in mastectomy.
Tizanidine has been shown to reduce perioperative opioid and anesthetic requirements, stabilize hemodynamic responses to tracheal intubation, and minimize postoperative complications such as shivering and myocardial ischemia. Previous studies have demonstrated its effectiveness in reducing postoperative pain across a variety of surgical procedures, including laparoscopic cholecystectomy, thyroidectomy, anorectal surgery, hernia repair, and orthognathic surgery.Given the potential synergistic effects of combining regional anesthesia with systemic analgesics, this study aims to evaluate the efficacy of combining bilevel ESPB with a single oral dose of tizanidine for postoperative pain control in patients undergoing mastectomy.
Aim of the Study:
The aim of this study is to evaluate the effectiveness of combining bilevel erector spinae plane (ESP) block with a single preoperative oral dose of tizanidine in improving postoperative analgesia in patients undergoing mastectomy 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 (Participant, Outcomes Assessor)
盲法说明
A single investigator will assess the patients for eligibility, obtain written informed consent, open the sealed opaque envelopes containing group allocation, prepare all injections and oral medication needed for the study. Another investigator blinded to the study group will give oral drug and perform block. In addition, the study subjects and the resident assessing the outcome will be blinded to the study group.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiology (ASA) ІІ patients.
- •Scheduled for unilateral modified radical mastectomy.
- •BMI levels between 18.5- 35 Kg/m2.
排除标准
- •Patient's refusal.
- •Altered mental status or un-cooperative patients.
- •History of known sensitivity to the used anesthetics.
- •Bleeding or coagulation diathesis.
- •Infection or redness at the injection site.
- •Cardiac, renal, hepatic, hematological disease, peptic ulcer, gastrointestinal bleeding, and central or peripheral neurological disease.
- •Chronic pain.
- •Participants used analgesics routinely within the last 24 h.
研究组 & 干预措施
Bilevel ESP block group
patients will have bilevel ESP block plus oral placebo capsule.
干预措施: Bilevel erector spinae plane block (Procedure)
Bilevel ESP block group
patients will have bilevel ESP block plus oral placebo capsule.
干预措施: Placebo Oral Capsule (Drug)
Bilevel ESP block + tizanidine group
patients will have bilevel ESP block plus oral tizanidine capsule.
干预措施: Bilevel erector spinae plane block (Procedure)
Bilevel ESP block + tizanidine group
patients will have bilevel ESP block plus oral tizanidine capsule.
干预措施: tizanidine oral capsule (Drug)
结局指标
主要结局
First analgesic request
时间窗: Up to 24 hours after the procedure.
The time of the first analgesic request for fentanyl will be recorded.
次要结局
- Visual analogue score (VAS) for pain assessment(Up to 24 hours after the procedure)
- Total analgesic requirements of fentanyl(Up to 24 hours after the procedure)
- Heart rate (HR)(Up to the end of the procedure)
- Mean arterial blood pressure (MAP)(Up to the end of the procedure)
- Adverse effects(Up to 24 hours after the procedure])
研究者
Amany Hazem abdelmaksood EL-deeb
principle investigator
Mansoura University