Comparison of Intrathecal Morphine, Transversalis Fascia Plane Block, and Spinal Anesthesia Alone for Postoperative Analgesia in Open Inguinal Hernia Repair: A Prospective, Randomized, Assessor-Blinded, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Morphine Consumption via Patient-Controlled Analgesia
研究概览
简要总结
Inguinal hernia is a common surgical condition, and open inguinal hernia repair may be associated with significant postoperative pain. Inadequate pain control can delay early mobilization, reduce patient comfort, and increase the need for opioid analgesics. Therefore, effective postoperative pain management is an important component of perioperative care.
Several analgesic strategies can be used after open inguinal hernia repair, including systemic multimodal analgesia, neuraxial opioids, and regional anesthesia techniques. Intrathecal morphine can provide prolonged postoperative analgesia but may be associated with opioid-related adverse effects such as nausea, vomiting, pruritus, urinary retention, and respiratory depression. Ultrasound-guided transversalis fascia plane block is a regional anesthesia technique designed to provide analgesia to the inguinal region while potentially reducing systemic opioid requirements.
The aim of this prospective, randomized, assessor-blinded, controlled trial is to compare the postoperative analgesic efficacy of intrathecal morphine, transversalis fascia plane block, and spinal anesthesia alone in adult patients undergoing elective open unilateral inguinal hernia repair.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years
- •American Society of Anesthesiologists physical status I-II-III
- •Body mass index between 18 and 30 kg/m²
- •Patients undergoing elective open inguinal hernia repair
排除标准
- •Patient refusing the procedure
- •History of chronic analgesic or opioid therapy
- •History of local anesthetic and morphine allergy
- •Infection in the intervention area
研究组 & 干预措施
Intrathecal Morphine
Participants will receive spinal anesthesia with 12.5 mg of 0.5% hyperbaric bupivacaine combined with 0.1 mg (100 mcg) of intrathecal morphine, with a total intrathecal volume of 3 mL. No additional peripheral nerve block will be performed. All participants will receive the standardized postoperative multimodal analgesia protocol and intravenous patient-controlled analgesia.
干预措施: Intrathecal Morphine Group (Procedure)
Transversalis Fascia Plane Block
Participants will receive spinal anesthesia with 15 mg of 0.5% hyperbaric bupivacaine (3 mL). At the end of surgery, an ultrasound-guided unilateral transversalis fascia plane block will be performed on the surgical side using 30 mL of 0.25% bupivacaine. All participants will receive the standardized postoperative multimodal analgesia protocol and intravenous patient-controlled analgesia.
干预措施: Transversalis Fascia Plane Block Group (Procedure)
Spinal Anesthesia Alone
Participants will receive spinal anesthesia with 15 mg of 0.5% hyperbaric bupivacaine (3 mL) administered intrathecally. No additional neuraxial opioid or regional block will be performed. All participants will receive the standardized postoperative multimodal analgesia protocol and intravenous patient-controlled analgesia.
干预措施: Control Group (Procedure)
结局指标
主要结局
Morphine Consumption via Patient-Controlled Analgesia
时间窗: Up to 24 hours after surgery
The total amount of intravenous morphine administered via patient-controlled analgesia during the first 24 postoperative hours will be recorded in milligrams (mg) based on the PCA device records.
次要结局
- Pain scores(Up to 24 hours after surgery)
- Total Rescue Tramadol Consumption(Up to 24 hours after surgery)
- Side effects(Up to 24 hours after surgery)
研究者
Musa Zengin
Principal Investigator
Ankara Etlik City Hospital