Comparison of Ultrasound-Guided Transversalis Fascia Plane Block and Low-Dose Intrathecal Morphine for Postoperative Analgesia After Open Inguinal Hernia Repair: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Total Rescue Opioid Consumption During the First 24 Postoperative Hours
研究概览
简要总结
Open inguinal hernia repair is commonly associated with early postoperative pain, which may delay mobilization, reduce patient satisfaction, and increase opioid consumption. Low-dose intrathecal morphine may provide prolonged postoperative analgesia after spinal anesthesia; however, it may also be associated with opioid-related adverse effects such as nausea, vomiting, pruritus, urinary retention, sedation, and respiratory depression.
The transversalis fascia plane block is an ultrasound-guided fascial plane block that targets the sensory innervation of the lower abdominal wall, particularly the T12-L1 dermatomal region and the ilioinguinal and iliohypogastric nerve distribution. Although TFP block has been evaluated in lower abdominal procedures, direct comparison with low-dose intrathecal morphine in open inguinal hernia repair is limited.
This prospective, randomized, controlled, assessor-blinded trial aims to compare ultrasound-guided TFP block with low-dose intrathecal morphine in adult patients undergoing elective unilateral open inguinal hernia repair under spinal anesthesia. The primary outcome is total rescue opioid consumption during the first 24 postoperative hours. Secondary outcomes include pain scores at rest and with movement, time to first rescue analgesia, opioid-related adverse effects, quality of recovery, patient satisfaction, mobilization time, readiness for discharge, block success, sensory block distribution, and block-related complications.
详细描述
Adult patients scheduled for elective unilateral open inguinal hernia repair under spinal anesthesia will be enrolled. After written informed consent, eligible patients will be randomly assigned in a 1:1 ratio to one of two groups.
In the intrathecal morphine group, patients will receive spinal anesthesia with 15 mg of 0.5% hyperbaric bupivacaine plus 100 mcg intrathecal morphine. No TFP block will be performed in this group.
In the TFP block group, patients will receive spinal anesthesia with 15 mg of 0.5% hyperbaric bupivacaine without intrathecal morphine. In addition, an ultrasound-guided unilateral TFP block will be performed on the surgical side before surgery using 30 mL of 0.25% bupivacaine, within the maximum safe dose limits.
All patients will receive a standardized multimodal postoperative analgesia protocol. Pain scores, rescue analgesic consumption, opioid-related adverse effects, quality of recovery, and safety outcomes will be recorded during the first 24 postoperative hours. Persistent or chronic postoperative inguinal pain may be evaluated exploratorily during follow-up if sufficient data are available.
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)
盲法说明
The outcomes assessor who records postoperative pain scores, rescue analgesic consumption, opioid-related adverse effects, quality of recovery, and follow-up outcomes will be blinded to group allocation. The anesthesiologist performing spinal anesthesia or the TFP block cannot be blinded because of the nature of the interventions
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
- •Adult patients aged 18-80 years
- •Patients scheduled for elective unilateral open inguinal hernia repair
- •ASA physical status I-III
- •Patients planned to undergo spinal anesthesia
- •Patients able to understand and report postoperative pain scores
- •Patients who provide written informed consent
排除标准
- •Refusal to participate
- •Bilateral inguinal hernia repair
- •Recurrent inguinal hernia repair
- •Emergency, incarcerated, or strangulated hernia
- •Need for general anesthesia
- •Contraindication to spinal anesthesia
- •Coagulopathy or anticoagulant use contraindicating neuraxial or peripheral block
- •Infection at the injection site
- •Known allergy to local anesthetics, morphine, or study medications
- •Chronic opioid use
- •Preoperative chronic groin pain or neuropathic pain history
- •Severe hepatic or renal failure
- •Neurological or psychiatric condition preventing communication or pain assessment
- •Expected inability to complete postoperative follow-up
研究组 & 干预措施
TFP Block Group
An ultrasound-guided unilateral transversalis fascia plane block will be performed using 30 mL of 0.25% bupivacaine on the surgical side before open inguinal hernia repair. The local anesthetic dose will be adjusted according to patient weight and maximum safe dose limits.
干预措施: Ultrasound-guided transversalis fascia plane block (Procedure)
Intrathecal Morphine Group
Patients will receive spinal anesthesia with 15 mg of 0.5% hyperbaric bupivacaine plus 100 mcg intrathecal morphine. No TFP block will be performed.
干预措施: Intrathecal morphine (Drug)
结局指标
主要结局
Total Rescue Opioid Consumption During the First 24 Postoperative Hours
时间窗: 0-24 hours after surgery
Total rescue opioid analgesic consumption during the first 24 postoperative hours will be recorded and converted to intravenous morphine equivalents.
次要结局
- Quality of Recovery Score(24 hours after surgery)
- Opioid-Related Adverse Effects(0-24 hours after surgery)
研究者
Sibel Onen Ozdemir
Principal Investigator
Hitit University