Effect of Medial Transversus Abdominis Plane (TAP) Block and Rectus Sheath (RS) Block on Inguinal Hernia Surgery Recovery, a Prospective Randomized Double-blind Study (PRO-RSTAP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Total cumulative opioid consumption (intravenous morphine equivalent dose, mg)
研究概览
简要总结
Inguinal hernia repair is a common surgical procedure, often performed as day-case surgery. Despite standardized surgical techniques, postoperative pain may delay recovery and occasionally lead to unplanned hospital admission.
The PRO-RSTAP study is a prospective, randomized, double-blind clinical trial evaluating whether ultrasound-guided transversus abdominis plane (TAP) block, rectus sheath (RS) block, or their combination improves postoperative recovery after open inguinal hernia surgery. Adult patients undergoing unilateral open inguinal hernia repair are randomized into four groups receiving either combined TAP and RS blocks, TAP block only, RS block only, or placebo blocks , in addition to standard perioperative care.
The primary outcome is total perioperative opioid consumption measured as intravenous morphine equivalents. Secondary outcomes include postoperative pain scores, need for rescue analgesia, postoperative nausea and vomiting, time to discharge, unplanned hospital admission, and chronic postoperative pain during long-term follow-up.
The aim of this study is to determine the individual and combined effects of TAP and RS blocks on postoperative analgesia and recovery in patients undergoing open inguinal hernia repair.
详细描述
This study is a prospective, randomized, double-blind clinical trial evaluating the effects of ultrasound-guided transversus abdominis plane (TAP) block and rectus sheath (RS) block on postoperative recovery after open inguinal hernia surgery. The study uses a 2 × 2 factorial design, with participants randomized into four groups receiving combined TAP and RS blocks, TAP block only, RS block only, or placebo blocks, in addition to standard perioperative care.
The primary outcome is total perioperative opioid consumption measured as intravenous morphine equivalent dose. Secondary outcomes include postoperative pain intensity, need for rescue analgesia, postoperative nausea and vomiting, time to discharge, and unplanned hospital admission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older
- •Elective unilateral open inguinal hernia repair
- •Ability to provide written informed consent
排除标准
- •Emergency surgery
- •Bilateral or recurrent inguinal hernia
- •Contraindication to regional anesthesia or study interventions
- •Known allergy to local anesthetics
- •Inability to comply with study procedures
研究组 & 干预措施
Combined TAP + RS block
Participants receive active TAP block and active RS block in addition to standard perioperative care.
干预措施: Rectus sheath block (active) (Procedure)
Combined TAP + RS block
Participants receive active TAP block and active RS block in addition to standard perioperative care.
干预措施: Transversus abdominis plane block (TAP block) (Procedure)
Combined TAP + RS block
Participants receive active TAP block and active RS block in addition to standard perioperative care.
干预措施: Ropivacaine (Drug)
Combined TAP + RS block
Participants receive active TAP block and active RS block in addition to standard perioperative care.
干预措施: Ultrasound device (Device)
Combined TAP + RS block
Participants receive active TAP block and active RS block in addition to standard perioperative care.
干预措施: Morphine (Drug)
TAP block only
Participants receive active TAP block and placebo RS block in addition to standard perioperative care.
干预措施: Transversus abdominis plane block (TAP block) (Procedure)
TAP block only
Participants receive active TAP block and placebo RS block in addition to standard perioperative care.
干预措施: Placebo nerve block (Procedure)
TAP block only
Participants receive active TAP block and placebo RS block in addition to standard perioperative care.
干预措施: Ropivacaine (Drug)
TAP block only
Participants receive active TAP block and placebo RS block in addition to standard perioperative care.
干预措施: Sodium chloride (Drug)
TAP block only
Participants receive active TAP block and placebo RS block in addition to standard perioperative care.
干预措施: Ultrasound device (Device)
TAP block only
Participants receive active TAP block and placebo RS block in addition to standard perioperative care.
干预措施: Morphine (Drug)
RS block only
Participants receive active RS block and placebo TAP block in addition to standard perioperative care.
干预措施: Placebo nerve block (Procedure)
RS block only
Participants receive active RS block and placebo TAP block in addition to standard perioperative care.
干预措施: Rectus sheath block (active) (Procedure)
RS block only
Participants receive active RS block and placebo TAP block in addition to standard perioperative care.
干预措施: Ropivacaine (Drug)
RS block only
Participants receive active RS block and placebo TAP block in addition to standard perioperative care.
干预措施: Sodium chloride (Drug)
RS block only
Participants receive active RS block and placebo TAP block in addition to standard perioperative care.
干预措施: Ultrasound device (Device)
RS block only
Participants receive active RS block and placebo TAP block in addition to standard perioperative care.
干预措施: Morphine (Drug)
Placebo TAP + Placebo RS
Participants receive placebo transversus abdominis plane (TAP) block and placebo rectus sheath (RS) block in addition to standard perioperative care.
干预措施: Placebo nerve block (Procedure)
Placebo TAP + Placebo RS
Participants receive placebo transversus abdominis plane (TAP) block and placebo rectus sheath (RS) block in addition to standard perioperative care.
干预措施: Sodium chloride (Drug)
Placebo TAP + Placebo RS
Participants receive placebo transversus abdominis plane (TAP) block and placebo rectus sheath (RS) block in addition to standard perioperative care.
干预措施: Ultrasound device (Device)
Placebo TAP + Placebo RS
Participants receive placebo transversus abdominis plane (TAP) block and placebo rectus sheath (RS) block in addition to standard perioperative care.
干预措施: Morphine (Drug)
结局指标
主要结局
Total cumulative opioid consumption (intravenous morphine equivalent dose, mg)
时间窗: Perioperative/Periprocedural
Total cumulative opioid dose administered intraoperatively and postoperatively, converted to intravenous morphine equivalent dose (mg) using standardized equianalgesic conversion factors.
次要结局
- Postoperative pain intensity (Numeric Rating Scale, NRS 0-10)(1 hour and 24 hours after surgery)
- Number of participants requiring rescue analgesia within 24 hours(Up to 24 hours)
- Number of participants with postoperative nausea and/or vomiting(Up to 24 hours)
- Time to fulfillment of discharge criteria(Up to 24 hours)
- Number of participants with unplanned hospital admission within 24 hours(Up to 24 hours)
- Presence of chronic postoperative pain(1 week and 1, 3, 5, and 10 years after surgery)