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临床试验/NCT07233603
NCT07233603进行中(未招募)不适用

Comparison of the Effects of Subcostal Transversus Abdominis Plane Block Versus Rectus Sheath Block on Postoperative Pain in Midline Abdominal Incision Laparotomy

Cumhuriyet University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
1
主要终点
Numeric Rating Scale (NRS) Scores

研究概览

简要总结

The aim is to compare the postoperative analgesic effects of Subcostal Transversus Abdominis Plane Block (S-TAP) versus Rectus Sheath Block (RSB) in patients undergoing laparotomy with midline abdominal incision.

详细描述

Patients were divided into two randomized groups: Group 1 (S-TAP group, n=30) and Group 2 (RSB group, n=30). All patients will receive the same standard general anesthesia per hospital protocol. All blocks will be applied with the same ultrasonography and block equipment, and by the same physician. All patients will receive Paracetamol 1gr and Dexketoprofen 50mg intravenous (IV) 10 minutes prior to skin closure. After the surgery was completed, patients in Group 1 will receive subcostal transversus abdominis plane block (S-TAP) with 20 mL of 0.25% bupivacaine bilaterally (with a total volume of 40 mL). Patients in Group 2 will receive rectus sheath block (RSB) with 20 mL of 0.25% bupivacaine bilaterally (with a total volume of 40 mL). Routine analgesic procedure consisting of 3x1gr Paracetamol and 2x50mg Dexketoprofen will be followed postoperatively for 24 hours. Numeric Rating Scale (NRS) will be used to assess postoperative pain on 1st, 6th, 12th, 18th and 24th hours after the surgery. Tramadol 50mg IV will be administered as a rescue analgesic for all patients if NRS score is equal to or higher than 4. Total Tramadol consumption will be calculated.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult patients older than 18 years of age who underwent laparotomy with midline incision under general anesthesia and were American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.

排除标准

  • •patients who did not give consent,
  • •patients with coagulopathy,
  • •patients with signs of infection at the block application site,
  • •patients using anticoagulants,
  • •patients with local anesthetic drug allergies,
  • •patients with unstable hemodynamics,
  • •patients who could not cooperate during postoperative pain assessment
  • •patients who received ileostomy or colostomy

研究组 & 干预措施

S-TAP

Active Comparator

For this group, S-TAP blocks will be performed bilaterally right after the surgery completion with the patients in supine position. For S-TAP, a high frequency linear transducer USG is placed below the xiphoid process, on the linea alba transversely. The probe will then be moved laterally along the costal margin with a slight oblique motion to match the costal arc until the transversus abdominis muscle is visualized under the rectus abdominis muscle. The block needle will be inserted in-plane from inferolateral to superomedial direction, aiming toward the fascial plane between transversus abdominis and rectus abdominis muscles. After negative aspiration and hidrodissection with 1-2 mL of saline and verifying the location of the needle tip, 20 mL of 0.25% bupivacaine will be administered on each side, with a total of 40 mL bilaterally.

干预措施: Subcostal Transversus Abdominis Plane Block (Procedure)

RSB

Active Comparator

For this group, RS blocks will be performed bilaterally right after the surgery completion with the patients in supine position. For RSB, a high frequency linear transducer USG is placed above the umbilicus transversely. The probe will then be moved laterally until the rectus abdominis muscle, its posterior sheath and the peritoneum can be visualized clearly. The block needle will be inserted in-plane from lateral to medial direction, aiming toward the posterior sheath of the rectus abdominis muscle. After negative aspiration and hidrodissection with 1-2 mL of saline and verifying the location of the needle tip, 20 mL of 0.25% bupivacaine will be administered on each side, with a total of 40 mL bilaterally.

干预措施: Rectus Sheath Block (Procedure)

结局指标

主要结局

Numeric Rating Scale (NRS) Scores

时间窗: Postoperative 24 hours

Numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.

Total tramadol consumption

时间窗: Postoperative 24 hours

Postoperative total rescue analgesic need was recorded as "milligram" in unit.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Oguz Gundogdu

Associate Professor

Cumhuriyet University

研究点 (1)

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