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临床试验/NCT07321639
NCT07321639已完成不适用

Comparison of the Effectiveness of Ultrasound-Guided Recto-Intercostal Fascial Plane Block and Transversus Abdominis Plane Block in Postoperative Analgesia Management of Patients Undergoing Laparoscopic Cholecystectomy

Istanbul Medipol University Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年1月19日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Opioid consumption

研究概览

简要总结

Ultrasound (US)-guided recto-intercostal fascial plane block (RIFPB) is a recently described abdominal wall block performed by injecting local anesthetic between the rectus abdominis muscle and the costal cartilage of the 7th rib. Due to the cranial attachment of the rectus muscle, this technique provides effective analgesia to the sternal, epigastric, and upper-mid abdominal regions, corresponding to the T6-T10/11 dermatomal levels. RIFPB may be used as an adjunct technique for thoracic procedures or as a standalone block for abdominal surgery.

Ultrasound-guided transversus abdominis plane block (TAPB) is performed by injecting local anesthetic into the fascial plane between the internal oblique and transversus abdominis muscles. TAPB provides sensory blockade of the anterolateral abdominal wall at the T6-L1 dermatomal levels and is widely used for postoperative analgesia following abdominal surgeries, including laparoscopic cholecystectomy.

This study aims to compare the effectiveness of US-guided RIFPB and TAPB on postoperative pain control after laparoscopic cholecystectomy.

详细描述

Laparoscopic cholecystectomy is one of the most commonly performed abdominal surgical procedures. Postoperative pain after laparoscopic cholecystectomy is multifactorial and may result from trocar site incisions, visceral manipulation, peritoneal irritation, and diaphragmatic stimulation due to pneumoperitoneum. Various analgesic strategies, including systemic opioids, non-opioid analgesics, local anesthetic infiltration, and regional anesthesia techniques, are used to manage postoperative pain in these patients.

Ultrasound (US)-guided recto-intercostal fascial plane block (RIFPB) is a recently described regional anesthesia technique that provides analgesia to the sternal, epigastric, and upper-mid abdominal regions by targeting the fascial plane between the rectus abdominis muscle and the costal cartilage. RIFPB provides sensory blockade at the T6-T10/11 dermatomal levels and has been reported to be effective for postoperative analgesia in thoracic and upper abdominal procedures. Due to its anatomical spread and mechanism of action, RIFPB may offer effective analgesia following laparoscopic cholecystectomy.

Ultrasound-guided transversus abdominis plane block (TAPB) is a well-established regional anesthesia technique performed by injecting local anesthetic between the internal oblique and transversus abdominis muscles. TAPB provides analgesia to the anterolateral abdominal wall at the T6-L1 dermatomal levels and is commonly used for postoperative pain control after various abdominal surgeries, including laparoscopic cholecystectomy.

In this study, the investigators aim to compare the effectiveness of US-guided RIFPB and TAPB for postoperative pain management after laparoscopic cholecystectomy and to compare both techniques with a control group.

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

Outcomes assessor and participants will be blinded to the study

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA physical status I-II
  • Scheduled for elective laparoscopic cholecystectomy

排除标准

  • Known allergy to local anesthetics or opioid medications
  • Infection at the planned block site
  • History of alcohol or drug dependence
  • Use of anticoagulant therapy
  • Refusal to participate in the study

研究组 & 干预措施

Transversus abdominis plane block

Active Comparator

TAP block will be performed, and standard postoperative pain management protocols will be applied.

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

Control group

Active Comparator

Standard postoperative pain management protocols will be applied. No plane block will be applied.

干预措施: Post-operative Pain Management (Other)

Recto-intercostal fascial plane block

Active Comparator

RIFP block will be performed, and standard postoperative pain management protocols will be applied.

干预措施: Recto-Intercostal Fascial Plane Block (Procedure)

Recto-intercostal fascial plane block

Active Comparator

RIFP block will be performed, and standard postoperative pain management protocols will be applied.

干预措施: Post-operative Pain Management (Other)

Transversus abdominis plane block

Active Comparator

TAP block will be performed, and standard postoperative pain management protocols will be applied.

干预措施: Post-operative Pain Management (Other)

结局指标

主要结局

Opioid consumption

时间窗: During the first 24 hours postoperatively

Total postoperative opioid consumption will be recorded for each patient during the first 24 hours after surgery. Opioid use will be quantified based on the total dose of rescue opioid analgesics administered and compared between study groups to assess differences in postoperative opioid requirements.

次要结局

  • Postoperative pain scores(Postoperative hours 1, 3, 6, 12, 18, and 24.)
  • Adverse events(During the first 24 hours postoperatively)
  • Postoperative Rescue Analgesic Consumption:(During the first 24 hours postoperatively)

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayse Ince

Assistant Professor

Istanbul Medipol University Hospital

研究点 (1)

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