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临床试验/NCT07264608
NCT07264608尚未招募不适用

Comparison of 4-Point Transversus Abdominis Plane Block and Combined Bilateral Rectus Sheath-Oblique Subcostal TAP Block on Quality of Recovery After Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Konya City Hospital1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2025年12月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
76
试验地点
1
主要终点
Quality of Recovery score (QoR-15)

研究概览

简要总结

Laparoscopic cholecystectomy is a common keyhole surgery to remove the gallbladder. Although the cuts are small, patients can still have significant pain and nausea after the operation, which may delay recovery and discharge. To improve comfort, doctors often use ultrasound-guided abdominal nerve blocks as part of multimodal pain management.

In this single-center, randomized controlled trial, adult patients scheduled for elective laparoscopic cholecystectomy will receive standard general anesthesia and be randomly assigned to one of two routinely used block techniques at the end of surgery: (1) a 4-point transversus abdominis plane (TAP) block, or (2) a combined bilateral rectus sheath block plus oblique subcostal TAP block. Both techniques are performed under ultrasound guidance while the patient is still asleep.

The main aim of the study is to compare the quality of recovery on the first day after surgery between the two groups, using a short questionnaire (QoR-15). Secondary aims are to compare pain scores, the need for additional pain medicine, and the frequency of postoperative nausea and vomiting between the groups during the first 24 hours. All other aspects of anesthesia and surgical care will follow standard hospital practice. Participation is not expected to add significant risk beyond that of routine anesthesia and surgery, as both block techniques are already commonly used in clinical practice.

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
Triple (Participant, Investigator, Outcomes Assessor)

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

  • Adults aged 18-65 years
  • ASA physical status I-II
  • Scheduled for elective laparoscopic cholecystectomy
  • Ability to understand the study and provide written informed consent

排除标准

  • Allergy or hypersensitivity to local anesthetics or study medications
  • Coagulopathy, anticoagulant therapy, or local infection at block site
  • Severe pulmonary disease (severe COPD, uncontrolled asthma, respiratory failure)
  • NYHA class III-IV heart failure
  • History of thoracic or abdominal surgery affecting block area
  • Chronic pain syndrome or regular opioid/analgesic use
  • Morbid obesity (BMI > 35 kg/m²)
  • Pregnancy or breastfeeding
  • Cognitive impairment preventing cooperation
  • Conversion to open cholecystectomy

结局指标

主要结局

Quality of Recovery score (QoR-15)

时间窗: 24 hours

The Quality of Recovery-15 (QoR-15) questionnaire will be used to assess postoperative recovery quality at 24 hours after surgery. The QoR-15 scale ranges from 0 to 150 points, with higher scores indicating better recovery quality.

次要结局

  • Postoperative pain score (VAS)(30 minutes, 2 hours, 8 hours, and 24 hours after surgery.)
  • Incidence of postoperative nausea and vomiting (PONV)(First 24 hours postoperative.)
  • Antiemetic requirement(First 24 hours postoperative.)

研究者

发起方
Konya City Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Esma Karaarslan

Medical Doctor (MD), Department of Anesthesiology and Reanimation, Konya City Hospital

Konya City Hospital

研究点 (1)

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