The Effects of Subcostal Transversus Abdominis Plane Block and Port-site Infiltration on the Quality of Recovery of Patients Undergoing Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Quality of Recovery-15 (QoR-15) scale
研究概览
简要总结
This clinical trial aims to compare the Quality of Recovery-15 (QoR-15) scale scores in three groups of patients undergoing laparoscopic cholecystectomy. The first group will be applied subcostal transversus abdominis plane (subcostal TAP) block, the second group will receive local anesthetic infiltration into port sites, and the third group will receive only IV analgesics.
详细描述
There are current approaches that search patients' perspectives to assess postoperative outcomes. In this regard, patient-centered outcomes are evaluated in clinical trials. It is recommended that patient comfort be assessed for short-term recovery after surgery. The Quality of Recovery-15 (QoR-15) scale is a defined patient comfort endpoint. This scale is a 15-item questionnaire that evaluates postoperative recovery as a patient-centered outcome. Each item is rated between 1 and 10, and the total score changes between 0 and 150. Improved recovery is associated with higher scores.
The subcostal transversus abdominis plane ( Subcostal TAP) block is used for analgesia in abdominal surgeries, including laparoscopic cholecystectomy. Local anesthetics are injected between the rectus abdominis and transversus abdominis muscles along the oblique subcostal line. Local anesthetic infiltration into the laparoscopic port sites is also used for analgesia in laparoscopic cholecystectomy.
The primary outcome of this study is to evaluate the effects of subcostal TAP block and port-site infiltration on the quality of recovery of patients undergoing laparoscopic cholecystectomy. Secondary outcomes are to evaluate Numerical Rating Scale (NRS) scores at time intervals, postoperative rescue analgesic requirement, total consumption of postoperative opioid analgesics, and presence of nausea and vomiting, for the postoperative 24 hours.
This study will be conducted as a prospective randomized clinical trial. The patients scheduled for elective laparoscopic cholecystectomy will be screened for enrollment in the study. After assessment for eligibility, the patients will be randomly allocated into three groups.
For the first group, a subcostal TAP block will be applied after intubation and before surgery. A local anesthetic solution of 20 ml 0.25% bupivacaine for each side will be injected bilaterally between the rectus abdominis and transversus abdominis muscles along the oblique subcostal line. For the second group, after intubation and before port placements, a solution of 20 ml 0.25% bupivacaine will be infiltrated into the laparoscopic port sites. The third group will not have an intervention or local anesthetic administration, and a multimodal routine IV analgesic regimen will be administered intraoperatively (1 gr paracetamol, 8 mg lornoxicam and 1mg/kg tramadol). This IV analgesic regimen will be applied to all patients included in the study. The patients will not know to which group they are allocated. Standard anesthesia protocol will be applied to all patients.
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, Care Provider, Outcomes Assessor)
盲法说明
The subcostal TAP block and port-site infiltration will be applied after the patient has general anesthesia, so the patient will not know the allocated group. The healthcare providers who work in the ward and are responsible for the analgesic treatments will be blinded to the patient's group. The outcomes assessor who will question the QoR-15 scale at the 24th hour will also be blinded.
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
- •Patients scheduled for elective laparoscopic cholecystectomy
- •Patients aged 18 to 80
- •American Society of Anesthesiology (ASA) physical status I-II
- •Signed informed consent
排除标准
- •Patient refusal and inability to provide informed consent
- •Known allergy to local anesthetics
- •Severe kidney or liver disease
- •Altered level of consciousness
- •Inability to communicate due to language barrier
- •Diagnosis of mental or psychiatric disorder
- •Presence of coagulation disorder
- •Contraindications to regional anesthesia
- •Contraindications to any drug applying in the study
- •Presence of coagulation disorder
- •Chronic opioid intake
- •Body mass index (BMI) ≥ 40 kg/m2
- •History of alcohol or drug abuse
- •Changed surgical technique from laparoscopic to open.
结局指标
主要结局
Quality of Recovery-15 (QoR-15) scale
时间窗: 24 hours
Quality of Recovery-15 scale is a 15-item questionnaire that evaluates postoperative recovery as a patient-centered outcome. Each item is rated between 0 and 10, and the total score changes between 0 and 150. Improved recovery is associated with higher scores. Postoperative score at the 24th hour will be assessed as the primary outcome.
次要结局
- Numerical Rating Scale (NRS) scores(24 hours)
- Postoperative nausea and vomiting(24 hours)
- Consumption of postoperative opioid analgesics(24 hours)
- Postoperative rescue analgesic requirement(24 hours)
研究者
Muserref Beril Dincer
Medical Doctor, Anesthesiologist
Istanbul University
