Comparison of the Effect of Erector Spina Plane Block and Intraperitoneal Local Anesthetic Infiltration on the Quality of Postoperative Recovery in Patients Undergoing Laparoscopic Cholecystectomy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Quality of postoperative recovery
研究概览
简要总结
Laparoscopic cholecystectomy is a commonly performed intra-abdominal surgical procedure all over the world. It may take an average of 4-5 weeks for patients to return to their pre-operative quality of life and standards after this surgery. Both Erector Spinae Plane Block and Intraperitoneal Local Anesthetic Infiltration method are methods used to reduce postoperative pain. However, there is no study in the literature comparing these 2 methods in terms of postoperative recovery quality. In this study, patients will receive Erector Spinae Plane Block or Intraperitoneal Local Anesthetic Infiltration at the end of surgery, and both techniques will be compared using the preoperative and postoperative quality of recovery 40 survey.
详细描述
The Preoperative Quality of Recovery 40 questionnaire will be administered to patients scheduled for laparoscopic cholecystectomy who consent to participate in the study. Following the surgical procedure, patients will receive either intraperitoneal local anesthetic infiltration or bilateral erector spinae plane block for postoperative analgesia. These interventions will be examined in an observational study comprising two distinct groups. At the 24-hour mark postoperatively, the Quality of Recovery 40 (QoR 40) survey will be readministered to the patients, and the outcomes will be subjected to comparative analysis. Throughout the postoperative period, patients in both cohorts will be closely monitored. Pain scores and opioid-associated adverse effects (such as nausea, vomiting, and pruritus) will be assessed at the 1st, 2nd, 4th, 8th, 12th, and 24th hours. Subsequent to the surgical procedure, patients in both groups will be provided with morphine via patient-controlled analgesia, and the extent of opioid consumption within the first 24 hours postoperatively will be compared.
Primary purpose: To compare the effects of Erector Spina Plane (ESP) block and intraperitoneal local anesthetic infiltration on the quality of postoperative recovery in patients undergoing laparoscopic cholecystectomy.
Secondary objectives: To compare the effects of ESP block and intraperitoneal local anesthetic infiltration on postoperative pain scores at rest and with movement, total opioid consumption, and incidence of opioid-related side effects in patients undergoing laparoscopic cholecystectomy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Will undergo laparoscopic cholecystectomy operation,
- •Patients with an American Society of Anesthesiologists Physical Status Score (ASA-PS) of 1, 2 and 3 will be included.
排除标准
- •Patients who do not give consent
- •Those who are allergic to the drugs used in the research
- •Those with coagulation disorders
- •Having a history of alcohol and substance use
- •Having a history of serious psychiatric and neurological diseases
- •Having chronic pain syndrome
- •Those with local infection in the area to be blocked
- •Patients with sepsis and undergoing emergency surgery
结局指标
主要结局
Quality of postoperative recovery
时间窗: postoperative 24th hour
The aim of this study was to use the Quality of Recovery 40 questionnaire as a method to evaluate and compare the effects of Erector Spinae Plane (ESP) block and intraperitoneal local anesthetic infiltration on the quality of postoperative recovery in patients undergoing laparoscopic cholecystectomy. The QoR-40 questionnaire is a self-assessment questionnaire used to evaluate the quality of postoperative recovery. It is a questionnaire that evaluates the level of pain, physical and emotional status of patients and consists of 40 questions and five domains: emotional status (n=9), comfort (n=12), psychological support (n=7), physical independence (n=5) and pain (n=7). Each question is scored on a 5-point Likert scale ranging from 1 to 5. The total score ranges from 40 (worst quality of recovery) to 200 (best quality of recovery). A low total score indicates poor quality of recovery; a high total score indicates good quality of recovery.
次要结局
- Postoperative pain(Postoperative 1st-2nd-4th-8th-12th-24th hours)
- Postoperative opioid consumption(for 24 hours postoperatively)
研究者
Hakan Duzla MD
Research Assistant
Ankara University