The Quality of Recovery After Intrathecal Morphine or Adductor Canal Block Added to Spinal Anesthesia in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 24-hour Quality of Recovery-40 (QoR-40) questionnaire scores
研究概览
简要总结
The Quality of Recovery 40 (QoR-40) is a multidimensional questionnaire that addresses many aspects of postoperative recovery. The QoR-40 has been used many times to measure the recovery of patients after different surgeries, and this questionnaire seems to be a reliable tool for evaluating anesthesia-related techniques, including regional anesthesia. Arthroscopic knee surgery causes moderate to severe postoperative pain for most patients. Various methods such as different systemic drugs, peripheral or central blocks and intra-articular injections have been developed for the effective, safe and long-term control of this pain. In recent years, it has been shown that regional anesthesia techniques reduce the need for opioids in orthopedic ambulatory surgeries and accelerate recovery and discharge. However, there is no consensus on which is the best approach among these various regional techniques. However, adductor canal block (ACB) and intrathecal morphine (ITM) are the preferred regional methods in the perioperative pain management of knee surgery. In this study, it was aimed to test the effectiveness of intrathecal morphine or adductor canal block added to spinal anesthesia on the quality of recovery in patients undergoing arthroscopic anterior cruciate ligament reconstruction surgery.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I or II adult patients aged 18-65 years undergoing elective arthroscopic anterior cruciate ligament reconstruction will be included in the study.
排除标准
- •We will exclude patients with known coagulopathy, allergies to the studied drugs, obesity (BMI >35kg/m2), renal and/or hepatic insufficiency, chronic pain syndrome, mental impairment, depression, chronic alcoholism, and usage of antidepressant and analgesic drugs before surgery.
研究组 & 干预措施
Intrathecal morphine (Group ITM)
12.5-15 mg hyperbaric 0.5% bupivacaine + 0.1 mg (0.1 mL) morphine with a single dose intrathecal injection through the L4-L5 interval (spinal anesthesia) + placebo adductor canal block (with 30 mL saline) will be administered.
干预措施: Intrathecal morphine (Drug)
Adductor canal block (Group ACB)
Spinal anesthesia from L4-L5 interval with 12.5-15 mg hyperbaric 0.5% bupivacaine + adductor canal block (30 mL 0.25% bupivacaine) will be applied.
干预措施: Adductor canal block (Drug)
结局指标
主要结局
24-hour Quality of Recovery-40 (QoR-40) questionnaire scores
时间窗: Postoperative 24-hour.
The score ranges from 40 to 200. A higher score on the QoR-40 means better recovery following arthroscopic anterior cruciate ligament reconstruction.
次要结局
- Treatment satisfaction(Postoperative 24-hour)
- Discharge time(Duration of postoperative 24-hour)
- The time to first postoperative mobilisation(Duration of postoperative 24-hour)
- Numeric Rating Score (NRS)(Postoperative 1, 2, 4, 8, 12 and 24-hour.)
- Supplement analgesia requirement(Postoperative 1, 2, 4, 8, 12 and 24-hour.)
研究者
Demet Laflı Tunay
Assist Prof
Cukurova University