Ultrasound-guided Rectus Abdominis Muscle Sheath Block in Outpatient Umbilical Hernioplasties: a Comparative Analysis of the Use of Clonidine as an Adjuvant - Prospective Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Total opioid postoperative consumption
研究概览
简要总结
This clinical trial aims to evaluate the effectiveness of an ultrasound-guided nerve block technique as the sole anesthetic method for patients undergoing outpatient umbilical hernia surgery. The procedure, called rectus sheath block (RSB), involves injecting local anesthetic near the abdominal muscles to reduce pain during and after surgery. The study will compare two groups of adult patients: one receiving the nerve block with a medication called clonidine added to the anesthetic solution, and the other receiving the same block without clonidine. Clonidine may help improve pain control and reduce the need for additional pain medications. By analyzing pain scores, recovery quality, and potential side effects, the study seeks to determine whether the use of clonidine in this context is safe, cost-effective, and beneficial for patient recovery. Participants will answer questionnaires about their pain and recovery during the first 48 hours after surgery.
详细描述
This is a prospective, randomized, double-blind, controlled clinical trial designed to evaluate the effectiveness and safety of adding clonidine to a local anesthetic solution for ultrasound-guided rectus sheath block (RSB) in adult patients undergoing ambulatory umbilical hernioplasty. The study will be conducted at the Ambulatory Surgery Unit of the Policlínica Universitária Piquet Carneiro, part of the Universidade do Estado do Rio de Janeiro (UERJ), between January 2025 and April 2026.
Eligible patients (ASA I or II, aged 18-65) scheduled for elective outpatient umbilical hernia repair with a hernial defect ≤ 4 cm will be randomized into two groups. The intervention group (BRA-CLO) will receive bilateral RSB with a solution containing 8 mL of lidocaine 2%, 8 mL of ropivacaine 1%, and clonidine 75 mcg, diluted in 0.9% saline to a total volume of 20 mL, administered on each side. The control group (BRA) will receive an identical volume and concentration of local anesthetic without the addition of clonidine.
RSB will be performed under real-time ultrasound guidance (Butterfly iQ+ probe) using an in-plane technique with a Quincke 22G needle. Sedation with midazolam, fentanyl, and propofol will be administered as required. The block will be performed preoperatively under standard monitoring, including ECG, pulse oximetry, and non-invasive blood pressure.
The primary hypothesis is that the addition of clonidine will enhance the quality of intraoperative and postoperative analgesia, reduce opioid consumption, and improve overall postoperative recovery without increasing the risk of adverse events. To assess recovery quality, the validated Quality of Recovery-15 (QoR-15) questionnaire will be administered at postoperative 24 and 48 hours. Pain will be assessed using the Numeric Rating Scale (NRS) at predefined intervals (PACU, 24h and 48h). Sedation will be measured with the Richmond Agitation-Sedation Scale (RASS), and adverse events such as bradycardia, nausea, vomiting, conversion to general anesthesia, and postoperative complications will be recorded.
Randomization will be performed using block randomization with variable block sizes (4, 6, or 8) generated in R (v4.4.1), and allocation concealment will be ensured with sealed opaque envelopes. Data will be collected and managed using the REDCap platform, ensuring confidentiality and integrity.
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, Investigator)
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
- •Adults aged 18 to 65 years;
- •Both male and female participants;
- •ASA physical status I or II (American Society of Anesthesiologists classification);
- •Scheduled for elective ambulatory umbilical hernia repair;
- •Hernial defect size ≤ 4 cm (small to medium).
排除标准
- •Refusal or inability to provide written informed consent;
- •Cognitive or psychiatric disorders that impair comprehension or adherence to the study protocol;
- •Known allergy or hypersensitivity to local anesthetics, clonidine, opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), or other analgesics;
- •Participation in another clinical trial within the previous 30 days;
- •Missing data or loss to follow-up during postoperative assessments;
- •Contraindications to regional anesthesia or known coagulopathy.
研究组 & 干预措施
Rectus Sheath Block
Participants in this arm will receive bilateral ultrasound-guided rectus sheath block (RSB) without the addition of clonidine.
干预措施: Rectus Sheath Block (Drug)
Rectus sheath block with clonidine
Participants in this arm will receive bilateral ultrasound-guided rectus sheath block (RSB) with clonidine
干预措施: Rectus Sheath Block with Clonidine (Drug)
结局指标
主要结局
Total opioid postoperative consumption
时间窗: 48 hours postoperative
Total amount of opioid analgesics (in milligrams of tramadol equivalents) administered from the end of the surgical procedure to 48 hours postoperatively.
Postoperative pain intensity assessed by Numeric Rating Scale (NRS)
时间窗: At post-anesthesia care unit (PACU) admission (immediately after surgery), 24 hours after surgery, and 48 hours after surgery.
Pain scores reported by the patient using the 11-point Numeric Rating Scale (0 = no pain; 10 = worst imaginable pain) at each time point.
Total intraoperative opioid consumption
时间窗: From induction of anesthesia to the end of surgery.
Total intraoperative fentanyl consumption
次要结局
- Quality of recovery assessed by QoR-15 questionnaire(At post-anesthesia care unit (PACU) admission (immediately after surgery), 24 hours after surgery, and 48 hours after surgery.)
- Incidence of postoperative nausea and vomiting (PONV)(48 hours postoperatively)
研究者
Samuel Navarro Abreu
MD
Universidade Federal do Rio de Janeiro