Measuring the Analgesic Effect of Adding Pre-Operative Single Shot Rectus Sheath Blocks to Post-Operative Rectus Sheath Continuous Blocks for Major Urologic Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Opioid requirement in first 24 hours after surgery
研究概览
简要总结
Objectives The primary objective is to demonstrate that in patients undergoing major urologic surgery, Patient Controlled Analgesia (PCA) opioid consumption in the first 24 hours after surgery will be significantly less in patients who have had a single shot rectus sheath block pre-operatively in addition to a post-operative rectus sheath continuous block via surgically placed catheter versus those who only have post-operative rectus sheath continuous block. Secondary outcomes will be opioid requirement intra-operatively, Numerical Rating Scale (NRS) pain scores including maximum pain score in Post Anesthesia Care Unit (PACU) and score at 24 and 48 hours, incidence and severity of nausea, number of vomiting episodes, sedation score, time to first bowel movement, time to first mobilization and duration of hospital stay.
详细描述
Purpose: To improve analgesia and reduce opioid consumption in patients undergoing major urologic surgery.
Hypothesis: Patients receiving pre-operative single shot rectus sheath blockade in addition to continuous rectus sheath catheters will use less PCA opioid in the first 24 hours post-operatively compared to patients receiving continuous rectus sheath blockade for major urologic surgery.
Justification:
The sensorimotor innervation of the anterior abdominal wall is supplied by the ventral rami of the thoracolumbar spinal (T7-L1) segmental nerves. The thoracolumbar nerves course along the anterolateral wall within the transversus abdominis plane (TAP), and continue anteromedially, before entering the lateral aspect of the posterior rectus sheath. The nerves provide both muscular and cutaneous branches to innervate the muscle fibers and overlying skin with innervation from both left and right nerves supplying the midline. Regional anesthesia techniques for the anterior abdominal wall include both TAP and rectus sheath blocks.
The TAP block has been investigated extensively and shown to reduce opioid analgesia requirements post-operatively. The main difference between TAP block and rectus sheath block is that the rectus sheath block targets the nerves at a more anterior location. Bilateral rectus sheath nerve blocks are required to provide cover for midline incision and the investigators have previously described rectus sheath block with nerve catheter insertion under ultrasound guidance for midline laparotomy. A recent retrospective review from Dutton et al on the use of rectus sheath catheters for major urologic surgery reported that they offer an effective and safe method of peri-operative analgesia in patients undergoing major open urological pelvic surgery. Tudor et al demonstrated that rectus sheath catheters provide analgesia equivalent to that provided by epidurals following laparotomy for colorectal 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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The intra-operative anesthesiologist, surgeon and outcomes assessor are blinded to group allocation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients over 18 years
- •Undergoing major urological surgery
- •Consent to a rectus sheath blockade as part of their postoperative management
排除标准
- •Patients under 18 years
- •Local or systemic infection
- •Patients who refuse consent
- •Opioid tolerance
- •History of chronic pain
- •Psychiatric illness
- •Allergy to local anesthetic.
研究组 & 干预措施
Single shot rectus sheath block
The treatment group will have pre-operative ultrasound-guided single shot bilateral rectus sheath blocks with 20 ml of a ropivacaine / bupivacaine mixture per side.
干预措施: Rectus sheath block (Procedure)
Single shot rectus sheath block
The treatment group will have pre-operative ultrasound-guided single shot bilateral rectus sheath blocks with 20 ml of a ropivacaine / bupivacaine mixture per side.
干预措施: Bilateral rectus sheath catheter (Procedure)
Single shot rectus sheath block
The treatment group will have pre-operative ultrasound-guided single shot bilateral rectus sheath blocks with 20 ml of a ropivacaine / bupivacaine mixture per side.
干预措施: Patient controlled opioid analgesia (PCA) (Drug)
Placebo Control
The control group will have a pre-operative sham ultrasound-guided subcutaneous injection of 1ml saline per side.
干预措施: Bilateral rectus sheath catheter (Procedure)
Placebo Control
The control group will have a pre-operative sham ultrasound-guided subcutaneous injection of 1ml saline per side.
干预措施: Patient controlled opioid analgesia (PCA) (Drug)
Placebo Control
The control group will have a pre-operative sham ultrasound-guided subcutaneous injection of 1ml saline per side.
干预措施: Subcutaneous injection saline placebo (Procedure)
结局指标
主要结局
Opioid requirement in first 24 hours after surgery
时间窗: 24 hours
Opioid requirement in first 24 hours after surgery
次要结局
- (Numerical Rating Scale) NRS pain score at 24 and 48 hours(48 hours)
- Sedation score(48 hours)
- Time to first mobilization(48 hours)
- Intra-operative opioid requirement(3 - 6 hours)
- Severity of Nausea(48 hours)
- Use of anti-emetics(48 hours)
- Number of vomiting episodes(48 hours)
- Time to first bowel movement(Up to 7 days)
- Duration of hospital stay(7 - 14 days)