Comparison of Pericapsular Nerve Group (PENG) Block With a Combined Femoral, Sciatic, Lateral Femoral Cutaneous Nerve Block for Postoperative Analgesia in Secondary Total Hip Arthroplasty.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Cumulative postoperative morphine consumption at day 1
研究概览
简要总结
The aim of this clinical trial is to compare the analgesic effect of a pericapsular nerve group (PENG) block with a combined femoral, sciatic, lateral femoral cutaneous nerve block for postoperative analgesia in patients scheduled for secondary total hip arthroplasty. The primary objective of this study is to compare postoperative pain management between the PENG block and the combined block (femoral, sciatic, lateral femoral cutaneous) by measuring postoperative morphine consumption in each of the two groups.
Participants will be randomized into two groups. Patients assigned to the PENG group will receive a PENG block with ropivacaine, followed by a sham (sciatic) block, and spinal anesthesia with isobaric bupivacaine. Patients assigned to the combined block group will receive femoral, sciatic, lateral femoral cutaneous nerve blocks with ropivacaine, followed by spinal anesthesia with isobaric bupivacaine.
详细描述
This is a single-center, prospective, superiority, randomized, double-blind, parallel-group study.
Patients will be randomized into two groups of 25 patients each, for a total enrollment plan of 50 patients. After written informed consent, patients will be allocated to one of the two groups according to a computer-generated randomization list.
The nerve blocks will be performed using ultrasound guidance.
During the surgery, 0.15 mg/kg of dexamethasone IV, 1 g paracetamol IV, 30 mg ketorolac IV, and 40 mg/kg magnesium IV will be given for postoperative analgesia.
In the PACU, pain management will be provided as needed with 2 mg of IV morphine at ten-minute intervals for pain scores >4. Once spinal motor block has resolved, the patients will be transferred to the surgical ward with a morphine patient-controlled analgesia (PCA) pump. The pump parameters will allow 2 mg boluses of morphine with a 10-minute lockout and a maximum dose of 40 mg in 4 hours.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients
- •ASA (American Society of Anaesthesiologists) I-III
- •18 years of age or older
- •Patients scheduled for elective secundary hip arthroplasty
- •Able to give written conformed consent autonomously
排除标准
- •Refusal or inability to give consent
- •Allergy to any of: ropivacaine, paracetamol, ibuprofen, ketorolac, morphine, ondansetron or dexamethasone
- •Bleeding diathesis
- •Neurological deficit of the operative side
- •Existing preoperative opioid use
- •Renal insufficiency (GFR<30ml/min according to the Cockroft-Gault formula)
- •Hepatic insufficiency
- •Morbid Obésity III
研究组 & 干预措施
PENG group
Pericapsular nerve group block
干预措施: Pericapsular nerve group (PENG) block with 0.75% ropivacaine guided by ultrasound (Drug)
Combined nerve block
Combined femoral, sciatic, lateral femoral cutaneous nerve block
干预措施: Femoral, sciatic and lateral femoral cutaneous nerve block with 0.375% ropivacaine (Drug)
结局指标
主要结局
Cumulative postoperative morphine consumption at day 1
时间窗: Time Frame: 24 hours postoperatively
Description: total consumption in mg
次要结局
- Morphine consumption in the recovery room(from admission till discharge from the recovery room, up to 2 hours)
- PCA administered morphine consumption at day 2(at day 2 postoperatively)
- Rest and dynamic pain scores(At 2 hours, day 1 and day 2 postoperatively)
- Incidence of postoperative nausea and vomiting(at 2 hours, day 1 and day 2 postoperatively)
- Incidence of pruritus(at 2 hours, day 1 and day 2 postoperatively)
- Incidence of urinary retention requiring bladder catheterisation(from surgery till day 2 postoperatively)
- Duration of analgesia(from the time the study procedure is performed up to 36 hours after surgery)
- Operated limb quadriceps strength(At day 1 and day 2 postoperatively)
- Walking test(At day 1 and 2 postoperatively)
研究者
Eric Albrecht
Prof. Dr. Med. Eric Albrecht, Associate Professor, University of Lausanne
Centre Hospitalier Universitaire Vaudois