Analgesic Efficacy of Ultrasound-Guided Quadroiliac Plane Block Versus Surgical Wound Infiltration in Patients Undergoing Renal Transplantation: A Prospective, Randomized, Double-Blind, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Cumulative Tramadol Consumption During the First 24 Postoperative Hours
研究概览
简要总结
Renal transplantation is a major abdominal surgical procedure that may cause moderate to severe postoperative pain. Opioids are commonly used as part of multimodal analgesia; however, opioid-related adverse effects such as sedation, respiratory depression, nausea, vomiting, and constipation may delay recovery and mobilization.
The quadroiliac plane block is an ultrasound-guided interfascial plane block performed near the attachment of the quadratus lumborum muscle to the iliac crest. The technique may provide analgesia over a broad lower abdominal area and may reduce postoperative opioid requirements.
This prospective, randomized, double-blind, controlled clinical trial will compare an ultrasound-guided unilateral quadroiliac plane block with surgical wound infiltration in adult patients undergoing renal transplantation. Participants will be randomly assigned to receive either a quadroiliac plane block with 40 mL of 0.25% bupivacaine or surgical wound infiltration with 10 mL of 0.25% bupivacaine.
All participants will receive standardized multimodal analgesia and intravenous patient-controlled analgesia with tramadol. The primary objective is to compare cumulative tramadol consumption during the first 24 hours after surgery. Postoperative pain scores, dermatomal sensory distribution, motor block, nausea, vomiting, sedation, and quality of recovery will also be evaluated.
详细描述
This study is designed as a prospective, randomized, double-blind, parallel-group, controlled clinical trial involving adult patients undergoing renal transplantation.
Eligible participants will be randomly assigned in a 1:1 ratio to either the quadroiliac plane block group or the surgical wound infiltration group. A computer-generated block-randomization sequence will be used. Treatment assignments will be concealed in sequentially prepared, sealed envelopes and managed by a study team member who is not involved in postoperative outcome assessment.
Participants and postoperative outcome assessors will be masked to group allocation. The anesthesiologist performing the assigned intervention will be aware of the allocation but will not participate in postoperative data collection. The intervention will be performed while the participant remains anesthetized.
Quadroiliac Plane Block Group Participants assigned to the experimental group will receive an ultrasound-guided unilateral quadroiliac plane block on the surgical side. The participant will be placed in the lateral decubitus position. A low-frequency curvilinear ultrasound transducer will be positioned immediately above the posterior superior iliac spine and oriented parallel to the vertebral column.
The quadratus lumborum muscle, its attachment to the iliac crest, and the erector spinae muscle will be identified. A 22-gauge, 80-mm echogenic block needle will be advanced using an in-plane approach toward the fascial plane between the quadratus lumborum and erector spinae muscles. After confirmation of the target plane by hydrodissection and negative aspiration, 40 mL of 0.25% bupivacaine will be administered.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years
- •American Society of Anesthesiologists physical status I-III
- •Scheduled to undergo renal transplantation surgery
- •Ability to understand the study procedures and postoperative assessments
- •Provision of written informed consent
排除标准
- •Known allergy to bupivacaine or other amide-type local anesthetics
- •Infection at the planned injection site
- •Coagulopathy or anticoagulant therapy associated with an unacceptable bleeding risk for regional anesthesia
- •Severe spinal deformity or anatomical abnormality preventing performance of the quadroiliac plane block
- •Inability to cooperate or communicate reliably
- •Cognitive impairment or intellectual disability preventing informed consent or reliable outcome assessment
- •Altered level of consciousness
- •Breastfeeding
- •Refusal to participate
研究组 & 干预措施
Quadro-Iliac Plane Block Group
Participants assigned to this group will receive an ultrasound-guided unilateral quadroiliac plane block on the surgical side while under general anesthesia. The block will be performed using 40 mL of 0.25% bupivacaine. All participants will receive the same standardized multimodal analgesic regimen and postoperative intravenous patient-controlled analgesia with tramadol.
干预措施: Ultrasound-Guided Quadroiliac Plane Block (Procedure)
Surgical Wound Infiltration Group
Participants assigned to this group will receive surgical wound infiltration at the end of surgery. A total of 10 mL of 0.25% bupivacaine will be infiltrated into the subcutaneous tissues along the surgical incision. All participants will receive the same standardized multimodal analgesic regimen and postoperative intravenous patient-controlled analgesia with tramadol.
干预措施: Surgical Wound Infiltration With Bupivacaine (Procedure)
结局指标
主要结局
Cumulative Tramadol Consumption During the First 24 Postoperative Hours
时间窗: During the first 24 postoperative hours
The total amount of tramadol delivered by the patient-controlled analgesia device will be recorded in milligrams.
次要结局
- Postoperative Pain Scores at Rest(At postoperative hours 0, 1, 6, 12, and 24)
- Postoperative Pain Scores During Movement(At postoperative hours 0, 1, 6, 12, and 24)
- Incidence of Postoperative Nausea and Vomiting(During the first 24 postoperative hours)
- Quality of Recovery-11 Score(At postoperative hour 24)
- Dermatomal Distribution Assessed by Cold Sensation(At postoperative hour 2)
研究者
Engin Ihsan Turan
principal investigator
Kanuni Sultan Suleyman Training and Research Hospital