Quadroiliac Plane Block for Analgesia After Renal Transplantation
ID: NCT07716566
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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.
Read Full Scientific Objectives & Methods
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. Surgical Wound Infiltration Group Participants assigned to the active-comparator group will receive surgical wound infiltration after completion of surgical closure. A total of 10 mL of 0.25% bupivacaine will be administered along the surgical incision into the subcutaneous tissues using an evenly distributed infiltration technique. Standardized Postoperative Analgesia At the end of surgery, all participants will receive the following intravenous medications: Tramadol 100 mg Paracetamol 1 g Dexketoprofen 50 mg Postoperatively, intravenous paracetamol 1 g will be administered three times daily. Intravenous patient-controlled analgesia will be provided using tramadol at a concentration of 3 mg/mL. The device will be programmed to deliver a 20 mg patient-initiated bolus with a 15-minute lockout interval and without a background infusion. Outcome Assessments Postoperative pain intensity will be evaluated using an 11-point Numerical Rating Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be assessed both at rest and during movement at postoperative hours 0, 1, 6, 12, and 24. The primary outcome will be cumulative tramadol consumption recorded by the patient-controlled analgesia device during the first 24 postoperative hours. The sensory distribution of the quadroiliac plane block will be assessed at postoperative hour 2 using a cold sensation test with an ice cube. Relevant abdominal dermatomes will be evaluated, and areas with reduced or absent cold sensation will be recorded. Postoperative motor function will be evaluated at predefined assessment times. The presence of nausea, vomiting, and sedation will also be recorded during the first 24 postoperative hours. Quality of postoperative recovery will be evaluated using the Quality of Recovery-11 questionnaire at postoperative hour 24. The study aims to determine whether the ultrasound-guided quadroiliac plane block reduces postoperative tramadol consumption and improves analgesia and recovery compared with surgical wound infiltration in patients undergoing renal transplantation.
With the participant 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 needle will be advanced using an in-plane approach into 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 on the surgical side.
Following completion of surgical closure, a total of 10 mL of 0.25% bupivacaine will be infiltrated evenly into the subcutaneous tissues along the surgical incision. The infiltration will be performed using a standardized technique before the participant emerges from general anesthesia.
Treatment Arms Description
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.
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.
- 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
- 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
- Sepsis
- 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
Primary Outcome Measures
- Cumulative Tramadol Consumption During the First 24 Postoperative Hours — Time Frame: During the first 24 postoperative hours
The total amount of tramadol delivered by the patient-controlled analgesia device will be recorded in milligrams.
View Secondary Outcome Measures (5)
- Postoperative Pain Scores at Rest — Time Frame: At postoperative hours 0, 1, 6, 12, and 24
Pain at rest will be assessed using an 11-point Numerical Rating Scale ranging from 0, no pain, to 10, the worst imaginable pain.
- Postoperative Pain Scores During Movement — Time Frame: At postoperative hours 0, 1, 6, 12, and 24
Pain during movement will be assessed using an 11-point Numerical Rating Scale ranging from 0, no pain, to 10, the worst imaginable pain.
- Dermatomal Distribution Assessed by Cold Sensation — Time Frame: At postoperative hour 2
The abdominal dermatomes showing changed or absent cold sensation will be assessed using an ice-cube test.
- Incidence of Postoperative Nausea and Vomiting — Time Frame: During the first 24 postoperative hours
The number and proportion of participants experiencing nausea, vomiting, or both will be recorded.
- Quality of Recovery-11 Score — Time Frame: At postoperative hour 24
Postoperative recovery and patient satisfaction will be assessed using the Quality of Recovery-11 questionnaire. Higher scores indicate better postoperative recovery.
This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
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View Official Medical/Scientific Title
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