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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
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.
Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
Istanbul, Istanbul, Turkey (Türkiye)
RECRUITINGCumulative Tramadol Consumption During the First 24 Postoperative Hours
The total amount of tramadol delivered by the patient-controlled analgesia device will be recorded in milligrams.
Time frame: During the first 24 postoperative hours
Postoperative Pain Scores at Rest
Pain at rest will be assessed using an 11-point Numerical Rating Scale ranging from 0, no pain, to 10, the worst imaginable pain.
Time frame: At postoperative hours 0, 1, 6, 12, and 24
Postoperative Pain Scores During Movement
Pain during movement will be assessed using an 11-point Numerical Rating Scale ranging from 0, no pain, to 10, the worst imaginable pain.
Time frame: At postoperative hours 0, 1, 6, 12, and 24
Dermatomal Distribution Assessed by Cold Sensation
The abdominal dermatomes showing changed or absent cold sensation will be assessed using an ice-cube test.
Time frame: At postoperative hour 2
Incidence of Postoperative Nausea and Vomiting
The number and proportion of participants experiencing nausea, vomiting, or both will be recorded.
Time frame: During the first 24 postoperative hours
Quality of Recovery-11 Score
Postoperative recovery and patient satisfaction will be assessed using the Quality of Recovery-11 questionnaire. Higher scores indicate better postoperative recovery.
Time frame: At postoperative hour 24
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