Quadroiliac Plane Block for Analgesia After Renal Transplantation

NCT07716566 | Recruiting

• 1 other identifier: QIPB Transplanation
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Cumulative 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.

  During the first 24 postoperative hours

Secondary Outcomes (5)

• 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

• Dermatomal Distribution Assessed by Cold Sensation

  At postoperative hour 2

• Incidence of Postoperative Nausea and Vomiting

  During the first 24 postoperative hours

• Quality of Recovery-11 Score

  At postoperative hour 24

Study Arms (2)

Quadro-Iliac Plane Block Group

EXPERIMENTAL

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.

Procedure: Ultrasound-Guided Quadroiliac Plane Block

Surgical Wound Infiltration Group

ACTIVE COMPARATOR

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.

Procedure: Surgical Wound Infiltration With Bupivacaine

Interventions

Ultrasound-Guided Quadroiliac Plane Block PROCEDURE

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.

Quadro-Iliac Plane Block Group

Surgical Wound Infiltration With Bupivacaine PROCEDURE

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.

Surgical Wound Infiltration Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

Istanbul, Istanbul, 34303, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Engin ihsan Turan, principal investigator

CONTACT

+905382431114; enginihsan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): July 20, 2027
• Study Completion (Estimated): July 21, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

TU (1)