Quadroiliac Plane Block for Analgesia After Renal Transplantation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorKanuni Sultan Suleyman Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultrasound-Guided Quadroiliac Plane Block

    Procedure/Surgery

    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.

  • Surgical Wound Infiltration With Bupivacaine

    Procedure/Surgery

    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 groups

60 Participants
are divided into 2 treatment groups
Group A: Quadro-Iliac Plane Block GroupExperimental treatment 1 intervention
Group B: Surgical Wound Infiltration GroupActive comparator 1 intervention

Trial outcomes

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.

Time frame
During the first 24 postoperative hours

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.