Analgesic Efficacy of Ultrasound-Guided Deep Iliacus Plane Block in Patients Undergoing Hip Fracture Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKanuni Sultan Suleyman Training and Research Hospital

About this trial

Hip fracture surgery is commonly associated with moderate to severe postoperative pain, which may delay mobilization and increase the need for opioid analgesics. The deep iliacus plane block is a recently described ultrasound-guided regional anesthesia technique designed to provide analgesia by allowing local anesthetic spread toward the femoral nerve, lateral femoral cutaneous nerve, and articular branches supplying the hip.

This prospective, randomized, double-blind, sham-controlled clinical trial will evaluate the analgesic efficacy of the deep iliacus plane block in adult patients undergoing hip fracture surgery under spinal anesthesia. After surgery, participants will be randomly assigned to receive either an ultrasound-guided deep iliacus plane block with local anesthetic or a sham block with normal saline.

All participants will receive standardized multimodal postoperative analgesia, including patient-controlled analgesia. The primary objective is to determine whether the deep iliacus plane block reduces postoperative opioid consumption during the first 24 hours after surgery. Postoperative pain scores, rescue analgesic requirements, sensory distribution, motor block, nausea and vomiting, quality of recovery, patient satisfaction, and block-related complications will also be evaluated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

Scheduled to undergo unilateral hip fracture surgery under spinal anesthesia

American Society of Anesthesiologists (ASA) physical status I-III

Ability to understand and use the Numerical Rating Scale and patient-controlled analgesia device

Disqualifiers

ASA physical status IV or higher

Emergency surgery

Coagulopathy, bleeding diathesis, or anticoagulant treatment that contraindicates spinal anesthesia or peripheral nerve block

Infection at the planned needle insertion site

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultrasound-Guided Deep Iliacus Plane Block With Bupivacaine

    Procedure/Surgery

    Following completion of surgery, participants will receive an ultrasound-guided unilateral deep iliacus plane block on the surgical side. A low-frequency curvilinear ultrasound transducer will be used to identify the anterior inferior iliac spine, iliopsoas muscle, psoas tendon, femoral nerve, and adjacent vascular structures. A 22-gauge, 100-mm block needle will be advanced using an in-plane approach into the target plane between the iliopsoas muscle and the anterior inferior iliac spine. After confirmation of the appropriate needle-tip position, 30 mL of 0.25% bupivacaine will be administered.

  • Sham Deep Iliacus Plane Block With Normal Saline

    Procedure/Surgery

    Participants will undergo an identical ultrasound-guided unilateral deep iliacus plane block procedure on the surgical side. The same anatomical landmarks, ultrasound approach, needle type, and target plane will be used. After confirmation of the appropriate needle-tip position, 30 mL of normal saline will be administered as the sham intervention.

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Deep Ilacus plane block groupActive comparator 1 intervention
Group B: Sham Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative Tramadol Consumption During the First 24 Postoperative Hours

The total amount of tramadol, expressed in milligrams, delivered by the intravenous patient-controlled analgesia device during the first 24 hours after surgery will be recorded. The patient-controlled analgesia solution will contain tramadol at a concentration of 4 mg/mL, with a 20 mg bolus dose, a 20-minute lockout interval, no background infusion, and a maximum limit of 200 mg over four hours. Lower cumulative consumption indicates a lower postoperative opioid requirement.

Time frame
From completion of surgery to postoperative hour 24

Secondary outcomes

1

Postoperative Numerical Rating Scale Pain Scores at Rest

Postoperative pain intensity at rest will be assessed using an 11-point Numerical Rating Scale ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Scores will be recorded separately at each predefined postoperative assessment time.

Time frame
At postoperative hours 1, 6, 12, and 24
2

Postoperative Numerical Rating Scale Pain Scores During Movement

Postoperative pain intensity during movement will be assessed using an 11-point Numerical Rating Scale ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Scores will be recorded separately at each predefined postoperative assessment time.

Time frame
At postoperative hours 1, 6, 12, and 24
3

Requirement for Rescue Analgesia During the First 24 Postoperative Hours

The number and proportion of participants requiring at least one dose of rescue analgesia during the first 24 hours after surgery will be recorded. Intravenous dexketoprofen 50 mg will be administered as rescue analgesia when required despite the standardized multimodal analgesic regimen.

Time frame
During the first 24 postoperative hours
4

Cumulative Dexketoprofen Consumption During the First 24 Postoperative Hours

The total amount of intravenous dexketoprofen administered as rescue analgesia during the first 24 hours after surgery will be recorded in milligrams. Each rescue dose will consist of 50 mg of intravenous dexketoprofen.

Time frame
During the first 24 postoperative hours

Other outcomes

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