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

NCT07716540 | Recruiting

• 1 other identifier: Deep Iliac
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain Management

Outcome Measures

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.

  From completion of surgery to postoperative hour 24

Secondary Outcomes (8)

• Postoperative Numerical Rating Scale Pain Scores at Rest

  At postoperative hours 1, 6, 12, and 24

• Postoperative Numerical Rating Scale Pain Scores During Movement

  At postoperative hours 1, 6, 12, and 24

• Requirement for Rescue Analgesia During the First 24 Postoperative Hours

  During the first 24 postoperative hours

• Cumulative Dexketoprofen Consumption During the First 24 Postoperative Hours

  During the first 24 postoperative hours

• Dermatomal Distribution of Sensory Blockade Assessed by Cold Sensation

  At postoperative hour 2

Study Arms (2)

Deep Ilacus plane block group

ACTIVE COMPARATOR

Participants assigned to this group will receive an ultrasound-guided unilateral deep iliacus plane block on the surgical side after completion of hip fracture surgery. The block will be performed using 30 mL of 0.25% bupivacaine. All participants will also receive standardized spinal anesthesia and multimodal postoperative analgesia, including intravenous patient-controlled analgesia with tramadol.

Procedure: Ultrasound-Guided Deep Iliacus Plane Block With Bupivacaine

Sham Control Group

PLACEBO COMPARATOR

Participants assigned to this group will undergo an identical ultrasound-guided deep iliacus plane block procedure on the surgical side and will receive 30 mL of normal saline as a sham intervention. All participants will also receive standardized spinal anesthesia and the same multimodal postoperative analgesic regimen, including intravenous patient-controlled analgesia with tramadol.

Procedure: Sham Deep Iliacus Plane Block With Normal Saline

Interventions

Sham Deep Iliacus Plane Block With Normal Saline PROCEDURE

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.

Sham Control Group

Ultrasound-Guided Deep Iliacus Plane Block With Bupivacaine PROCEDURE

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.

Deep Ilacus plane block group

Eligibility Criteria

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

You may qualify if:

• 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
• No contraindication to spinal anesthesia or the deep iliacus plane block
• Written informed consent provided by the participant or legally authorized representative

You may not qualify if:

• 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
• Known allergy to local anesthetics or any study medication
• Pre-existing peripheral neuropathy, neurological disorder, or motor deficit involving the operated lower extremity
• Inability to understand or use the Numerical Rating Scale or patient-controlled analgesia device
• Cognitive impairment or communication difficulty preventing reliable postoperative assessment
• 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

Agnosia

Interventions

Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

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
• Masking Details: Participants and postoperative outcome assessors will be masked to group allocation. Both groups will undergo an identical ultrasound-guided deep iliacus plane block procedure. The anesthesiologist performing the block will be aware of the allocated intervention but will not participate in postoperative outcome assessment. Group allocation will remain concealed from participants and outcome assessors until completion of data collection, except when emergency unmasking is required for participant safety.
• 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): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

TU (1)