- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07546903
Comparison of Analgesic Efficacy of Suprainguinal Fascia Iliaca and Quadro-iliac Blocks in Hip Fracture Surgery
Comparison of the Postoperative Analgesic Efficacy of Ultrasound-Guided Suprainguinal Fascia Iliaca Block and Quadro-Iliac Plane Block in Patients Undergoing Hip Fracture Surgery
Hip fractures are common in the elderly and are associated with significant morbidity and mortality. Effective early analgesia is crucial for facilitating mobilization, reducing pulmonary complications, and improving overall outcomes. Although opioids are traditionally used for postoperative pain management, their adverse effects have led to increased interest in multimodal analgesia, particularly peripheral nerve blocks.
The suprainguinal fascia iliaca block (SIFI) is a modified technique that allows wider spread of local anesthetic, providing more effective blockade of the femoral, obturator, and lateral femoral cutaneous nerves. The quadro-iliac plane block (QIPB), a recently described interfascial block, is performed at the level of the anterior superior iliac spine and may also affect branches of the lumbar and sacral plexus.
While both techniques have been shown to provide effective analgesia and reduce opioid consumption, there is no study directly comparing them. Therefore, this study aims to compare the postoperative analgesic efficacy of SIFI and QIPB in patients undergoing hip fracture surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hip fractures are a significant health problem, particularly in the elderly, often resulting from osteoporosis, impaired balance, and falls, and leading to functional loss and increased dependency. The main subtypes include femoral neck, intertrochanteric, and subtrochanteric fractures. Surgical management typically involves internal fixation techniques such as proximal femoral nail (PFN), while complex fractures involving the acetabulum may require partial or total hip arthroplasty. Total hip arthroplasty is generally preferred in cases with acetabular involvement or advanced joint degeneration, whereas partial hip arthroplasty is commonly performed when the acetabulum is intact.
Adequate early postoperative analgesia is essential for both patient comfort and the prevention of complications. Insufficient pain control is associated with an increased risk of pulmonary complications, deep vein thrombosis, pressure ulcers, delayed mobilization, and even mortality. Opioid analgesics, widely used in postoperative pain management, are associated with significant side effects such as nausea, vomiting, constipation, sedation, and respiratory depression. Therefore, multimodal analgesia protocols have gained prominence, aiming to reduce opioid consumption and provide a safer and more comfortable postoperative period. Peripheral nerve blocks play a major role within these approaches.
Among anatomically suitable blocks for hip surgery are the suprainguinal fascia iliaca block (SIFI) and the quadro-iliac plane block (QIPB). SIFI is a proximal modification of the classical fascia iliaca block, targeting a wider spread to block the femoral, lateral femoral cutaneous, and obturator nerves. It is performed under ultrasound guidance by injecting local anesthetic into the potential space between the iliacus muscle and the fascia iliaca at the level of the anterior superior iliac spine (ASIS). Systematic reviews have shown that SIFI provides lower postoperative pain scores and significantly reduces opioid requirements, and is more effective than the classical technique in facilitating early mobilization.
QIPB, described by Tulgar et al. in 2024, is a novel anatomically based interfascial block. In this technique, after ultrasound imaging at the level of the posterior iliac crest using a convex probe, local anesthetic is injected into the potential plane between the iliacus muscle and the iliac wing. This region encompasses pathways of the femoral, obturator, lateral femoral cutaneous, genitofemoral, and ilioinguinal nerves, allowing for a broad क्षेत्र of neural coverage. Prospective observational studies by Marrone et al. and Turan et al. have demonstrated that QIPB provides effective early analgesia, reduces opioid consumption, and facilitates mobilization.
Although studies evaluating the analgesic efficacy of SIFI and QIPB exist, no randomized controlled trial directly comparing these two techniques has been identified. Additionally, methodological differences such as timing of block application, assessment points, and patient populations are present in the literature. In this study, the effects of SIFI and QIPB on postoperative 24-hour opioid consumption will be compared. Blocks will be performed preoperatively in the operating room under ultrasound guidance, and local anesthetic doses will be standardized for patient safety. The primary aim is to evaluate the analgesic efficacy of these two regional block techniques and to contribute to the existing gap in the literature.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: MUHAMMED ATICI
- Phone Number: +905535716152
- Email: dr.matc92@gmail.com
Study Locations
-
-
-
Çorum, Turkey (Türkiye), 19100
- Recruiting
- Hitit University
-
Contact:
- Guvenc Dogan, Proffesor
- Phone Number: +90 532 4025208
- Email: guvencdogan@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 18 years and older
- ASA physical status I-III
- Hemodynamically stable patients
- Scheduled for surgical treatment of hip fracture
- Body mass index (BMI) ≤ 35 kg/m²
- Provided written informed consent
Exclusion Criteria:
- Refusal to participate
- ASA physical status IV-V
- Hemodynamically unstable patients
- Surgery not completed as planned
- Infection at the block site
- History of allergy to local anesthetics or tramadol
- Presence of neuromuscular or peripheral nerve diseases
- Chronic pain conditions
- Coagulopathy or ongoing anticoagulant therapy
- High-dose opioid use within the last 3 days
- Severe hepatic or renal insufficiency
- Diabetes mellitus
- Pregnancy or breastfeeding
- NRS score >7 for four consecutive hours despite multimodal analgesia
- Inability to understand or use assessment tools (e.g., NRS, QoR-15)
- Inability to communicate in Turkish
- Inability to use PCA device due to technical reasons
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Suprainguinal Fascia Iliaca Block (Group S)
The patient will be positioned supine.
The application area will be sterilized with 10% povidone-iodine, and the linear ultrasound probe will be covered with a sterile sheath.
Using an in-plane technique with a 22-25G, 50-100 mm peripheral nerve block needle, the area between the iliacus muscle and the fascia iliaca will be reached at the level of the anterior superior iliac spine, proximal to the inguinal ligament.
Hydrodissection will be performed with 2 mL of saline, followed by the injection of 40 mL of 0.25% bupivacaine.
|
the area between the iliacus muscle and the fascia iliaca will be reached at the level of the anterior superior iliac spine, proximal to the inguinal ligament.
Hydrodissection will be performed with 2 mL of saline, followed by the injection of 40 mL of 0.25% bupivacaine.
|
|
Quadro-Iliac Plane Block (Group Q):
The patient will be positioned prone.
The application area will be sterilized with 10% povidone-iodine, and the linear ultrasound probe will be covered with a sterile sheath.
At the level of the L3 vertebra, the probe will be placed just lateral to the spinous process to visualize the erector spinae, quadratus lumborum, and psoas major muscles.
A 22-25G, 50-100 mm block needle will be advanced from cranially to caudal using the in-plane technique.
After administering 2 mL of saline for hydrodissection, 40 mL of 0.25% bupivacaine will be injected into the plana between the quadratus lumborum and the iliacus muscle.
Quadro-Iliac Plane Blocks are generally performed in the prone position.
However, depending on the patient's clinical condition or positional tolerance, the lateral decubitus position may be preferred.
In both positions, anatomical references and ultrasound imaging will be provided in a standard manner.
|
At the level of the L3 vertebra, the probe will be placed just lateral to the spinous process to visualize the erector spinae, quadratus lumborum, and psoas major muscles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Assessed by Numeric Rating Scale (NRS)
Time Frame: 24 hours postoperatively
|
Postoperative pain will be evaluated using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Higher scores indicate greater pain intensity.
|
24 hours postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ozgur Yagan, Proffesor, Hitit University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-161
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Post Operative Pain
-
Liaquat National Hospital & Medical CollegeCompletedPain | Post-operative Pain | Post-operative Pain ControlPakistan
-
Kaohsiung Medical University Chung-Ho Memorial...Not yet recruitingPostoperative Complications | Chronic Post Operative Pain | Acute Post Operative PainTaiwan
-
Unity Health TorontoAFP Innovation FundRecruitingSpinal Surgery | Post-operative Pain Management | Post-operative CareCanada
-
MercyOne Des Moines Medical CenterTerminatedPost Operative Pain | Post Operative Nausea and VomitingUnited States
-
Ain Shams UniversityRecruiting
-
University Tunis El ManarCompletedPost-operative Pain | Post-operative AnxietyTunisia
-
E-DA HospitalNot yet recruitingCesarean Section | Post Operative Pain, Acute | Post Operative Pain, ChronicTaiwan
-
Mount Sinai Hospital, CanadaWomen's College HospitalRecruitingSurgery | Laparoscopy | Post-operative Pain | Laparoscopic | Post-operative Recovery | PenumoperitoneumCanada
-
University of HaifaRecruiting
-
Sohag UniversityNot yet recruitingPost Operative Pain
Clinical Trials on Suprainguinal Fascia Iliaca Block
-
Sivas Numune HospitalRecruitingPostoperative Pain | Acute Postoperative Pain | Hip Arthroplasty | Regional AnesthesiaTurkey (Türkiye)
-
University College Hospital GalwayRecruitingTotal Hip Arthroplasty (THA)Ireland
-
Cumhuriyet UniversityNot yet recruiting
-
Ain Shams UniversityCompleted
-
Kocaeli City HospitalCompletedPain, Postoperative | Knee Arthroplasty, Total | Peripheral Nerve BlockTurkey
-
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training...RecruitingPostoperative Pain | Hip Fracture | Regional AnesthesiaTurkey (Türkiye)
-
SSM Health Bone and Joint Hospital at St AnthonyRecruitingAnalgesiaUnited States
-
Samsun UniversityCompletedAnesthesia | Regional Anesthesia | Anesthesia ManagementTurkey
-
Al-Azhar UniversityBenha UniversityCompletedHip Fractures | Spinal AnesthesiaEgypt
-
Udayana UniversityEnrolling by invitationPain, PostoperativeIndonesia