- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07683663
QIPB vs SI-FICB for Postoperative Analgesia After Total Hip Arthroplasty
June 27, 2026 updated by: Onur KUCUK, Dokuz Eylul University
Comparison of Quadro-Iliac Plane Block and Supra-Inguinal Fascia Iliaca Compartment Block for Postoperative Analgesia in Total Hip Arthroplasty: A Prospective, Double-Blind, Non-Inferiority Study
Total hip arthroplasty (THA) causes moderate-to-severe postoperative pain.
The PROSPECT guideline recommends the supra-inguinal fascia iliaca compartment block (SI-FICB) for THA, whereas evidence for newer quadratus-lumborum-family blocks is limited.
The quadro-iliac plane block (QIPB) is a recently described fascial plane block, and no study has compared QIPB with SI-FICB head-to-head in any surgical context.
In this prospective, double-blind, patients undergoing elective THA who receive one of the two routinely used preoperative blocks (SI-FICB or QIPB, chosen by the attending anesthesiologist as part of routine care) are systematically observed and compared.
The primary objective is to assess whether the postoperative analgesic efficacy of QIPB is non-inferior to SI-FICB, using the resting NRS pain score at 6 hours postoperatively as the primary endpoint (non-inferiority margin Δ = 1.3).
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Onur Küçük, associate professor
- Phone Number: +90 5358543333
- Email: onur.kucuk@deu.edu.tr
Study Locations
-
-
Balçova
-
Izmir, Balçova, Turkey (Türkiye), 35340
- Dokuz Eylül University
-
Contact:
- Onur Küçük, associate professor
- Phone Number: +90 5358543333
- Email: onur.kucuk@deu.edu.tr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adults aged 18-75 years
- Scheduled for elective primary total hip arthroplasty
- ASA physical status I-III
- Able to understand and communicate in Turkish and complete assessment scales
- Completed preoperative anesthesia evaluation and approved for surgery
- Signed written informed consent
Exclusion Criteria:
- Known allergy/contraindication to any local anesthetic, including bupivacaine
- Coagulopathy or anticoagulant/antiplatelet therapy contraindicating block (per ASRA 2022)
- Active infection or skin breakdown at the block site
- Chronic opioid use (≥3 months daily) or history of opioid dependence
- Morbid obesity (BMI > 40 kg/m²)
- Cognitive impairment or communication difficulty precluding reliable NRS/QoR-15 assessment
- Pregnancy or breastfeeding
- Revision THA or emergency THA for fracture
- Intraoperative complications requiring major protocol deviation (e.g., >1000 mL blood loss, cardiac arrest)
- Technically failed block (no sensory change at any region on the T1 cold test)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: SI-FICB
Patients receiving supra-inguinal fascia iliaca compartment block (single-shot, US-guided, 40 mL 0.25% bupivacaine, preoperative).
|
SIFICB is an ultrasound-guided fascial plane block performed via a supra-inguinal approach to the iliac fascia compartment, targeting the femoral nerve, lateral femoral cutaneous nerve, and obturator nerve.
Single-shot, US-guided, 40 mL 0.25% bupivacaine, before GA induction.
|
|
Experimental: QIPB
Patients receiving quadro-iliac plane block (single-shot, US-guided, 40 mL 0.25% bupivacaine, preoperative).
|
QIPB is a facial plane block performed under ultrasound guidance with local anesthetic in the interfascial plane between the erector spinae and the quadratus lumborum muscle, at the distal attachment site of the quadratus lumborum muscle on the iliac crest.
Single-shot, US-guided, 40 mL 0.25% bupivacaine, before GA induction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity at rest at 6 hours postoperatively
Time Frame: 6 hours after surgery
|
Numeric Rating Scale (NRS), 0 = no pain to 10 = worst imaginable pain, measured at rest by a blinded assessor.
Non-inferiority margin Δ = 1.3 NRS points.
|
6 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
NRS pain at rest
Time Frame: 0, 2, 4, 6, 12, 24, 48 hours postoperatively
|
0, 2, 4, 6, 12, 24, 48 hours postoperatively
|
|
NRS pain on movement (active hip flexion)
Time Frame: 0, 2, 4, 6, 12, 24, 48 hours postoperatively
|
0, 2, 4, 6, 12, 24, 48 hours postoperatively
|
|
Cumulative opioid consumption
Time Frame: 24 hours and 48 hours
|
24 hours and 48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Onur Küçük, associate professor, Dokuz Eylül University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 30, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
June 1, 2027
Study Registration Dates
First Submitted
June 23, 2026
First Submitted That Met QC Criteria
June 27, 2026
First Posted (Actual)
July 6, 2026
Study Record Updates
Last Update Posted (Actual)
July 6, 2026
Last Update Submitted That Met QC Criteria
June 27, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026/11-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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