NCT07683663

Brief Summary

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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Jun 2026Jun 2027

First Submitted

Initial submission to the registry

June 23, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

June 30, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 6, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

July 6, 2026

Status Verified

June 1, 2026

Enrollment Period

5 months

First QC Date

June 23, 2026

Last Update Submit

June 27, 2026

Conditions

Keywords

regional anesthesiaquadro-iliac plane blockfascia iliaca blockopioid consumptionquality of recovery

Outcome Measures

Primary Outcomes (1)

  • Pain intensity at rest at 6 hours postoperatively

    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 Outcomes (3)

  • NRS pain at rest

    0, 2, 4, 6, 12, 24, 48 hours postoperatively

  • NRS pain on movement (active hip flexion)

    0, 2, 4, 6, 12, 24, 48 hours postoperatively

  • Cumulative opioid consumption

    24 hours and 48 hours

Study Arms (2)

SI-FICB

ACTIVE COMPARATOR

Patients receiving supra-inguinal fascia iliaca compartment block (single-shot, US-guided, 40 mL 0.25% bupivacaine, preoperative).

Procedure: Supra-Inguinal Fascia Iliaca Compartment Block

QIPB

EXPERIMENTAL

Patients receiving quadro-iliac plane block (single-shot, US-guided, 40 mL 0.25% bupivacaine, preoperative).

Procedure: Quadro-Iliac Plane Block

Interventions

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.

SI-FICB

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.

QIPB

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylül University

Izmir, Balçova, 35340, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, HipPain, PostoperativeAcute Pain

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Onur Küçük, associate professor

    Dokuz Eylul University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Onur Küçük, associate professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 23, 2026

First Posted

July 6, 2026

Study Start

June 30, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

July 6, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations