NCT07410000

Brief Summary

This prospective, randomized, double-blind study evaluates the analgesic effectiveness of the ultrasound-guided Quadro-Iliac Plane (QIP) block in patients undergoing primary total hip arthroplasty. The QIP block is a recently described fascial plane block. Patients will be randomized to receive either a QIP block with local anesthetic or a sham block with saline. The primary outcome is 24-hour opioid consumption. Secondary outcomes include motor block, dermatomal sensory assessment, pain scores, rescue analgesic requirement, quality of recovery (QoR-15), and opioid-related side effects.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Mar 2026Mar 2027

First Submitted

Initial submission to the registry

February 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 16, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2027

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2027

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

February 7, 2026

Last Update Submit

March 26, 2026

Conditions

Keywords

Total Hip ArthroplastyPostoperative AnalgesiaQuadro-Iliac Plane Block

Outcome Measures

Primary Outcomes (1)

  • Postoperative 24-Hour Morphine PCA Consumption

    Total amount of morphine delivered by the patient-controlled analgesia (PCA) device during the first 24 hours after surgery, recorded in milligrams (mg).

    Postoperative 24 hours

Secondary Outcomes (5)

  • NRS Pain Scores at Rest and Movement

    2, 6, 12, 24, and 48 hours postoperatively

  • QoR-15 Recovery Score

    QoR-15 Recovery Score will be evaluated at the postoperative 48th hour

  • Lower Extremity Muscle Strength Score

    Postoperative 6th and 12th hours

  • Rescue Analgesic Requirement

    Postoperative 0-48 hours

  • Opioid-Related Side Effects

    Postoperative 0-48 hours

Study Arms (2)

Quadro-Iliac Plane (QIP) Block

EXPERIMENTAL

Participants in this arm will receive the standard analgesia protocol used for patients undergoing total hip arthroplasty. In addition to this standard regimen, an ultrasound-guided Quadro-Iliac Plane (QIP) block will be performed in the preoperative period with the patient in the lateral decubitus position. The technique aims to provide postoperative analgesia by achieving sensory blockade in the relevant dermatomal areas.

Procedure: Quadro-Iliac Plane (QIP) Block

Sham Block (Control)

PLACEBO COMPARATOR

Participants in this arm will receive the standard analgesia protocol used for patients undergoing total hip arthroplasty. In addition to this standard regimen, a sham block will be performed using the same ultrasound-guided technique and patient positioning to mimic the block procedure without providing active regional anesthesia.

Procedure: Sham Block

Interventions

An ultrasound-guided Quadro-Iliac Plane block performed in the preoperative period. At the level of the iliac crest, 40 mL of a solution containing 0.25% levobupivacaine and 5 µg/mL epinephrine is injected into the fascial plane between the erector spinae muscle and the quadratus lumborum muscle under aseptic conditions.

Also known as: QIP Block
Quadro-Iliac Plane (QIP) Block
Sham BlockPROCEDURE

A sham block performed using the same ultrasound-guided technique in the preoperative period. At the level of the iliac crest, 40 mL of 0.9% NaCl is injected into the fascial plane between the erector spinae muscle and the quadratus lumborum muscle under aseptic conditions.

Also known as: Control Block
Sham Block (Control)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists (ASA) classification I-III
  • Age between 18 and 80 years
  • Patients scheduled for elective primary total hip arthroplasty

You may not qualify if:

  • Refusal to participate in the study
  • Allergy to local anesthetics or opioids
  • Known or suspected coagulopathy
  • Infection at the injection site
  • History of previous hip surgery
  • Severe cardiovascular disease
  • Liver or kidney failure
  • Pregnancy, suspected pregnancy, or breastfeeding
  • Severe neurological or psychiatric disorder
  • Chronic opioid use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa City Hospital

Bursa, 16110, Turkey (Türkiye)

RECRUITING

Related Publications (5)

  • Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.

    PMID: 29026331BACKGROUND
  • Carella M, Beck F, Piette N, Denys S, Kurth W, Lecoq JP, Bonhomme VL. Effect of suprainguinal fascia iliaca compartment block on postoperative opioid consumption and functional recovery in posterolateral-approached total hip arthroplasty: a single-blind randomized controlled trial. Reg Anesth Pain Med. 2022 Jun 15:rapm-2021-103427. doi: 10.1136/rapm-2021-103427. Online ahead of print.

    PMID: 35705263BACKGROUND
  • Marrone F, Sorrentino T, Pullano C, Tulgar S. A novel and feasible option for perioperative analgesia in hip fractures surgery: quadro-iliac plane block. Minerva Anestesiol. 2025 Jun;91(6):592-595. doi: 10.23736/S0375-9393.25.18801-9. Epub 2025 Mar 27. No abstract available.

    PMID: 40145906BACKGROUND
  • Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Girit M, Akin T, Narayanan M, Alici HA. Ultrasound guided quadro-iliac plane block: another novel fascial plane block. Pain Med. 2024 May 3;25(6):370-373. doi: 10.1093/pm/pnae018.

    PMID: 38459608BACKGROUND
  • Selvi O, Azizoglu M, Temel G, Tulgar S, Chitneni A, Cinar EN, Ozer Z, Gurkan Y. Translation and Validation of the Turkish Version of the Quality of Postoperative Recovery Score QoR-15: A Multi-Centred Cohort Study. Turk J Anaesthesiol Reanim. 2022 Dec;50(6):443-448. doi: 10.5152/TJAR.2022.21417.

    PMID: 36511494BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Central Study Contacts

Mursel Ekinci, Assoc prof,MD

CONTACT

Mustafa Dikici, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The study solutions will be prepared by an anesthesiologist who is not involved in patient care or data collection. The anesthesiologist performing the block and the patient will be blinded to group allocation. Postoperative assessments will be performed by an independent anesthesiologist who is also blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

February 7, 2026

First Posted

February 13, 2026

Study Start

March 16, 2026

Primary Completion (Estimated)

February 15, 2027

Study Completion (Estimated)

March 15, 2027

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations