NCT07009782

Brief Summary

The goal of this clinical trial is to learn whether the Quadroiliac Plane (QIP) block helps reduce postoperative opioid use in adults undergoing femur fracture surgery. It will also evaluate the pain control effectiveness, dermatomal spread, and safety of the QIP block. The main questions it aims to answer are: Does the QIP block reduce total opioid (fentanyl) consumption within 24 hours after surgery? Does the QIP block reduce the need for rescue analgesia? What is the extent of dermatomal spread and are there any side effects or complications? Researchers will compare patients receiving the QIP block to those receiving standard care without a block to see if the QIP block improves pain management outcomes. Participants will: Undergo femur fracture surgery under spinal anesthesia Be randomly assigned to receive either the QIP block or no block after surgery Use a patient-controlled analgesia (PCA) device with fentanyl Have their pain scores, drug use, and recovery quality measured over 24 hours Undergo a cold test at 2 hours post-op and complete a recovery questionnaire at 24 hours

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 28, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

May 28, 2025

Last Update Submit

November 17, 2025

Conditions

Keywords

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Total Opioid Consumption Within the First 24 Hours Postoperatively

    The total amount of fentanyl (in micrograms) administered via intravenous patient-controlled analgesia (PCA) will be recorded during the first 24 hours after surgery. This will be used to assess the analgesic efficacy of the Quadroiliac Plane (QIP) block compared to standard care without a block.

    24 hours postoperatively

Secondary Outcomes (5)

  • Rescue Analgesia Requirement

    24 hours

  • Pain Scores at Rest and on Movement

    0,6,12 and 24 hours

  • Extent of Dermatomal Coverage Measured by Cold Sensation Response to Alcohol Swab at 2 Hours Post-QIP Block

    2 hours postoperatively

  • Postoperative Recovery Quality

    24 hours postoperatively

  • Block-Related Complications

    24 hours

Study Arms (2)

QIP Block Group

EXPERIMENTAL

Participants in this group will receive a Quadroiliac Plane (QIP) block using 40 mL of 0.25% bupivacaine under ultrasound guidance, applied postoperatively while in the prone position. The block will be performed only on the surgical side. All patients will also receive standard postoperative multimodal analgesia, including intravenous patient-controlled analgesia (PCA) with fentanyl.

Procedure: QIP block

Control Group

NO INTERVENTION

Participants in this group will not receive a regional block. They will be managed with standard postoperative multimodal analgesia, including intravenous patient-controlled analgesia (PCA) with fentanyl.

Interventions

QIP blockPROCEDURE

The Quadroiliac Plane (QIP) block is a novel ultrasound-guided fascial plane block. In this study, it will be performed postoperatively under spinal anesthesia in the prone position. A low-frequency convex transducer will be used to visualize the quadratus lumborum muscle at its attachment to the inner iliac crest. Using an in-plane technique with a 22G x 100 mm needle, 40 mL of 0.25% bupivacaine will be injected into the fascial plane beneath the quadratus lumborum muscle. The block will be performed unilaterally on the surgical side. The aim is to provide postoperative analgesia in patients undergoing femur fracture surgery.

QIP Block Group

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18 years and older
  • Scheduled for partial hip arthroplasty due to femur fracture
  • ASA physical status classification I to III
  • No contraindications to regional anesthesia or study medications
  • Capable of understanding and using patient-controlled analgesia (PCA)
  • Provided written informed consent

You may not qualify if:

  • ASA classification IV or higher
  • History of bleeding disorders or use of anticoagulant therapy
  • Known allergy to local anesthetics
  • Presence of neuropathic pain disorders
  • Undergoing emergency surgery
  • Unable to operate PCA device
  • Declined to participate or refused consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

Istanbul, Istanbul, 34303, Turkey (Türkiye)

Location

Related Publications (1)

  • Turan EI, Baydemir AE, Sahin AS. Efficacy of the quadro-iliac plane block in postoperative pain management for proximal femoral nail surgeries. Minerva Anestesiol. 2025 Mar;91(3):221-223. doi: 10.23736/S0375-9393.24.18506-9. Epub 2024 Nov 4. No abstract available.

    PMID: 39495169BACKGROUND

MeSH Terms

Conditions

Femoral FracturesPain, Postoperative

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg InjuriesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Engin ihsan Turan, Specialist

    Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Pain assessments, including Numerical Rating Scale (NRS) scores, cold test evaluations, and Quality of Recovery-15 (QOR-15) questionnaires, will be performed by outcome assessors who are blinded to the group allocation. These assessors will not be involved in the administration of the Quadroiliac Plane (QIP) block and will be unaware of whether the patient received the block or not. This ensures unbiased evaluation of analgesic outcomes.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
anesthesiology and reanimation specialist

Study Record Dates

First Submitted

May 28, 2025

First Posted

June 8, 2025

Study Start

June 1, 2025

Primary Completion

October 1, 2025

Study Completion

October 15, 2025

Last Updated

November 20, 2025

Record last verified: 2025-11

Locations