NCT06604806

Brief Summary

This prospective, multicenter study will compare the postoperative analgesic efficacy of the Quadroiliac Plane Block (QIPB) and Pericapsular Nerve Group (PENG) block in patients undergoing femoral neck fracture surgery. Eligible patients will be randomly assigned to receive one of the blocks postoperatively under spinal anesthesia. The blocks will be administered by experienced anesthesiologists, and informed consent will be obtained from all participants. Pain levels will be assessed using the visual analog scale (VAS) at rest and during movement at 0, 6, 12, and 24 hours post-surgery. Opioid consumption will be recorded through patient-controlled analgesia (PCA), and any need for rescue analgesia will be evaluated. Routine postoperative pain management will also include intravenous paracetamol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

11 months

First QC Date

September 17, 2024

Last Update Submit

November 17, 2025

Conditions

Keywords

postoperative pain managementfascial plan blockspainanalgesia

Outcome Measures

Primary Outcomes (1)

  • opioid consumption

    Opioid consumption in 24 hours will compared between these two block

    1 day

Secondary Outcomes (1)

  • Visual Analogue Scale

    1 day

Study Arms (2)

opioid consumption

ACTIVE COMPARATOR

opioid consumption of the patients in patient controlled analgesia device

Procedure: PENG BlockProcedure: Quadro-Iliac plane block

Visual Analogue Scale scores of the patients

ACTIVE COMPARATOR

Visual Analogue Scale scores of the patients

Procedure: PENG BlockProcedure: Quadro-Iliac plane block

Interventions

PENG BlockPROCEDURE

With the patient in the supine position, the ultrasound probe is placed transversely over the anterior superior iliac spine (ASIS). After identifying the ASIS, the transducer is aligned with the pubic ramus and rotated approximately 45 degrees to become parallel to the inguinal crease. The transducer is moved medially until the anterior inferior iliac spine (AIIS), iliopubic eminence (IPE), and psoas tendon are clearly visualized as anatomical landmarks. After confirming the correct location with saline injection, 50 mg of 0.25% bupivacaine will be administered.

Visual Analogue Scale scores of the patientsopioid consumption

With the patient in the prone position, a low-frequency convex transducer (2-6 MHz) and a 22G x 100 mm peripheral nerve block needle (Stimuplex® Ultra 360®, B-Braun) will be used. The transducer will be placed transversely at the L3 level to identify the spinal processes, followed by lateral movement to visualize the transverse process within the erector spinae muscle. The transducer will then be rotated parasagittally and moved caudally to locate where the Quadratus Lumborum muscle (QLM) attaches to the iliac crest. After confirming the location with saline, 50 mg of 0.25% bupivacaine will be administered under the fascia of the QLM.

Visual Analogue Scale scores of the patientsopioid consumption

Eligibility Criteria

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

You may qualify if:

  • Patients and their relatives have provided informed consent,
  • Patients aged 18 years or older undergoing femoral fracture surgery,
  • ASA score of I-III,
  • No history of bleeding diathesis,
  • No history of anticoagulant use that contraindicates block application according to guidelines,
  • No history of neuropathic diseases such as Diabetes Mellitus,
  • No known allergy to local anesthetics.

You may not qualify if:

  • Lack of informed consent from the patient or their relatives,
  • Development of complications during the surgical procedure,
  • Need for revision surgery,
  • Patient\'s desire to withdraw from the study,
  • Patients under the age of 18,
  • ASA score of IV or higher,
  • Patients with a history of bleeding diathesis,
  • History of anticoagulant use that contraindicates block application according to guidelines,
  • Emergency surgeries,
  • History of allergy to local anesthetics,
  • History of neuropathic diseases,
  • Inability to comply with patient-controlled analgesia (PCA) systems.

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

MeSH Terms

Conditions

Femoral FracturesPainAgnosia

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

September 17, 2024

First Posted

September 20, 2024

Study Start

October 1, 2024

Primary Completion

September 1, 2025

Study Completion

September 15, 2025

Last Updated

November 18, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations