Evaluation of the Postoperative Analgesic Efficacy of the Quadroiliac Plane (QIP) Block in Femur Fracture Surgery

NCT ID: NCT07009782

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2025-10-15

Brief Summary

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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

Detailed Description

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This is a prospective, randomized, controlled, single-center clinical trial designed to evaluate the postoperative analgesic efficacy of the Quadroiliac Plane (QIP) block in patients undergoing femur fracture surgery, specifically partial hip arthroplasty under spinal anesthesia. The primary objective of the study is to assess the impact of the QIP block on total opioid consumption (fentanyl via PCA) during the first 24 hours postoperatively. Secondary objectives include evaluation of rescue analgesia needs, dermatomal spread of the block, incidence of motor block or complications, block feasibility and application time, patient satisfaction, and length of hospital stay.

Eligible participants aged 18 years or older who are scheduled for elective partial hip arthroplasty due to femoral neck fracture and meet inclusion criteria will be invited to participate. After obtaining written informed consent, patients will be randomly assigned to one of two groups using a computer-generated sequence and sealed envelope method. The intervention group will receive a QIP block postoperatively using 40 mL of 0.25% bupivacaine under ultrasound guidance. The control group will receive no regional block. Both groups will receive standard postoperative multimodal analgesia, including intravenous patient-controlled analgesia (PCA) with fentanyl.

Pain will be assessed using the Numerical Rating Scale (NRS), which ranges from 0 (no pain) to 10 (worst imaginable pain), at rest and with movement at 0, 6, 12, and 24 hours postoperatively. Rescue analgesia (50 mg dexketoprofen IV over 20 minutes) will be administered if needed. The dermatomal spread of the block will be evaluated using an alcohol-based cold test at 2 hours postoperatively. At 24 hours, all patients will complete the Quality of Recovery-15 (QOR-15) questionnaire, which scores recovery from 0 (poor recovery) to 150 (excellent recovery).

Conditions

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Femur Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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QIP Block Group

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.

Group Type EXPERIMENTAL

QIP block

Intervention Type PROCEDURE

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.

Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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QIP block

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Engin Ihsan Turan

anesthesiology and reanimation specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Engin ihsan Turan, Specialist

Role: PRINCIPAL_INVESTIGATOR

Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

Locations

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Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

Istanbul, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 39495169 (View on PubMed)

Other Identifiers

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QIPB in femur fractures

Identifier Type: -

Identifier Source: org_study_id

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