Evaluation of the Postoperative Analgesic Efficacy of the Quadroiliac Plane (QIP) Block in Femur Fracture Surgery
1 other identifier
interventional
30
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2025
Shorter than P25 for not_applicable
1 active site
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
May 28, 2025
CompletedStudy Start
First participant enrolled
June 1, 2025
CompletedFirst Posted
Study publicly available on registry
June 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2025
CompletedNovember 20, 2025
November 1, 2025
4 months
May 28, 2025
November 17, 2025
Conditions
Keywords
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
EXPERIMENTALParticipants 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.
Control Group
NO INTERVENTIONParticipants 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
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.
Eligibility Criteria
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)
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
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Engin ihsan Turan, Specialist
Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
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