Clinical trial NCT07009782: Evaluation of the Postoperative Analgesic Efficacy of the Quadroiliac Plane (QIP) Block in Femur Fracture Surgery
Official title: Evaluation of the Postoperative Analgesic Efficacy of the Quadroiliac Plane (QIP) Block in Femur Fracture Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Femur Fracture
Keywords: Postoperative Pain
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Total Opioid Consumption Within the First 24 Hours Postoperatively
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Rescue Analgesia Requirement
timeFrame: 24 hours
measure: Pain Scores at Rest and on Movement
timeFrame: 0,6,12 and 24 hours
measure: Extent of Dermatomal Coverage Measured by Cold Sensation Response to Alcohol Swab at 2 Hours Post-QIP Block
timeFrame: 2 hours postoperatively
measure: Postoperative Recovery Quality
timeFrame: 24 hours postoperatively
measure: Block-Related Complications
timeFrame: 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
Study officials:
affiliation: Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
name: Engin ihsan Turan, Specialist
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.