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

Not Applicable

Recruiting

• Conditions: Femur Fracture

• Registration Number: NCT07009782
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

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).

Study Timeline

• Study First Submitted: 2025-05-28
• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted QC: 2025-06-05
• Study First Posted: 2025-06-08
• Last Update Submitted: 2025-06-25
• Last Update Posted: 2025-06-29
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total Opioid Consumption Within the First 24 Hours Postoperatively	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.

Secondary Outcome Measures

Name	Time	Method
Rescue Analgesia Requirement	24 hours	The number of patients who require additional rescue analgesia (50 mg intravenous dexketoprofen) within the first 24 hours postoperatively will be recorded.
Pain Scores at Rest and on Movement	0,6,12 and 24 hours	Pain intensity will be measured using the Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Assessments will be conducted both at rest and during movement at 0, 6, 12, and 24 hours after surgery. Higher scores indicate worse pain.
Extent of Dermatomal Coverage Measured by Cold Sensation Response to Alcohol Swab at 2 Hours Post-QIP Block	2 hours postoperatively	Dermatomal spread will be assessed using an alcohol-based cold test 2 hours after administration of the Quadroiliac Plane (QIP) Block. A trained clinician will apply alcohol-soaked gauze to the skin in a cranio-caudal direction along the abdomen and hip region. The patient will be asked to report changes in cold sensation compared to unblocked areas. The lowest and highest dermatomes with altered cold sensation (reduced or absent) will be recorded for each side.
Postoperative Recovery Quality	24 hours postoperatively	Patients will complete the Quality of Recovery-15 (QoR-15) questionnaire 24 hours after surgery to evaluate their postoperative recovery experience. The QoR-15 consists of 15 items, each scored from 0 to 10, resulting in a total score range of 0 to 150. Higher scores indicate better recovery and a more favorable patient-reported outcome
Block-Related Complications	24 hours	Any complications or side effects related to the QIP block (e.g., motor block, hematoma, infection) will be recorded.

Trial Locations

Locations (1)

Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital; 🇹🇷 Istanbul, Turkey