Clinical Trials Directory

Trials / Completed

CompletedNCT07009782

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
PROCEDUREQIP blockThe 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.

Timeline

Start date
2025-06-01
Primary completion
2025-10-01
Completion
2025-10-15
First posted
2025-06-08
Last updated
2025-11-20

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07009782. Inclusion in this directory is not an endorsement.