- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07233746
Comparison of QIPB and SIFICB in Hip Surgery
Comparison of the Effects of Quadroiliac Plane Block Versus Suprainguinal Fascia Iliaca Compartment Block on Postoperative Pain in Hip Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: OĞUZ GÜNDOĞDU
- Phone Number: +905545945469
- Email: droguzgundogdu@gmail.com
Study Contact Backup
- Name: MAHMUT K DEMİRCİ
- Phone Number: +905389700697
- Email: mkdemirci1@gmail.com
Study Locations
-
-
Sivas
-
Sivas, Sivas, Turkey (Türkiye), 58140
- Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients over 18 years of age who underwent percutaneous nephrolithotomy under general anesthesia and were I-II-III according to the American Society of Anesthesiologists (ASA) risk classification were included in the study.
Exclusion Criteria:
patients who did not give consent,
- patients with coagulopathy,
- patients with signs of infection at the block application site,
- patients using anticoagulants,
- patients with known allergies to any of the study drugs,
- patients with unstable hemodynamics,
- patients who could not cooperate during postoperative pain assessment
- patients who wanted to withdraw from the study,
- patients with alcohol and drug addiction,
- patients with musculoskeletal abnormalitie
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Quadro-İliac Plane Block(QİPB)
For this group, after the surgical procedure is completed, the patient will be placed in a lateral position with the operated side facing up, and a QIPB will be performed.
With the patient in the lateral position, the spinous process of the L3 vertebra will first be imaged with an ultrasound probe positioned transversely in the midline.
Then, by slightly shifting the probe laterally, the transverse process of the vertebra will be visualized within the erector spinae muscle.
The probe will then be rotated in the sagittal plane and advanced caudally about 1 cm, visualizing the crista iliaca.
On the cranial side of the crista iliaca, the erector spinae muscle, quadratus lumborum, and psoas major muscles will be visualized sequentially.
With the needle direction cranial to caudal, the crista iliaca will be gently touched, and the needle will be positioned between the erector spinae and the quadratus lumborum muscle.
After injecting 40 ml of 0.25% bupivacaine, the needle will be injected.
|
40 mL of 0.25% bupivacaine
|
|
Active Comparator: Suprainguinal Fascia Iliaca Compartiment Block (SIFICB)
Probe Placement: A high-frequency linear ultrasound probe is placed in a sagittal orientation over the Anterior Superior Iliac Spine (ASIS) and then moved medially. Anatomical Landmark: The key visual target on the ultrasound screen is the "bowtie" sign, which is formed by the junction of the sartorius and internal oblique muscles over the iliacus muscle.Injection Point: The target for injection is the potential space located directly beneath the fascia iliaca (seen as a bright, hyperechoic line) and superficial to the iliacus muscle.Needle Insertion: The block needle is advanced using an "in-plane" technique (parallel to the probe's long axis), typically from a caudal-to-cranial direction (from bottom to top).Injection: After confirming correct needle tip placement with hydrodissection (visualizing fluid separating the fascia from the muscle), 30-40 mL of local anesthetic is slowly injected. The spread of the anesthetic proximally (upward) beneath the fascia is monitored in real-time |
30 mL of 0.25% bupivacaine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Rating Scale (NRS) Scores
Time Frame: Postoperative 24 hours
|
Numerical rating scale is used for pain assessment.
The scores of the numerical rating scale changes between 0 to 10 points.
10 points mean "the most severe pain that the patient ever had".
0 point means "there is no pain."
Higher scores mean worse outcome.
|
Postoperative 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total tramadol consumption
Time Frame: Postoperative 24 hours
|
Postoperative total analgesic need was recorded as "milligram" in unit.
|
Postoperative 24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: OĞUZ GÜNDOĞDU, Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
- Study Chair: MAHMUT K DEMİRCİ, Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-07/23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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