- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07410000
Ultrasound-Guided Quadro-Iliac Plane Block for Pain Management After Total Hip Arthroplasty
Effectiveness of Ultrasound-Guided Quadro-Iliac Plane Block for Pain Management After Total Hip Arthroplasty: A Prospective Randomized Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Total hip arthroplasty is associated with significant postoperative pain. The Quadro-Iliac Plane (QIP) block is a recently described fascial plane block targeting the area where the quadratus lumborum muscle attaches to the iliac crest and may provide more comprehensive analgesia. This study is designed as a prospective, randomized, double-blind clinical trial including patients aged 18-80 years with ASA physical status I-III undergoing elective primary total hip arthroplasty.
Patients will be randomized into two groups. The QIP group will receive an ultrasound-guided QIP block with 40 mL of 0.25% local anesthetic solution containing epinephrine, and the control group will receive a sham block with 40 mL of 0.9% NaCl using the same technique. The primary outcome is postoperative 24-hour opioid consumption. Secondary outcomes include motor block, and dermatomal sensory assessment, pain scores, quality of recovery (QoR-15), rescue analgesic requirement and opioid-related side effects
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mustafa Dikici, MD
- Phone Number: +905055346540
- Email: mus.dikici88@gmail.com
Study Contact Backup
- Name: Mursel Ekinci, Assoc prof,MD
- Phone Number: +905067137596
- Email: drmurselekinci@gmail.com
Study Locations
-
-
-
Bursa, Turkey (Türkiye), 16110
- Recruiting
- Bursa City Hospital
-
Contact:
- Mustafa Dikici, MD
- Phone Number: +90224975 00 00
- Email: mus.dikici88@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) classification I-III
- Age between 18 and 80 years
- Patients scheduled for elective primary total hip arthroplasty
Exclusion Criteria:
- Refusal to participate in the study
- Allergy to local anesthetics or opioids
- Known or suspected coagulopathy
- Infection at the injection site
- History of previous hip surgery
- Severe cardiovascular disease
- Liver or kidney failure
- Pregnancy, suspected pregnancy, or breastfeeding
- Severe neurological or psychiatric disorder
- Chronic opioid use
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Quadro-Iliac Plane (QIP) Block
Participants in this arm will receive the standard analgesia protocol used for patients undergoing total hip arthroplasty.
In addition to this standard regimen, an ultrasound-guided Quadro-Iliac Plane (QIP) block will be performed in the preoperative period with the patient in the lateral decubitus position.
The technique aims to provide postoperative analgesia by achieving sensory blockade in the relevant dermatomal areas.
|
An ultrasound-guided Quadro-Iliac Plane block performed in the preoperative period.
At the level of the iliac crest, 40 mL of a solution containing 0.25% levobupivacaine and 5 µg/mL epinephrine is injected into the fascial plane between the erector spinae muscle and the quadratus lumborum muscle under aseptic conditions.
Other Names:
|
|
Placebo Comparator: Sham Block (Control)
Participants in this arm will receive the standard analgesia protocol used for patients undergoing total hip arthroplasty.
In addition to this standard regimen, a sham block will be performed using the same ultrasound-guided technique and patient positioning to mimic the block procedure without providing active regional anesthesia.
|
A sham block performed using the same ultrasound-guided technique in the preoperative period.
At the level of the iliac crest, 40 mL of 0.9% NaCl is injected into the fascial plane between the erector spinae muscle and the quadratus lumborum muscle under aseptic conditions.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative 24-Hour Morphine PCA Consumption
Time Frame: Postoperative 24 hours
|
Total amount of morphine delivered by the patient-controlled analgesia (PCA) device during the first 24 hours after surgery, recorded in milligrams (mg).
|
Postoperative 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rescue Analgesic Requirement
Time Frame: Postoperative 0-48 hours
|
Number of patients requiring rescue analgesia (IV meperidine 0.5 mg/kg) and total dose administered when NRS ≥ 4.
|
Postoperative 0-48 hours
|
|
NRS Pain Scores at Rest and Movement
Time Frame: 2, 6, 12, 24, and 48 hours postoperatively
|
Postoperative pain will be assessed using the Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable.
|
2, 6, 12, 24, and 48 hours postoperatively
|
|
QoR-15 Recovery Score
Time Frame: QoR-15 Recovery Score will be evaluated at the postoperative 48th hour
|
The investigators will use the Turkish version of Quality of Recovery (QoR) / QoR-15 questionnaire. PART A How have you been feeling in the last 24 hours? (0 to 10, where: 0 = none of the time [poor] and 10 = all of the time [excellent]) Able to breathe easily Been able to enjoy food Feeling rested Have had a good sleep Able to look after personal toilet and hygiene unaided Able to communicate Getting support from hospital doctors and nurses Able to return to work or usual home activities Feeling comfortable and in control Having a feeling of general well-being PART B Have you had any of the following in the last 24 hours? (10 to 0, where: 10 = none of the time [excellent] and 0 = all of the time [poor]) Moderate pain Severe pain Nausea or vomiting Feeling worried or anxious Feeling sad or depressed [Total score range: 0-150 points] |
QoR-15 Recovery Score will be evaluated at the postoperative 48th hour
|
|
Lower Extremity Muscle Strength Score
Time Frame: Postoperative 6th and 12th hours
|
Postoperative lower extremity muscle strength will be assessed at the 6th postoperative hour using a 0-5 grading scale, where 0 indicates no muscle contraction and 5 indicates normal strength. The scale is defined as follows: 0 = no muscle contraction
|
Postoperative 6th and 12th hours
|
|
Opioid-Related Side Effects
Time Frame: Postoperative 0-48 hours
|
Opioid-related side effects will be assessed postoperatively Other opioid-related side effects, including pruritus, constipation, and somnolence, will be recorded as present or absent. |
Postoperative 0-48 hours
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.
- Selvi O, Azizoglu M, Temel G, Tulgar S, Chitneni A, Cinar EN, Ozer Z, Gurkan Y. Translation and Validation of the Turkish Version of the Quality of Postoperative Recovery Score QoR-15: A Multi-Centred Cohort Study. Turk J Anaesthesiol Reanim. 2022 Dec;50(6):443-448. doi: 10.5152/TJAR.2022.21417.
- Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Girit M, Akin T, Narayanan M, Alici HA. Ultrasound guided quadro-iliac plane block: another novel fascial plane block. Pain Med. 2024 May 3;25(6):370-373. doi: 10.1093/pm/pnae018.
- Carella M, Beck F, Piette N, Denys S, Kurth W, Lecoq JP, Bonhomme VL. Effect of suprainguinal fascia iliaca compartment block on postoperative opioid consumption and functional recovery in posterolateral-approached total hip arthroplasty: a single-blind randomized controlled trial. Reg Anesth Pain Med. 2022 Jun 15:rapm-2021-103427. doi: 10.1136/rapm-2021-103427. Online ahead of print.
- Marrone F, Sorrentino T, Pullano C, Tulgar S. A novel and feasible option for perioperative analgesia in hip fractures surgery: quadro-iliac plane block. Minerva Anestesiol. 2025 Jun;91(6):592-595. doi: 10.23736/S0375-9393.25.18801-9. Epub 2025 Mar 27. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bursa City Hospital 14
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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