- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07370428
US-Guided Quadro-Iliac Plane Block for Postoperative Analgesia After Lumbar Instrumentation (QIPB)
Evaluation of the Effectiveness of Ultrasound-Guided Quadro-Iliac Plane Block in Postoperative Analgesia Management Following Lumbar Instrumentation Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Lumbar instrumentation surgery is associated with significant postoperative pain, which may reduce patient comfort, delay early mobilization, and increase analgesic requirements. Effective postoperative pain management is essential for enhancing recovery and reducing postoperative morbidity. In this context, regional anesthesia techniques have become an important component of multimodal analgesia strategies.
The Quadro-Iliac Plane Block is a newly described ultrasound-guided regional analgesia technique. This block aims to provide effective analgesia by targeting the relevant branches of the lumbar nerves supplying the surgical area. However, clinical evidence regarding its effectiveness in postoperative analgesia following lumbar instrumentation surgery remains limited.
This study aims to evaluate the postoperative analgesic effectiveness of the ultrasound-guided Quadro-Iliac Plane Block in patients undergoing lumbar instrumentation surgery. The findings of this study are expected to contribute to the assessment of this newly developed technique as a safe and effective option for postoperative pain management in lumbar spine surgery.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mursel Ekinci, Assoc prof,MD
- Phone Number: +905067137596
- Email: drmurselekinci@gmail.com
Study Contact Backup
- Name: Merih Yıldız Eglen, MD
- Phone Number: +905059340629
- Email: Meriheg@yahoo.com
Study Locations
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-
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Bursa, Turkey (Türkiye), 16110
- Recruiting
- Bursa City Hospital
-
Contact:
- Merih Yildiz Eglen, MD
- Phone Number: +905059340629
- Email: meriheg@yahoo.com
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Classified as American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective lumbar instrumentation surgery
- Surgery performed under general anesthesia
- Provision of written informed consent
Exclusion Criteria:
- Use of anticoagulant or antiplatelet medications
- Presence of bleeding diathesis or coagulation disorders
- Known allergy or hypersensitivity to local anesthetics or opioid medications
- Infection at the planned block site
- Alcohol or drug dependence
- Cognitive impairment preventing reliable pain assessment using the NRS
- Pregnancy or lactation
- History of previous lumbar spine surgery
- Diabetes mellitus
- Renal or hepatic impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Group Control
|
|
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Active Comparator: Group QIPB
Participants in this arm will receive an ultrasound-guided Quadro-Iliac Plane Block. The block will be performed at the end of surgery, before extubation, with the patient in the prone position under standard sterilization conditions. A convex ultrasound probe will be placed at the level where the quadratus lumborum muscle (QLM) attaches to the iliac crest to visualize the erector spinae muscle (ESM) and the underlying QLM. The block location will be confirmed by injecting 2 mL of isotonic solution at the QLM-iliac crest junction. Subsequently, 20 mL of 0.25% bupivacaine will be injected, and the spread of the local anesthetic between the ESM and QLM will be observed under ultrasound guidance. The block will be performed bilaterally with a total volume of 40 mL. |
Ultrasound-guided regional anesthesia technique performed between the erector spinae muscle and the quadratus lumborum muscle at the iliac crest level.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative 48-Hour PCA Opioid Consumption
Time Frame: Postoperative 0-8, 8-16, 16-24, 24-48 intervals
|
Total amount of opioid delivered by the patient-controlled analgesia (PCA) device during the first 48 hours after surgery, recorded in milligrams (mg).
|
Postoperative 0-8, 8-16, 16-24, 24-48 intervals
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|
QoR-15 Recovery Score
Time Frame: Postoperative 24th and 48th hours
|
The investigators will use the Turkish version of Quality of Recovery (QoR) / QoR-15 questionairre 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 with 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 |
Postoperative 24th and 48th hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total rescue analgesic dose
Time Frame: Postoperative 24th and 48th hours
|
Despite the use of patient-controlled analgesia (PCA), if the Numeric Rating Scale (NRS) score is ≥4 at any time point, 0.5 mg/kg intravenous meperidine will be administered as rescue analgesia. Total amount of meperidin during the first 24 and 48 hours after surgery, recorded in milligrams (mg). |
Postoperative 24th and 48th hours
|
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Dynamic and static NRS scores
Time Frame: 0, 2, 4, 8, 16, 24, and 48 hours postoperatively
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Numeric Rating Scale (NRS) (0-10) pain scores at rest or movement at predefined postoperative hours
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0, 2, 4, 8, 16, 24, and 48 hours postoperatively
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Time of first request for rescue analgesia
Time Frame: Postoperative 48-Hours
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Despite the use of patient-controlled analgesia (PCA), if the Numeric Rating Scale (NRS) score is ≥4 at any time point, 0.5 mg/kg intravenous meperidine will be administered as rescue analgesia.
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Postoperative 48-Hours
|
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Length of Hospital Stay
Time Frame: Patients will remain under observation for at least 2 weeks until their postoperative discharge. Follow-up will be completed upon discharge. The length of hospital stay will be recorded (day).
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Length of hospital stay will be defined as the number of days from the end of surgery to hospital discharge.
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Patients will remain under observation for at least 2 weeks until their postoperative discharge. Follow-up will be completed upon discharge. The length of hospital stay will be recorded (day).
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Block and Opioid-Related Adverse Effects and Complications
Time Frame: Postoperative 48-Hours
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Block- and opioid-related adverse effects and complications, including but not limited to local anesthetic toxicity, hematoma, infection, nerve injury, nausea, vomiting, pruritus, sedation, and respiratory depression, will be recorded
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Postoperative 48-Hours
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- Turan EI, Sahin AS. Quadro-iliac plane block (QIPB) in lumbar stabilisation surgeries: A case series. Indian J Anaesth. 2025 Feb;69(2):244-245. doi: 10.4103/ija.ija_1077_24. Epub 2025 Jan 29. No abstract available.
- Ciftci B, Cetinkal A, Alver S, Ahiskalioglu A. Quadro-iliac plane block for lumbar multi-level instrumentation surgery: far away from the surgical area. Minerva Anestesiol. 2025 Apr;91(4):358-359. doi: 10.23736/S0375-9393.24.18680-4. Epub 2024 Dec 10. 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
- BursaCityHOS 1
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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