- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07695987
Quadro-Iliac Plane Block for Analgesia After Lumbar Microdiscectomy (QIPB RCT)
Effect of Ultrasound-Guided Quadro-Iliac Plane Block Compared With Local Infiltration Analgesia After Single-Level Lumbar Microdiscectomy: A Prospective, Double-Blind, Controlled, Multicenter Randomized Trial
This study will evaluate whether ultrasound-guided quadro-iliac plane block provides better postoperative pain control than local infiltration analgesia in patients undergoing single-level lumbar microdiscectomy.
Adult patients scheduled for elective single-level lumbar microdiscectomy will be randomly assigned to receive either bilateral quadro-iliac plane block plus patient-controlled analgesia or local infiltration analgesia plus patient-controlled analgesia. The main outcome of the study will be total fentanyl consumption during the first 24 hours after surgery. Pain scores, need for rescue analgesia, opioid-related side effects, patient satisfaction, and recovery quality will also be evaluated.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a prospective, randomized, double-blind, controlled, multicenter clinical trial designed to assess the analgesic efficacy of ultrasound-guided quadro-iliac plane block in patients undergoing elective single-level lumbar microdiscectomy.
Patients aged 18-75 years with American Society of Anesthesiologists physical status I-III who are scheduled for elective single-level lumbar microdiscectomy under general anesthesia will be included. Participants will be randomized into two groups. The intervention group will receive bilateral ultrasound-guided quadro-iliac plane block before emergence from anesthesia, followed by postoperative patient-controlled analgesia. The control group will receive local infiltration analgesia performed by the surgeon, followed by postoperative patient-controlled analgesia.
All patients will receive a standardized general anesthesia protocol. Postoperative analgesia will be provided using a fentanyl-based patient-controlled analgesia device. The primary outcome will be total fentanyl consumption during the first postoperative 24 hours. Secondary outcomes will include numerical rating scale pain scores at predefined postoperative time points, rescue analgesic requirement, opioid-related adverse effects such as nausea, vomiting, pruritus and respiratory depression, dermatomal sensory spread, and patient-reported recovery quality using the QoR-15 questionnaire.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Engin ihsan Turan, principal investigator
- Phone Number: +905382431114
- Email: drenginihsan@gmail.com
Study Locations
-
-
Istanbul
-
Istanbul, Istanbul, Turkey (Türkiye), 34303
- Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 to 75 years
- American Society of Anesthesiologists physical status I to III
- Scheduled for elective single-level lumbar microdiscectomy, such as L4-L5 or L5-S1 disc herniation
- Planned surgery under general anesthesia
- Able to provide written informed consent
Exclusion Criteria:
- Allergy or hypersensitivity to local anesthetics
- Coagulopathy or active anticoagulant use
- Infection, scar tissue, or skin lesion at the injection site
- Pregnancy or breastfeeding
- Chronic pain syndrome or regular opioid use
- American Society of Anesthesiologists physical status IV or higher
- Planned surgery for two or more levels of disc herniation
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 |
|---|---|
|
Active Comparator: Quadro-Iliac Plane Block Group
Participants in this group will receive bilateral ultrasound-guided quadro-iliac plane block before emergence from general anesthesia, followed by postoperative fentanyl-based patient-controlled analgesia.
|
Bilateral ultrasound-guided quadro-iliac plane block will be performed before emergence from general anesthesia in the prone position.
After visualization of the quadratus lumborum muscle and iliac crest at the L3 level, 30 mL of 0.167% bupivacaine will be injected into the interfascial plane on each side.
All participants will receive postoperative fentanyl-based patient-controlled analgesia.
|
|
Active Comparator: Local Infiltration Analgesia Group
Participants in this group will receive surgeon-performed local infiltration analgesia, followed by postoperative fentanyl-based patient-controlled analgesia.
|
Local infiltration analgesia will be performed by the surgeon before the end of surgery.
A total dose of 50 mg of 0.25% bupivacaine will be infiltrated into the subcutaneous tissue.
All participants will receive postoperative fentanyl-based patient-controlled analgesia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Fentanyl Consumption During the First 24 Hours After Surgery
Time Frame: Postoperative 0-24 hours
|
Total postoperative fentanyl consumption administered via patient-controlled analgesia will be recorded during the first 24 hours after surgery.
|
Postoperative 0-24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Scores at Rest and During Movement
Time Frame: Postoperative 0, 1, 6, 12, and 24 hours
|
Pain intensity will be assessed using the Numerical Rating Scale at rest and during movement.
The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
|
Postoperative 0, 1, 6, 12, and 24 hours
|
|
Rescue Analgesic Requirement
Time Frame: Postoperative 0-24 hours
|
The need for rescue analgesia with intravenous tenoxicam will be recorded during the postoperative follow-up period.
|
Postoperative 0-24 hours
|
|
Opioid-Related Adverse Effects
Time Frame: Postoperative 0-24 hours
|
Opioid-related adverse effects, including nausea, vomiting, pruritus, and respiratory depression, will be recorded.
|
Postoperative 0-24 hours
|
|
Quality of Recovery Score
Time Frame: Postoperative 24 hours
|
Patient-reported recovery quality will be assessed using the Quality of Recovery-15 questionnaire.
|
Postoperative 24 hours
|
|
Dermatomal Sensory Spread
Time Frame: Postoperative 2 hours
|
Dermatomal sensory spread of the block will be evaluated using a cold test.
|
Postoperative 2 hours
|
Collaborators and Investigators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Quadroiliac plane block RCT
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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