- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07370415
mTLIP vs QIPB for Postoperative Analgesia After Lumbar Instrumentation Surgery
Comparison of Ultrasound-Guided Modified Thoracolumbar Interfascial Plane Block Versus Quadro-Iliac Plane Block for Postoperative Analgesia After Lumbar Instrumentation Surgery
Study Overview
Status
Conditions
Detailed Description
Lumbar instrumentation surgery is commonly associated with moderate-to-severe postoperative pain due to extensive tissue dissection and prolonged muscle retraction. Inadequate pain control may lead to delayed mobilization, increased cardiopulmonary complications, and prolonged hospital stay.
Ultrasound-guided regional analgesia techniques, particularly fascial plane blocks, are increasingly used as part of multimodal analgesia in lumbar spine surgery. The thoracolumbar interfascial plane (TLIP) block is an established technique that provides effective analgesia and has been modified to improve its clinical application, resulting in the modified thoracolumbar interfascial plane (mTLIP) block. Previous studies have demonstrated the effectiveness of mTLIP for postoperative analgesia after lumbar instrumentation surgery.
The quadro-iliac plane block (QIPB) is a recently described ultrasound-guided fascial plane block. Early reports suggest that QIPB may provide effective analgesia in lumbar spine procedures; however, comparative evidence with established techniques remains limited.
This prospective randomized controlled trial aims to compare bilateral ultrasound-guided mTLIP and QIPB performed at the end of surgery in patients undergoing elective lumbar instrumentation surgery under general anesthesia, to evaluate whether QIPB can be considered a safe and effective alternative to mTLIP for postoperative analgesia.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Merih Yildiz Eglen, MD
- Phone Number: +905059340629
- Email: meriheg@yahoo.com
Study Contact Backup
- Name: Mursel Ekinci, Assoc prof MD
- Phone Number: +905067137596
- Email: drmurselekinci@gmail.com
Study Locations
-
-
Bursa
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Nilufer, Bursa, Turkey (Türkiye), 16110
- Bursa City Hospital
-
Contact:
- Merih Yildiz Eglen, MD
- Phone Number: +905059340629
- Email: meriheg@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 65 years
- Classified as American Society of Anesthesiologists physical status I-III
- Scheduled for elective lumbar instrumentation surgery under general anesthesia
- Provision of written informed consent
Exclusion Criteria:
- Use of anticoagulant medications or presence of bleeding diathesis
- Known allergy or hypersensitivity to local anesthetics or opioid drugs
- Infection at the planned block site
- Alcohol or drug dependence
- Cognitive impairment preventing reliable pain assessment
- Pregnancy or lactation
- History of previous lumbar spine surgery
- Diabetes mellitus
- Renal or hepatic insufficiency
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 |
|---|---|
|
Experimental: Modified Thoracolumbar Interfascial Plane Block (mTLIP) Group
Participants in this group will receive a bilateral ultrasound-guided modified thoracolumbar interfascial plane block (mTLIP) performed at the end of lumbar instrumentation surgery while in the prone position.
Under sterile conditions, the ultrasound probe will be placed in the parasagittal plane at the midpoint of the surgical incision, taking into account the operated lumbar levels.
The paraspinal muscles will be identified, and using an in-plane technique, the needle will be advanced into the interfascial plane between the longissimus and iliocostalis muscles.
After confirmation of correct needle placement with saline, 20 mL of 0.25% bupivacaine will be injected on each side.
The block will be performed bilaterally, with a total volume of 40 mL of 0.25% bupivacaine.
|
An ultrasound-guided bilateral fascial plane block in which local anesthetic is injected into the interfascial plane between the longissimus and iliocostalis muscles at the operated lumbar levels.
The block is performed under sterile conditions at the end of surgery using 0.25% bupivacaine (20 mL per side; total volume 40 mL).
|
|
Experimental: Quadro-Iliac Plane Block (QIPB) Group
Participants in this group will receive a bilateral ultrasound-guided quadro-iliac plane block (QIPB) performed at the end of lumbar instrumentation surgery while in the prone position.
Under sterile conditions, a convex ultrasound probe will be placed at the point where the quadratus lumborum muscle attaches to the iliac crest.
The erector spinae and quadratus lumborum muscles will be identified, and correct needle placement will be confirmed with saline injection.
Subsequently, 20 mL of 0.25% bupivacaine will be injected on each side, with visualization of local anesthetic spread between the erector spinae and quadratus lumborum muscles.
The block will be performed bilaterally, with a total volume of 40 mL of 0.25% bupivacaine.
|
An ultrasound-guided bilateral fascial plane block in which local anesthetic is injected at the point where the quadratus lumborum muscle attaches to the iliac crest, allowing spread between the erector spinae and quadratus lumborum muscles.
The block is performed under sterile conditions at the end of surgery using 0.25% bupivacaine (20 mL per side; total volume 40 mL).
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
|
Time of first request for rescue analgesia
Time Frame: Postoperative 48 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.
|
Postoperative 48 hours
|
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Block and Opioid-Related Adverse Effects and Complications
Time Frame: Postoperative 48 hours
|
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
|
Postoperative 48 hours
|
|
Dynamic and static Numeric Rating Scale scores
Time Frame: 0, 2, 4, 8, 16, 24, and 48 hours postoperatively
|
Numeric Rating Scale (NRS) (0-10; 0= no pain, 10 = the most severe pain felt) pain scores at rest or movement at predefined postoperative hours
|
0, 2, 4, 8, 16, 24, and 48 hours postoperatively
|
|
Total rescue analgesic dose
Time Frame: Postoperative 48 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 48 hours
|
|
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.
|
Length of hospital stay will be defined as the number of days from the end of surgery to hospital discharge
|
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.
|
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, Ekinci M. A prospective and randomized trial comparing modified and classical techniques of ultrasound-guided thoracolumbar interfascial plane block. Agri. 2020 Nov;32(4):186-192. doi: 10.14744/agri.2020.72325.
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
- BursaCity Hos 3
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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