- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06851533
Comparing Thoracolumbar Interfascial and Quadro Iliac Plane Blocks on Postoperative Opioid Use Following Lumbar Microsurgery
Comparison of the Effects of Thoracolumbar Interfascial Plane Block and Quadro Iliac Plane Block on Postoperative Opioid Consumption After Lumbar Microsurgery: A Randomized Controlled Trial
Lumbar microdiscectomy is a commonly used surgical procedure for treating herniated discs. Effective postoperative analgesia is crucial for early mobilization and functional recovery. Uncontrolled postoperative pain can delay recovery, increase the risk of opioid dependence, and lead to respiratory complications.
Although opioid analgesics effectively reduce pain, they can cause side effects such as nausea, vomiting, respiratory depression, and dependency. Therefore, non-opioid analgesic methods are preferred for patient safety and comfort. Recently, regional anesthesia techniques such as the Thoracolumbar Interfascial Plane (TLIP) block and the Quadro Iliac Plane Block have been introduced for postoperative pain management in lumbar surgeries. However, there are not enough studies comparing the superiority of these two methods.
Study Objective: The primary aim of this study is to evaluate the effects of ultrasound-guided TLIP and Quadro Iliac Plane Blocks on postoperative opioid consumption after lumbar microsurgery. The secondary aim is to compare opioid-related side effects (such as nausea, vomiting, respiratory depression, etc.) and postoperative NRS pain scores between the groups.
Study Overview
Status
Conditions
Detailed Description
Lumbar microdiscectomy is a widely performed surgical procedure for the treatment of lumbar disc herniation. Ensuring optimal analgesia during the postoperative period is crucial for promoting functional recovery and early mobilization. Inadequate control of postoperative pain may delay the healing process, increase the risk of opioid dependence, and lead to respiratory complications.
Although opioid analgesics are effective in alleviating pain during the postoperative period, they can cause adverse effects such as nausea, vomiting, respiratory depression, and an increased risk of dependence. Therefore, the implementation of non-opioid analgesic strategies is essential for maintaining patient safety and comfort. In recent years, regional anesthesia techniques, including the Thoracolumbar Interfascial Plane block and the Quadro Iliac Plane Block, have been utilized for postoperative pain management in lumbar surgeries. However, there is insufficient evidence directly comparing the effectiveness of these two methods.
Purpose of the Study: The primary objective of this study is to evaluate the impact of ultrasound-guided Thoracolumbar Interfascial Plane and Quadro Iliac Plane Blocks on postoperative opioid consumption following lumbar microsurgery. Additionally, the secondary objective is to compare the incidence of opioid-related side effects (such as nausea, vomiting, and respiratory depression) and patients' postoperative pain scores, measured using the Numeric Rating Scale, between the two groups.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Burak Ömür
- Phone Number: +905056215056
- Email: burakomur@outlook.com
Study Locations
-
-
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Istanbul, Turkey (Türkiye)
- Recruiting
- Medipol University
-
Contact:
- Burak Ömür
- Phone Number: +905056215056
- Email: burakomur@outlook.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged 18 to 80 years
- American Society of Anesthesiologists (ASA) physical status I to III
- scheduled for lumbar microdiscectomy surgery
Exclusion Criteria:
- Known allergy to local anesthetics
- Any other significant drug allergies related to the study interventions
- Pregnancy
- Pre-existing psychiatric or neurological disorders
- Inability to provide informed consent
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: No Block (Control Group)
Patients receive standard perioperative analgesia without any additional regional block.
|
Participants receive standard perioperative analgesia (including intravenous paracetamol/tramadol), but no additional regional block is applied.
|
|
Experimental: TLIP Block
Patients receive the Thoracolumbar Interfascial Plane (TLIP) block in addition to standard perioperative analgesia.
|
In addition to standard perioperative analgesia, a TLIP block is performed under sterile conditions and ultrasound guidance, after the surgical procedure is completed but before the patient is awakened.
A total of 20 mL of 0.25% bupivacaine is injected into the thoracolumbar fascial plane, and spread is confirmed via ultrasound.
|
|
Experimental: Quadro Iliac Plane Block
Patients receive the Quadro Iliac Plane Block in addition to standard perioperative analgesia.
|
In addition to standard perioperative analgesia, a Quadro Iliac Plane Block is performed under sterile conditions and ultrasound guidance, after the surgical procedure is completed but before the patient is awakened.
A total of 20 mL of 0.25% bupivacaine is injected into the quadro iliac plane at the level of the iliac crest, and spread is confirmed via ultrasound.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
tramadol consumption
Time Frame: first 24 hours after the operation
|
Total tramadol consumption (mg) in the first 24 hours after surgery.
|
first 24 hours after the operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NRS (Numerical Rating Scale) pain scores
Time Frame: first 24 hours after the operation
|
NRS (0-10) scores will be measured at 3, 6, 12, 18, and 24 hours during both rest and mobilization in the postoperative period.
|
first 24 hours after the operation
|
|
opioid-related side effects (such as nausea, vomiting, respiratory depression)
Time Frame: first 24 hours after the operation
|
The incidence of opioid-related side effects (e.g., nausea, vomiting, respiratory depression) will be recorded and compared between groups.
|
first 24 hours after the operation
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Canikli Adiguzel S, Akyurt D, Bahadir Altun H, Ultan Ozgen G, Akdeniz S, Bayraktar B, Tulgar S, Yigit Y. Posterior Quadratus Lumborum Block or Thoracolumbar Interfascial Plane Block and Postoperative Analgesia after Spinal Surgery: A Randomized Controlled Trial. J Clin Med. 2023 Nov 21;12(23):7217. doi: 10.3390/jcm12237217.
- Hu Z, Han J, Jiao B, Jiang J, Sun Y, Lv Z, Wang J, Tian X, Wang H. Efficacy of Thoracolumbar Interfascial Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: A Meta-analysis of Randomized Clinical Trials. Pain Physician. 2021 Nov;24(7):E1085-E1097.
- Yildirim Uslu E. Effect of Quadratus Lumborum Block in Patients With Acute-Subacute Unilateral Lumbar Strain. Cureus. 2024 May 24;16(5):e61014. doi: 10.7759/cureus.61014. eCollection 2024 May.
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
- Lumbar tlip vs quadroilaac
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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