- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06618599
Mid-transverse Process Combined With Erector Spinae Block Versus Paravertebral Plane Block
August 29, 2026 updated by: Sayed Mahmoud Abed, Cairo University
Analgesic Effect of Mid-transverse Process to Pleura Block Combined With Erector Spinae Block Versus Paravertebral Plane Block in Thoracic Surgery for Lung Cancer Patients
This study aims to compare efficacy of Mid-transverse process to pleura block combined with erector spinae block versus paravertebral plane block in cancer patients undergoing thoracotomy surgeries.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Thoracic paravertebral block (TPVB) application has also been used in recent years due to the lower incidence of side effects.
The erector spinae plane block (ESPB)has been used as a part of multimodal analgesia in recent years.
In ESPB is aimed to treat the postoperative pain of the thoracoabdominal region by injecting a local anesthetic into the interfacial area under the erector spinae muscle .
ESPB creates an effect that covers the posterior and lateral thorax by affecting the dorsal rami and branches of the spinal nerves .
Midtransverse process to pleura (MTP) block is less invasive as the position of the needle in this block is midway between the transverse process' posterior border and the pleura.
Due to fenestrations present in the superior costotransverse ligament (SCTL), the drug reaches the paravertebral space
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: sayed M abed, MD degree
- Phone Number: +201226806532
- Email: sydabed2020@outlook.com
Study Locations
-
-
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Cairo, Egypt, 11835
- Recruiting
- Cairo University
-
Contact:
- sayed M abed, MD degree
- Phone Number: +201226806532
- Email: sydabed2020@outlook.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- lung cancer patients for thoracotomy surgeries.
- Physical status American Society of Anesthesiologists (ASA )II, III.
- Age ≥ 18 and ≤ 65 Years.
- Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2
Exclusion Criteria:
- Patient refusal
- physical status ASA IV,
- Age <18 years or >65 years
- BMI < 20 kg/m2 and >35 kg/m2
- Known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).
- History of psychological disorders and/or chronic pain.
- Contraindication to regional anesthesia e.g., local sepsis, pre- existing peripheral neuropathies, and coagulopathy.
- Severe respiratory, cardiac, hepatic or renal disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Group 1:midtransverse to pleura block combined with erector spinae block
Patients received ipsilateral Ultrasound guided midtransverse block with injection of 20 ml bupivacaine 0.25% and ipsilateral Ultrasound guided ESPB block with injection of 20 ml bupivacaine 0.25%
|
The probe will be placed vertically 3 cm lateral to the T5 spinous process and the transverse process will be identified.
The needle will be introduced in an in-plane fashion until the tip lay deep in the erector spinae muscle.
One milliliter of normal saline will be injected to confirm the correct needle tip position by visualizing the spread under the erector spinae muscle.
20 mL of 0.25% bupivacaine will be injected .The needle will be directed aiming for the midpoint between the transverse process and pleura from cephalad to caudad.
One milliliter of normal saline will be given to confirm the position of the needle tip, then a total of 20 ml of 0.25% ropivacaine will be injected
|
|
Experimental: Group 2: paravertebral block
Patients received ipsilateral Ultrasound guided paravertebral plane block with injection of 30 ml bupivacaine 0.25%.
|
the transducer will be positioned laterally 3 cm to the midline at T5 spinous process, defining the spinous process, pleura, transverse process, the paravertebral (PV) space, and superior costotransverse ligament.
The trapezius, rhomboid major, and erector spinae muscles will be recognized as superficial to the hyperechoic transverse process shadow.
However, when the rhomboid major muscle disappeared, this indicated that we will be at the 7th thoracic vertebra's level.
Local infiltration using 2-3 mL of 2.0% lignocaine will be done.
A spinal 22-gauge needle will be injected at the cephalic side of the transducer using an in-plane technique, and the needle directed towards the costotransverse ligament (CTL).
The passage of the needle through the CTL will be associated with a pop, informing that the superior costotransverse ligament will be passed.
Following a 3 mL testing dose of normal saline containing epinephrine (1:200,000), 30 mL bupivacaine 0.25% injected.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
visual analogue score changes during rest and cough for the three groups.
Time Frame: for 24 hours postoperative
|
the score of visual analogue score, with minimum score of 0 and maximum of 10, with higher scores meaning more severe pain
|
for 24 hours postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: sayed M Abed, Cairo University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.
- Zengin M, Alagoz A. Comparison of Thoracic Epidural Analgesia and Thoracic Paravertebral Block Applications in the Treatment of Acute Pain After Thoracotomy in Geriatric Patients. Cureus. 2021 Oct 22;13(10):e18982. doi: 10.7759/cureus.18982. eCollection 2021 Oct.
- Liu L, Ni XX, Zhang LW, Zhao K, Xie H, Zhu J. Effects of ultrasound-guided erector spinae plane block on postoperative analgesia and plasma cytokine levels after uniportal VATS: a prospective randomized controlled trial. J Anesth. 2021 Feb;35(1):3-9. doi: 10.1007/s00540-020-02848-x. Epub 2020 Sep 4.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2024
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Study Registration Dates
First Submitted
September 26, 2024
First Submitted That Met QC Criteria
September 26, 2024
First Posted (Actual)
October 1, 2024
Study Record Updates
Last Update Posted (Actual)
September 1, 2026
Last Update Submitted That Met QC Criteria
August 29, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- analgesia in thoracotomy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
starting from march 2025
IPD Sharing Time Frame
basal
IPD Sharing Access Criteria
web
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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