Mid-point Transverse Process to Pleura Block Versus Thoracic Paravertebral Block in Posterolateral Thoracotomy
Analgesic Efficacy of Mid-point Transverse Process to Pleura Block Compared With Thoracic Paravertebral Block in Adult Patients Undergoing Posterolateral Thoracotomy Incisions: A Randomized Controlled Study
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interventional
180
1 country
1
Brief Summary
The ultrasound guided Thoracic paravertebral (TPV) block in the context of posterolateral thoracotomy offers targeted pain relief by anesthetizing the spinal nerves as they emerge from the intervertebral foramina, producing ipsilateral somatosensory, visceral and sympathetic nerve blockade. TPV block involves the injection of local anesthetic (LA) into the wedge-shaped paravertebral space deep to the superior costotransverse ligament (SCTL) Costach et al introduced the mid-point transverse process to pleura block (MTP) as a modification of conventional paravertebral block by placing the LA posterior to the (SCTL) under ultrasound guidence achieving an effective block without the necessity to approach the pleura and the attendant risks. In recent studies ,the ultrasound guided MTP block provided an effective analgesia in various surgical procedures including mastectomy , video-assisted thoracic surgeries and cardiac surgeries. In our study we hypothesized that the mid-point transverse process to pleura (MTP) block can provide an effective analgesia comparable with thoracic paravertebral (TPV) block in adult patients undergoing posterolateral thoracotomy incisions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2024
CompletedFirst Submitted
Initial submission to the registry
March 27, 2024
CompletedFirst Posted
Study publicly available on registry
April 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2025
CompletedFebruary 23, 2026
February 1, 2026
1.7 years
March 27, 2024
February 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The total postoperative fentanyl consumption
The total 24 h. fentanyl consumption will be calculated based on the volume remaining in the PCA after 24h based on the following formula : Total fentanyl consumption = (total volume - remaining volume )x 10 .
in the first 24 hours
Secondary Outcomes (11)
Demographic data
24 hours before operation
visual analogue scale score both during rest and with cough
from 30 minutes up to 24 hours postoperative
intra operative fentanyl consumption
from induction of anesthesia to extubation
Duration of surgery
from induction of anesthesia to extubation
Blood pressure
from induction of anesthesia up to 24 hours post operative
- +6 more secondary outcomes
Study Arms (2)
mid-point transverse process to pleura (MTP) block
ACTIVE COMPARATORIn MTP block group, A 22G, 50mm block needle (SONOTAP,Pajunk, -Geisingen,Germany) will be inserted in the cranial to caudal direction via an in-plane approach between the 2 transverse processes and advanced till it reaches the mid-point between the transverse process and pleura. After negative aspiration of blood or air, a total volume of 20 ml of bupivacaine 0.25% ( not exceeding a maximum dose of 2 mg/kg) will be injected superficial to the SCTL
Thoracic Paravertebral (TPV) Block
ACTIVE COMPARATORIn the TPV block group , the transverse process and the pleura will be identified and the needle will be inserted in the cranial to caudal direction till it pierces the SCTL and reaches the paravertebral space. After negative aspiration of blood or air a total volume of 20 ml of bupivacaine 0.25% will be injected displacing the pleura downwards
Interventions
the T1-T12 thoracic spinal levels will be sonographically identified using a high frequency linear US probe (HFL\_50, 15\_6MHz). Then the probe will be placed vertically and nearly 3 cm lateral to the spinous process at the thoracic level T4/T5. The paraspinal muscles (erector spinae, trapezius, rhomboid), transverse processes , superior costo-transverse ligament (SCTL) and parietal pleura will be all identified under parasagittal scanning. In MTP block group, A 22G, 50mm block needle (SONOTAP,Pajunk, -Geisingen,Germany) will be inserted in the cranial to caudal direction via an in-plane approach between the 2 transverse processes and advanced till it reaches the mid-point between the transverse process and pleura. After negative aspiration of blood or air, a total volume of 20 ml of bupivacaine 0.25% ( not exceeding a maximum dose of 2 mg/kg) will be injected superficial to the SCTL.
In the TPV block group , the transverse process and the pleura will be identified and the needle will be inserted in the cranial to caudal direction till it pierces the SCTL and reaches the paravertebral space. After negative aspiration of blood or air a total volume of 20 ml of bupivacaine 0.25% will be injected displacing the pleura downwards
Eligibility Criteria
You may qualify if:
- Patients Scheduled for elective thoracic surgery for pneumectomy, lobectomy, bullectomy or pleural decortication via posterolateral thoracotomy incision.
- American Society of Anesthesiologists (ASA) physical status I-III patients
You may not qualify if:
- Patient refusal.
- Significant renal, hepatic and cardiovascular diseases.
- History of allergy to one of the study drugs.
- Any contraindication to regional anesthesia such as local infection or bleeding disorders.
- Chronic opioid use, history of chronic pain and cognitive disorders.
- Emergent or re-do surgeries
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fayoum University Hospital
Al Fayyum, 63514, Egypt
Related Publications (4)
Costache I, de Neumann L, Ramnanan CJ, Goodwin SL, Pawa A, Abdallah FW, McCartney CJL. The mid-point transverse process to pleura (MTP) block: a new end-point for thoracic paravertebral block. Anaesthesia. 2017 Oct;72(10):1230-1236. doi: 10.1111/anae.14004. Epub 2017 Aug 1.
PMID: 28762464BACKGROUNDChin KJ, Versyck B, Pawa A. Ultrasound-guided fascial plane blocks of the chest wall: a state-of-the-art review. Anaesthesia. 2021 Jan;76 Suppl 1:110-126. doi: 10.1111/anae.15276.
PMID: 33426660BACKGROUNDBhoi D, Narasimhan P, Nethaji R, Talawar P. Ultrasound-Guided Midpoint Transverse Process to Pleura Block in Breast Cancer Surgery: A Case Report. A A Pract. 2019 Feb 1;12(3):73-76. doi: 10.1213/XAA.0000000000000850.
PMID: 30085935BACKGROUNDKahramanlar AA, Aksoy M, Ince I, Dostbil A, Karadeniz E. The Comparison of Postoperative Analgesic Efficacy of Ultrasound-Guided Paravertebral Block and Mid-Point Transverse Process Pleura Block in Mastectomy Surgeries: A Randomized Study. J Invest Surg. 2022 Sep;35(9):1694-1699. doi: 10.1080/08941939.2022.2098544. Epub 2022 Jul 17.
PMID: 35848451BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohamed A Hamed, MD
Fayoum University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The patients will be randomized into two groups: MTP block group and TPV block group in a 1:1 ratio using a computer-generated random table. The patient's assigned group information will be elicited from a sealed opaque envelope by the anesthesiologist who will perform the US-guided MTP and TPV block and will not be involved in further data collection or patient care. The patients and both the surgical and anesthesia teams, who are responsible for patient care and data collection are blinded from the group assignments
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor of Anesthesiology
Study Record Dates
First Submitted
March 27, 2024
First Posted
April 11, 2024
Study Start
March 1, 2024
Primary Completion
November 15, 2025
Study Completion
November 30, 2025
Last Updated
February 23, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share