NCT06361121

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

1.7 years

First QC Date

March 27, 2024

Last Update Submit

February 19, 2026

Conditions

Keywords

Mid-point Transverse Process to Pleura BlockPosterolateral Thoracotomy Incisions

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 COMPARATOR

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

Procedure: mid-point transverse process to pleura (MTP) block

Thoracic Paravertebral (TPV) Block

ACTIVE COMPARATOR

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

Procedure: Thoracic Paravertebral Block

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.

mid-point transverse process to pleura (MTP) block

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

Thoracic Paravertebral (TPV) Block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 28762464BACKGROUND
  • Chin 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: 33426660BACKGROUND
  • Bhoi 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: 30085935BACKGROUND
  • Kahramanlar 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

BronchiectasisLung Neoplasms

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung Diseases

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Mohamed A Hamed, MD

    Fayoum University Hospital

    PRINCIPAL INVESTIGATOR

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

Locations