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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Cairo, Egypt, 11835
        • Recruiting
        • Cairo University
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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%
Procedure: Mid-transverse process to pleura block combined with erector spinae block
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%.
Procedure: paravertebral block
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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