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NCT Number: NCT06888258

Compare Analgesia Between MTP Block And ESPB in MRM

This study is conducted to compare the analgesic efficacy between ultrasound guided Erector Spinae Plane block Vs midpoint transverse process to Pleura block in modified radical mastectomy surgeries

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National cancer institute, Cairo University

Cairo, 11796, Egypt

Location status: Recruiting

Location contact

Zainab Korany

CONTACT

[email protected]

+20 10 21419716

About this study

Patients participants will be randomized into 3 groups:

Group M (mid-point transverse process to pleura block MTP) N=3o Patients will receive Ultrasound guided mid-point transverse process to pleura block preoperative with injection of 20 ml bupivacaine 0.25%.

Group M: The block will be performed preoperatively with full aseptic precautions. The ultrasound probe will be placed on the back in a vertical orientation on the lateral side of the posterior median line to identify the transverse processes of the 4th and 5th thoracic vertebrae and pleura.

A skin wheal using 3ml of 1% lidocaine will be made 2 to 3 cm superior to the superior aspect of the transducer. Using the in plane needling technique in the space between the transverse processes of the 4th and 5th thoracic vertebrae, the puncture needle needle tip will be placed at the mid-point between the transverse process and pleura, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% bupivacaine will be administered. The local anesthetic spread will be noted in the area midway between the transverse process and pleura is an indication of a successful puncture.

Group E (Erector Spinae Plane Block ESB) N=3o Patients will receive Ultrasound guided erector spinae plane block with injection of 20 ml bupivacaine 0.25%.

Group E: The block will be performed preoperatively with full aseptic precautions. The ultrasound probe will be placed on the back in a vertical orientation on the lateral side of the posterior median line to identify the transverse process of the 5th thoracic vertebra and erector spine muscle.

A skin wheal using 3ml of 1% lidocaine will be made 2 to 3 cm superior to the superior aspect of the transducer. The puncture will be performed using the intra-plane needling technique after local anaesthesia infiltration. A 20-gauge Tuohy needle connected to a syringe containing the anesthetic mixture or saline will be advanced. When the puncture needle touch the transverse process, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% bupivacaine will be administered between the erector spine muscle and transverse process.

Local anesthetic diffusion between the transverse process and erector spinae muscle is an indication of a successful puncture.

Group C (control group) N=30 Patients will not receive any block. Induction will be performed by using a regimen of IV by fentanyl 1 μg/kg, Additional bolus doses of fentanyl 0.5 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.

Randomization will be done by statistician and each group of the patient will revealed only when the included patient is transferred to preanesthetic room.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I-II.
  • Undergoing modified radical mastectomy surgery.
  • Body mass index (BMI) from 18.5 to 30 kg/m2

Exclusion criteria

  • Patient refusal.
  • Known allergy to local anesthetics.
  • Bleeding disorders; platelets count <50,000 , prothrombin concentration < 60% or any coagulopathy disorder.
  • Use of any anti-coagulants.
  • Inability to provide informed consent.
  • ASA III-IV.
  • Neurological disorders.
  • Patient with psychiatric disorders

Treatment and study plan

Ultrasound guided Erector Spinae Plane block

Procedure

Group E: The block will be performed preoperatively with full aseptic precautions. The ultrasound probe will be placed on the back in a vertical orientation on the lateral side of the posterior median line to identify the transverse process of the 5th thoracic vertebra and erector spine muscle.

A skin wheal using 3ml of 1% lidocaine will be made 2 to 3 cm superior to the superior aspect of the transducer. The puncture will be performed using the intra-plane needling technique after local anaesthesia infiltration. A 20-gauge Tuohy needle connected to a syringe containing the anesthetic mixture or saline will be advanced. When the puncture needle touch the transverse process, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% bupivacaine will be administered between the erector spine muscle and transverse process.

Local anesthetic diffusion between the transverse process and erector spinae muscle is an indication of a successful puncture.

Ultrasound guided Mid-point to Pleura block

Procedure

Group M: The block will be performed preoperatively with full aseptic precautions. The ultrasound probe will be placed on the back in a vertical orientation on the lateral side of the posterior median line to identify the transverse processes of the 4th and 5th thoracic vertebrae and pleura.

A skin wheal using 3ml of 1% lidocaine will be made 2 to 3 cm superior to the superior aspect of the transducer. Using the in plane needling technique in the space between the transverse processes of the 4th and 5th thoracic vertebrae, the puncture needle needle tip will be placed at the mid-point between the transverse process and pleura, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% bupivacaine will be administered. The local anesthetic spread will be noted in the area midway between the transverse process and pleura is an indication of a successful puncture.

Primary outcomes

  1. post-operative opioid (morphine) consumption in the 1st 24 hours

    Time frame: 24 hours

    Total post operative morphine dosage in mg required

Secondary outcomes

  1. Time to first rescue analgesia, starting after extubation. In minutes

    Time frame: 24 hours

    When was the first rescue analgesia given

  2. Total dose of fentanyl required intraoperative (including induction dose) in microgram

    Time frame: 24 hours

    Total fentanyl dose given intraoperative

  3. Numerical pain rating score at 15, 30, 45 and 60 min., 3,6,12 and 24 h after surgery. Score from 0 to 10 where 10 is the worst pain

    Time frame: 24 hours

    Pain score post operative

  4. Change in heart rate (rate per minute) intraoperatively at 30 minutes interval in comparison to baseline reading.

    Time frame: 24 hours

    Change in vital data intraoperative

  5. Change mean arterial blood pressure (mmHg) intraoperatively at 30 minutes interval in comparison to baseline reading.

    Time frame: 24 hours

    Change in vital data intraoperative

  6. Heart rate (per minute) at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively

    Time frame: 24 hours

    Post operative vital data

  7. Mean arterial blood pressure (mmHg) at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively

    Time frame: 24 hours

    Post operative vital data

Study contacts

Contact information is provided by the study sponsor or research team.

mahmoud Saad Mahmoud Mohamed Mohamed, Msc

CONTACT

[email protected]

+201094555375

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Registry information

Official study title

Comparative Study Between Ultrasound Guided Mid-point Transverse Process to Pleura Block And Erector Spinae Plane Block For Perioperative Analgesia In Modified Radical Mastectomy In Breast Cancer Patients

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 21, 2025
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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