Ultrasound-guided Thoracic Interfascial Plane Nerve Block Versus Erector Spinae Plane Block for Pain Control After Modified Radical Mastectomy

January 9, 2025 updated by: Safie ramez tewfeik abd el moneim

Ultrasound-guided Thoracic Interfascial Plane Nerve Block Versus Erector Spinae Plane Block for Postoperative Pain Control in Patients Undergoing Modified Radical Mastectomy

This study compares two methods of local pain control in patients undergoing Modified Radical Mastectomy, a common surgery for breast cancer( tumor in the breast) treatment. It aims to determine which method, the Thoracic Interfascial Plane Block or the Erector Spinae Plane Block, provides better pain relief after surgery, reduces side effects, and increases patient satisfaction.

Why This Study Is Important:

Breast cancer surgery can cause significant pain, and managing this pain is important for a quick recovery. Currently, pain is often managed with opioids, which can cause side effects like nausea and drowsiness. invistigators want to find a method that controls pain effectively with fewer side effects, helping patients recover faster and feel better.

Who Can Take Part:

Women aged 21 and older who are scheduled for a Modified Radical Mastectomy at Ain Shams University hospitals can participate in this study.

What Will Happen During the Study:

Participants will be randomly assigned to receive either the Thoracic Interfascial Plane Block or the Erector Spinae Plane Block before surgery.

Pain levels will be measured using a numerical pain score from 1 to 10. Researchers will track the amount of pain medication needed, the time it takes to feel pain relief, and any side effects.

Other factors such as sleep quality, time to start walking again, and overall satisfaction with pain control will also be recorded.

What investigators hope to Learn:

Investigators hope to find out which nerve block provides better pain relief after surgery. By comparing TIPB and ESPB, with the aim to identify the method that:

Requires less additional pain medication Has fewer side effects Improves sleep quality and overall recovery Increases patient satisfaction

Significance:

This study could lead to better pain management strategies for breast cancer surgery, reducing the need for opioids and enhancing patient recovery and comfort.

Participation:

Participants will be monitored closely during and after the procedure to ensure their safety and well-being. The results of this study could help improve pain management for future patients undergoing similar surgeries.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized, double-blinded clinical trial comparing the efficacy of two ultrasound-guided nerve blocks for postoperative pain management in patients undergoing Modified Radical Mastectomy (MRM). The two techniques under investigation are the Thoracic Interfascial Plane Block (TIPB) and the Erector Spinae Plane Block (ESPB). Both nerve blocks are administered to provide targeted pain relief by numbing specific nerves involved in the surgical area.

Methodology:

Participants will be randomly assigned to one of two groups to receive either TIPB or ESPB. The randomization will ensure unbiased distribution of participants across both groups. The nerve blocks will be administered preoperatively under ultrasound guidance to ensure accurate placement and effectiveness.

Assessments and Measurements:

Pain levels will be assessed using the Visual Analog Scale (VAS) at multiple time points postoperatively, including at rest and during movement. The primary outcome measure is the total amount of rescue pain medication required within the first 48 hours after surgery. Secondary outcomes include the time to first rescue analgesic, intraoperative fentanyl consumption, hemodynamic parameters, sleep quality, time to first ambulation, VAS scores for pain and nausea, and overall patient satisfaction.

Safety and Monitoring:

Participants will be monitored for adverse events, including complications related to the nerve block techniques. Hemodynamic parameters, such as blood pressure and heart rate, will be closely observed during the perioperative period to ensure patient safety.

Significance:

The findings from this study aim to identify a superior pain management strategy that minimizes opioid consumption, reduces side effects, and enhances recovery and patient satisfaction following MRM. If successful, the results could inform clinical practice and improve postoperative care for breast cancer patients.

This study is conducted at Ain Shams University hospitals and adheres to ethical guidelines to ensure the safety and well-being of all participants.

Study Type

Interventional

Enrollment (Estimated)

50

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

Study Locations

  • Egypt
    • Abbasiya
      • Cairo, Abbasiya, Egypt, 1181
        • Recruiting
        • Ainshams university hospitals
        • Contact:
        • Principal Investigator:
          • Safie R Abd El Moneim, Masters degree

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:

  • Female patients older than 21 years old
  • American Society of Anesthesiologists (ASA) physical status II.

Exclusion Criteria:

  • Known allergy to one of the study's medications.
  • Skin infections at the site of the needle puncture.
  • Significant organ dysfunction (hepatic, renal, or cardiac dysfunction), coagulopathy or recent anticoagulant use, epilepsy.
  • Patients diagnosed with obstructive sleep apnoea, pulmonary compromise .

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thoracic Interfascial Plane Block
the Thoracic Interfascial Plane Block, which includes Pecto-Intercostal Fascial Plane Block and Serratus Intercostal Fascial Plane Block, is a peripheral nerve block that targets the intercostal nerve branches scattered throughout the chest and axilla
Procedure: Thoracic Interfascial Plane Block
The Thoracic Interfascial Plane Block (TIPB) is a regional anesthesia technique used to manage postoperative pain, particularly in thoracic and breast surgeries. This block involves the injection of a local anesthetic into the fascial plane between the thoracic muscles, targeting the nerves that supply the chest wall and upper abdominal area. It includes Pecto-Intercostal Fascial Plane Block (PIFB) and Serratus Intercostal Fascial Plane Block (SIFB).
Other Names:
  • Thoracic Nerve Block
  • TIPB
Active Comparator: Erector Spinae Plane Block
Erector Spinae Plane Block (ESPB) is an anesthesia technique for providing effective analgesia during and after breast and abdominal surgery
Procedure: Erector Spinae Plane Block
The Erector Spinae Plane Block (ESPB) is a regional anesthesia technique used to manage pain, particularly in thoracic and abdominal surgeries. This block involves the injection of a local anesthetic into the plane between the erector spinae muscle and the transverse processes of the vertebrae.
Other Names:
  • ESPB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total amount of rescue pain medication required within the first 48 hours after surgery
Time Frame: 48 hours
Researchers will report the total amount of analgesia used in the first 48 hours after surgery
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first rescue analgesia'
Time Frame: 48 hours
The time at which the first analgesia is adminstered after surgery
48 hours
Total intraoperative fentanyl consumption
Time Frame: Total intraoperative time of surgery
The total intraoperative consumption of fentanyl
Total intraoperative time of surgery
Sleep quality
Time Frame: 48 hours
The postoperative quality of sleep will be evaluated by The Pittsburgh Sleep Quality Index.
48 hours
Time for the first ambulation
Time Frame: 48 hours
The time at which the patient will be first be able to ambulate from bed.
48 hours
VAS score for pain
Time Frame: 48 hours
The postoperative pain using The Visual Analogue Scale (VAS) from 0 to 10, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could be).
48 hours
VAS score for nausea
Time Frame: 48 hours
nausea during the postoperative period using Visual Analogue Scale (VAS) with two endpoints representing 0 ('no nausea') and 10 ('nausea as bad as it could be')
48 hours
Patient Satisfaction score
Time Frame: 48 hours
(five-point Likert scale) where (1 = extremely dissatisfied to 5 = extremely satisfied) to measure postoperative patient satisfaction.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Safie ramez tewfeik abd el moneim

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

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)

November 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 15, 2025

Study Registration Dates

First Submitted

August 4, 2024

First Submitted That Met QC Criteria

August 8, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD178/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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