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

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

NCT ID: NCT06548646

Condition: Postoperative Pain Following Modified Radical Mastectomy for Breast Cancer

Conditions: Official terms:
Pain, Postoperative

Conditions: Keywords:
breast cancer
Modified Radical Mastectomy
Mastectomy
postoperative pain
Erector Spinae Plane Block
Thoracic Interfascial Plane Block

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Masking description: All clinical staff, including surgeons, and anesthetists except the one giving the block, nurses, investigators, and patients will be blinded to the treatment group assignment

Intervention:

Intervention type: Procedure
Intervention name: Thoracic Interfascial Plane Block
Description: 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).
Arm group label: Thoracic Interfascial Plane Block

Other name: Thoracic Nerve Block

Other name: TIPB

Intervention type: Procedure
Intervention name: Erector Spinae Plane Block
Description: 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.
Arm group label: Erector Spinae Plane Block

Other name: ESPB

Summary: 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.

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.

Criteria for eligibility:
Criteria:
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 .

Gender: Female

Minimum age: 21 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Ainshams University Hospitals

Address:
City: Cairo
Zip: 1181
Country: Egypt

Contact:
Last name: Fatma Dr, Lecturer

Phone: 26857539

Phone ext: (202)
Email: rec-fmasu@med.asu.edu.eg

Investigator:
Last name: Safie R Abd El Moneim, Masters degree
Email: Principal Investigator

Start date: September 1, 2024

Completion date: March 15, 2025

Lead sponsor:
Agency: Safie ramez tewfeik abd el moneim
Agency class: Other

Source: Ain Shams University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06548646