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

NCT06548646 | Recruiting DMC

• 1 other identifier: MD178/2023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain Following Modified Radical Mastectomy for Breast Cancer

Keywords

breast cancer; Modified Radical Mastectomy; Mastectomy; postoperative pain; Erector Spinae Plane Block; Thoracic Interfascial Plane Block

Outcome Measures

Primary Outcomes (1)

• Total amount of rescue pain medication required within the first 48 hours after surgery

  Researchers will report the total amount of analgesia used in the first 48 hours after surgery

  48 hours

Secondary Outcomes (7)

• Time to first rescue analgesia'

  48 hours

• Total intraoperative fentanyl consumption

  Total intraoperative time of surgery

• Sleep quality

  48 hours

• Time for the first ambulation

  48 hours

• VAS score for pain

  48 hours

Study Arms (2)

Thoracic Interfascial Plane Block

EXPERIMENTAL

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

Erector Spinae Plane Block

ACTIVE COMPARATOR

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

Interventions

Thoracic Interfascial Plane Block PROCEDURE

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).

Also known as: Thoracic Nerve Block, TIPB

Thoracic Interfascial Plane Block

Erector Spinae Plane Block PROCEDURE

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.

Also known as: ESPB

Erector Spinae Plane Block

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Safie ramez tewfeik abd el moneim: lead

Study Sites (1)

Ainshams University Hospitals

Cairo, Abbasiya, 1181, Egypt

RECRUITING

Related Publications (5)

• Kaur U, Shamshery C, Agarwal A, Prakash N, Valiveru RC, Mishra P. Evaluation of postoperative pain in patients undergoing modified radical mastectomy with pectoralis or serratus-intercostal fascial plane blocks. Korean J Anesthesiol. 2020 Oct;73(5):425-433. doi: 10.4097/kja.20159. Epub 2020 Sep 24.

  PMID: 32987492 BACKGROUND

• Hong B, Yoon SH, Youn AM, Kim BJ, Song S, Yoon Y. Thoracic interfascial nerve block for breast surgery in a pregnant woman: a case report. Korean J Anesthesiol. 2017 Apr;70(2):209-212. doi: 10.4097/kjae.2017.70.2.209. Epub 2017 Jan 12.

  PMID: 28367293 BACKGROUND

• Zhang H, Miao Y, Qu Z. Refining a great idea: the consolidation of PECS I, PECS II and serratus blocks into a single thoracic fascial plane block, the SAP block-a concern on the muscle pain. Reg Anesth Pain Med. 2020 Jun;45(6):480. doi: 10.1136/rapm-2019-101042. Epub 2019 Oct 25. No abstract available.

  PMID: 31653798 BACKGROUND

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

  PMID: 2748771 BACKGROUND

• Boogaerts JG, Vanacker E, Seidel L, Albert A, Bardiau FM. Assessment of postoperative nausea using a visual analogue scale. Acta Anaesthesiol Scand. 2000 Apr;44(4):470-4. doi: 10.1034/j.1399-6576.2000.440420.x.

  PMID: 10757584 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Safie R Abd El Moneim, Masters

CONTACT

01280202299; safie.ramez@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 4, 2024
• First Posted: August 12, 2024
• Study Start: November 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 15, 2025
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)