Pectoral Nerve Block During Mastectomy

NCT05699902 | Unknown DMC

• 1 other identifier: Pectoral nerve block in breast
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Impact of pectoral nerve block on postoperative pain and quality of recovery in patients undergoing breast cancer surgery: A prospective study

Conditions

Breast Cancer Female; Pain, Postoperative

Keywords

Breast cancer; Pain after mastectomy; PECs block

Outcome Measures

Primary Outcomes (1)

• Post operative pain

  Postoperative pain score at rest Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo).

  1year

Secondary Outcomes (1)

• Patient's quality of life

  1 year

Study Arms (2)

PECs block group

ACTIVE COMPARATOR

Female undergone mastectomy and received pectoral nerve block

Procedure: PECs block during mastectomy

Non PECs block group

SHAM COMPARATOR

Female undergone mastectomy and not received pectoral nerve block but have received conventional analgesic methods

Procedure: Sham block

Interventions

PECs block during mastectomy PROCEDURE

The patients were randomised to receive a PECS block consisting of 30 ml of levobupivacaine 0.25% after induction of anaesthesia (PECS group) or a saline mock block (control group). The patients answered a 40-item QoR questionnaire (QoR-40) before and 1 day after breast cancer surgery. MAIN OUTCOME MEASURES

Also known as: PECs nerve injection

PECs block group

Sham block PROCEDURE

Female undergone mastectomy and have received conventional analgesic methods

Also known as: Non PECs block

Non PECs block group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all female planed for elective breast surgery

You may not qualify if:

• Planned for bilateral axillary or bilateral reconstruction surgery.
• Previous surgery on the surgical breast and/or axilla with the exception of partial mastectomy or sentinel lymph node biopsy Pre-existing pain in the axilla affecting the ability to use extremity for activities of daily living or requiring medication for treatment.
• Current or past medical history of liver disease or cirrhosis with an elevated INR \>1.4 or currently elevated transaminase levels.
• known contraindications to peripheral nerve block placement.
• Pregnant or breastfeeding.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition
• Planned additional surgery to the surgical breast or axilla in the next year (exception would be minor surgery to breast but not axilla such as simple tissue expander replacement or lumpectomy).

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, Egypt

Location

Related Publications (3)

• Ueshima H, Otake H, Hara E, Blanco R. How to Use Pectoral Nerve Blocks Effectively-An Evidence-Based Update. Asian J Anesthesiol. 2019 Jun 1;57(2):28-36. doi: 10.6859/aja.201906_57(2).0002.

  PMID: 31382323 BACKGROUND

• Aarab Y, Ramin S, Odonnat T, Garnier O, Boissin A, Molinari N, Marin G, Perrigault PF, Cuvillon P, Chanques G. Pectoral Nerve Blocks for Breast Augmentation Surgery: A Randomized, Double-blind, Dual-centered Controlled Trial. Anesthesiology. 2021 Sep 1;135(3):442-453. doi: 10.1097/ALN.0000000000003855.

  PMID: 34195767 BACKGROUND

• Daniel Pereira D, Bleeker H, Malic C, Barrowman N, Shadrina A. Pectoral nerve block and acute pain management after breast reduction surgery in adolescent patients. Can J Anaesth. 2021 Oct;68(10):1574-1575. doi: 10.1007/s12630-021-02037-8. Epub 2021 Jun 3. No abstract available.

  PMID: 34081262 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Mostafa Alaa eldin, Prof

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Khaled Salah, Resident Dr

CONTACT

+201030026633; ksa53516@gmail.com

Mohamed Rizk, Lecturer

CONTACT

+201061988555; med.rizk٨٨@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: Interventional

Study Record Dates

• First Submitted: December 11, 2022
• First Posted: January 26, 2023
• Study Start: April 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 30, 2024
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year
• Access Criteria: Full access

Locations

EG (1)