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Pectoral Nerve Block During Mastectomy (PNB)

Primary Purpose

Breast Cancer Female, Pain, Postoperative

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
PECs block during mastectomy
Sham block
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Female focused on measuring Breast cancer, Pain after mastectomy, PECs block

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 1- all female planed for elective breast surgery Exclusion Criteria: 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).

Sites / Locations

  • Assiut university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

PECs block group

Non PECs block group

Arm Description

Female undergone mastectomy and received pectoral nerve block

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Patient's quality of life
Postoperative pain score on movement Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo) Postoperative pain score at rest Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo).

Full Information

First Posted
December 11, 2022
Last Updated
January 24, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05699902
Brief Title
Pectoral Nerve Block During Mastectomy
Acronym
PNB
Official Title
The Effect of Pectoral Nerve Block as a Part of Enhanced Recovery After Mastectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Impact of pectoral nerve block on postoperative pain and quality of recovery in patients undergoing breast cancer surgery: A prospective study
Detailed Description
Breast cancer is the most common malignancy in women; surgery is still the mainstay for the treatment of breast cancer . Postoperative pain can seriously reduce the quality of patient's life, and acute pain can even trigger chronic pain syndrome. Thoracic paravertebral, thoracic epidural, intercostal nerve, and interscalene brachial plexus blocks have been used for anesthesia and abirritation during mastectomy, but their applications are limited by the complicated technique of the procedures and several complications. In recent years, there has been increasing interest on a novel, less invasive technique, the pectoral nerve (PECS) block. Numerous clinical trials have focused on the analgesic potential of the pectoral nerve block in breast augmentation surgery, small breast surgery, and breast cancer surgery, and have shown positive results. Several prospective observational studies in recent years demonstrated that postoperative pain following breast surgery becomes chronic in up to 57% of women. One of the most important risk factors is insufficiently treated postoperative acute pain. The current gold standard for acute postoperative pain is a preventive procedure-specific multimodal treatment including nonopioids, opioids and regional analgesia. A recently published Cochran's meta-analysis demonstrated that regional analgesia [e.g. paravertebral block (PVB), local infiltration] might even reduce the risk of chronic postsurgical pain after breast surgery. According to a recently published guidelines, pectoral nerves (PECS) blocks seem to be an effective alternative to PVB to manage effectively postsurgical pain in major breast surgery.Anatomical studies revealed a different local anaesthetic spread following injections between the pectoralis major and minor muscles (PECS I) and a combination of the latter injection with a deeper injection between the pectoralis minor and serratus anterior muscles (PECS II) but the results were not conclusive. Many trials have been published and some meta-analyses revealed a high analgesic efficacy following PECS II blocks compared with no block or PVB. However, one of these meta-analyses was criticised because of methodological problems (e.g. evidence assessment, missing sham block group), pain intensities not analysed separately for resting pain and pain during movement and comparisons with other established or emerging regional anaesthetic techniques (e.g. local infiltration, erector spinae block) were not performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female, Pain, Postoperative
Keywords
Breast cancer, Pain after mastectomy, PECs block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Interventional
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PECs block group
Arm Type
Active Comparator
Arm Description
Female undergone mastectomy and received pectoral nerve block
Arm Title
Non PECs block group
Arm Type
Sham Comparator
Arm Description
Female undergone mastectomy and not received pectoral nerve block but have received conventional analgesic methods
Intervention Type
Procedure
Intervention Name(s)
PECs block during mastectomy
Other Intervention Name(s)
PECs nerve injection
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Sham block
Other Intervention Name(s)
Non PECs block
Intervention Description
Female undergone mastectomy and have received conventional analgesic methods
Primary Outcome Measure Information:
Title
Post operative pain
Description
Postoperative pain score at rest Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo).
Time Frame
1year
Secondary Outcome Measure Information:
Title
Patient's quality of life
Description
Postoperative pain score on movement Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo) Postoperative pain score at rest Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo).
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1- all female planed for elective breast surgery Exclusion Criteria: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Khaled Salah, Resident Dr
Phone
+201030026633
Ext
+2
Email
ksa53516@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Rizk, Lecturer
Phone
+201061988555
Ext
+2
Email
med.rizk٨٨@aun.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mostafa Alaa eldin, Prof
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Assiut university
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The study will be available when the targeted number of cases reached
IPD Sharing Time Frame
1 year
IPD Sharing Access Criteria
Full access
IPD Sharing URL
http://ksa53516@gmail.com
Citations:
PubMed Identifier
31382323
Citation
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.
Results Reference
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PubMed Identifier
34195767
Citation
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.
Results Reference
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PubMed Identifier
34081262
Citation
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.
Results Reference
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Pectoral Nerve Block During Mastectomy

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