Pectoral Nerve Block During Mastectomy (PNB)
The Effect of Pectoral Nerve Block as a Part of Enhanced Recovery After Mastectomy
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Khaled Salah, Resident Dr
- Phone Number: +2 +201030026633
- Email: ksa53516@gmail.com
Study Contact Backup
- Name: Mohamed Rizk, Lecturer
- Phone Number: +2 +201061988555
- Email: med.rizk٨٨@aun.edu.eg
Study Locations
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Assiut, Egypt
- Assiut University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: PECs block group
Female undergone mastectomy and received pectoral nerve block
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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
Other Names:
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Sham Comparator: Non PECs block group
Female undergone mastectomy and not received pectoral nerve block but have received conventional analgesic methods
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Female undergone mastectomy and have received conventional analgesic methods
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Post operative pain
Time Frame: 1year
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Postoperative pain score at rest Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo).
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1year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patient's quality of life
Time Frame: 1 year
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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mostafa Alaa eldin, Prof, Assiut University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pectoral nerve block in breast
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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