PNB: Pectoral Nerve Block During Mastectomy

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05699902
Collaborator
(none)
40
1
2
21
1.9

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: PECs block during mastectomy
  • Procedure: Sham block
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
InterventionalInterventional
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Pectoral Nerve Block as a Part of Enhanced Recovery After Mastectomy
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: PECs block group

Female undergone mastectomy and received pectoral nerve block

Procedure: PECs block during mastectomy
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:
  • PECs nerve injection
  • Sham Comparator: Non PECs block group

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

    Procedure: Sham block
    Female undergone mastectomy and have received conventional analgesic methods
    Other Names:
  • Non PECs block
  • Outcome Measures

    Primary Outcome Measures

    1. Post operative pain [1year]

      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

    1. Patient's quality of life [1 year]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1- all female planed for elective breast surgery

    Exclusion Criteria:
    1. 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.
    1. Current or past medical history of liver disease or cirrhosis with an elevated INR

    1.4 or currently elevated transaminase levels.

    1. known contraindications to peripheral nerve block placement.

    2. Pregnant or breastfeeding.

    3. History of allergic reactions attributed to compounds of similar chemical or biologic composition

    4. 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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut university Assiut Egypt

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Director: Mostafa Alaa eldin, Prof, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Khaled Salah Abd-Ellah, Assistant lecturer, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05699902
    Other Study ID Numbers:
    • Pectoral nerve block in breast
    First Posted:
    Jan 26, 2023
    Last Update Posted:
    Jan 26, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Khaled Salah Abd-Ellah, Assistant lecturer, Assiut University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 26, 2023