Skip to content

Pectoral Nerve Block During Mastectomy

The Effect of Pectoral Nerve Block as a Part of Enhanced Recovery After Mastectomy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05699902
Acronym
PNB
Enrollment
40
Registered
2023-01-26
Start date
2023-04-01
Completion date
2024-12-30
Last updated
2023-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Female, Pain, Postoperative

Keywords

Breast cancer, Pain after mastectomy, PECs block

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.

Interventions

PROCEDUREPECs 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

PROCEDURESham block

Female undergone mastectomy and have received conventional analgesic methods

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Interventional

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
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. 2. Current or past medical history of liver disease or cirrhosis with an elevated INR \>1.4 or currently elevated transaminase levels. 3. known contraindications to peripheral nerve block placement. 4. Pregnant or breastfeeding. 5. History of allergic reactions attributed to compounds of similar chemical or biologic composition 6. 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).

Design outcomes

Primary

MeasureTime frameDescription
Post operative pain1yearPostoperative pain score at rest Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo).

Secondary

MeasureTime frameDescription
Patient's quality of life1 year1. Postoperative pain score on movement Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo) 2. Postoperative pain score at rest Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo).

Countries

Egypt

Contacts

Primary ContactKhaled Salah, Resident Dr
ksa53516@gmail.com+201030026633
Backup ContactMohamed Rizk, Lecturer
med.rizk٨٨@aun.edu.eg+201061988555

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026