Pectoral Nerve Block During Mastectomy

Trial Title: Pectoral Nerve Block During Mastectomy

NCT ID: NCT05699902

Condition: Breast Cancer Female
Pain, Postoperative

Conditions: Official terms:
Pain, Postoperative

Conditions: Keywords:
Breast cancer
Pain after mastectomy
PECs block

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Interventional

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Intervention:

Intervention type: Procedure
Intervention name: PECs block during mastectomy
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
Arm group label: PECs block group

Other name: PECs nerve injection

Intervention type: Procedure
Intervention name: Sham block
Description: Female undergone mastectomy and have received conventional analgesic methods
Arm group label: Non PECs block group

Other name: Non PECs block

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.

Criteria for eligibility:
Criteria:
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).

Gender: Female

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Assiut university

Address:
City: Assiut
Country: Egypt

Start date: April 1, 2023

Completion date: December 30, 2024

Lead sponsor:
Agency: Assiut University
Agency class: Other

Source: Assiut University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05699902