Pectoral Nerve Block During Mastectomy

Not Applicable

Not yet recruiting

• Conditions: Pain, Postoperative; Breast Cancer Female
• Interventions: Procedure: Sham block; Procedure: PECs block during mastectomy

• Registration Number: NCT05699902
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2022-12-11
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-24
• Last Update Submitted: 2023-01-24
• Study First Posted: 2023-01-26
• Last Update Posted: 2023-01-26
• Study Start: 2023-04-01
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non PECs block group	Sham block	Female undergone mastectomy and not received pectoral nerve block but have received conventional analgesic methods
PECs block group	PECs block during mastectomy	Female undergone mastectomy and received pectoral nerve block

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Patient's quality of life	1 year	1. 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).

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt