Pectoral Nerve Block During Mastectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-12-30

Brief Summary

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Impact of pectoral nerve block on postoperative pain and quality of recovery in patients undergoing breast cancer surgery: A prospective study

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Detailed Description

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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.

Conditions

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Breast Cancer Female Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Interventional

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PECs block group

Female undergone mastectomy and received pectoral nerve block

Group Type ACTIVE_COMPARATOR

PECs block during mastectomy

Intervention Type PROCEDURE

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

Non PECs block group

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

Group Type SHAM_COMPARATOR

Sham block

Intervention Type PROCEDURE

Female undergone mastectomy and have received conventional analgesic methods

Interventions

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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

Intervention Type PROCEDURE

Sham block

Female undergone mastectomy and have received conventional analgesic methods

Intervention Type PROCEDURE

Other Intervention Names

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PECs nerve injection Non PECs block

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes