The Analgesic Efficacy of the Pectoral Nerves Block Versus Local Anesthetic Infiltration After Mastectomy

Study Overview
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Brief Summary
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This trial will include patients undergoing radical mastectomy under general anesthesia. One group of patients will receive a pectoral nerve block, done by the anesthetist under ultrasound guidance at the beginning of the invervention. The other group will receive the a wound infiltration at the end of the intervention, done by the surgeon. Investigators will compare acute pain-related outcomes and chronic pain at 3 and 6 months postoperatively.

Detailed Description
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Mastectomies are associated with moderate to severe postoperative pain. In addition to general anesthesia, different methods of locoregional anesthesia exist to treat postoperative pain, amongst others a pectoral nerve block. This block consists in injecting local anesthetic between the muscles of the thoracic wall and is done under ultrasound guidance. Over the last few years, the pectoral nerves block has become a recognized option for the treatment of acute post-mastectomy pain and it is routinely performed in addition to general anesthesia. Data indicates that pectoral nerve blocks are effective for the treatment of postoperative pain during the first 24 hours after mastectomy, when compared to no block. However, the analgesic efficacy of a pectoral nerve block has never systematically compared to that of wound infiltration with local anesthetics, done by the surgeon at the end of the intervention. Such an infiltration is also currently employed. In our study randomize patients undergoing mastectomy under general anesthesia will be randomized to receive either an ultrasound-guided pectoral nerve block with 30 mL of local anesthetic (group PECS) or a wound infiltration with 30 mL of local anesthetic (group infiltration). Investigators will assess different pain-related outcomes over the first 24 postoperative hours, together with potential block-related side effects and patient satisfaction. Chronic postoperative pain at 3 and 6 months postoperatively will also be assessed. Both patients and outcome assessors will be blinded to group allocation.

Official Title
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The Analgesic Efficacy of the Pectoral Nerves Block Versus Local Anesthetic Infiltration After Mastectomy: a Randomized, Controlled, Double Blinded Trial

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: PECS block
* Other: Local infiltration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing unilateral mastectomy American Society of Anesthesiology Physical Status I-III Age ≥ 18 Exclusion Criteria: Contraindications to regional anesthesia, such as infection at the surgical site Pregnancy History of alcohol or drug dependence/abuse History of long term opioid intake Chronic pain disorder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PECS block<br>Ultrasound-guided pectoral nerve block with bupivacaine 0.5 % 30 mL before surgical incision | Other: PECS block<br>* Ultrasound-guided PECS block before surgical incision with 30 mL bupivacaine 0.5 %<br>|
| Active Comparator: Wound infiltration<br>Wound infiltration with bupivacaine 0.5 % 30 mL at the end of surgery | Other: Local infiltration<br>* Wound infiltration at the end of surgery with with 30 mL bupivacaine 0.5 %<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption | Cumulative intravenous morphine consumption (mg) | first 24 postoperative hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score at rest at 2 hours postoperatively | Numeric rating scale from 0 = no pain to 10 = worst imaginable pain | 2 hours postoperatively | 
| Pain score at rest at 12 hours postoperatively | Numeric rating scale from 0 = no pain to 10 = worst imaginable pain | 12 hours postoperatively | 
| Pain score at rest at 24 hours postoperatively | Numeric rating scale from 0 = no pain to 10 = worst imaginable pain | 24 hours postoperatively | 
| Pain score on movement at 2 hours postoperatively | Numeric rating scale from 0 = no pain to 10 = worst imaginable pain | 2 hours postoperatively | 
| Pain score on movement at 12 hours postoperatively | Numeric rating scale from 0 = no pain to 10 = worst imaginable pain | 12 hours postoperatively | 
| Pain score on movement at 24 hours postoperatively | Numeric rating scale from 0 = no pain to 10 = worst imaginable pain | 24 hours postoperatively | 
| Time to first analgesic request | Time between end of surgery and first analgesic request by patient, in minutes | 24 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mastectomy