Effect of Pectoralis Block on Analgesia After Simple Mastectomy

Study Overview
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Brief Summary
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The pectoralis block, including pecs I and II block, is a novel technique first described in 2011 as an alternative to paravertebral blockade for analgesia following breast surgery. The research goal is to determine the efficacy of the pectoralis block compared to placebo in improving quality of recovery following mastectomy.

Detailed Description
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The pectoralis block, including pecs I and II block, is a novel technique first described in 2011 as an alternative to paravertebral blockade for analgesia following breast surgery. The concept involves injecting local anesthetic near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior muscles (pecs II). This is a prospective, double-blinded, randomized controlled trial in subjects undergoing mastectomy under general anesthesia. The research goal is to determine the efficacy of the pectoralis block compared to placebo in improving quality of recovery following mastectomy.

Official Title
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The Effect of Pectoralis Block on Analgesia After Simple Mastectomy

Conditions
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Mastectomy, Nerve Block, Analgesia, Postoperative

Intervention / Treatment
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* Procedure: Pectoralis block
* Drug: Normal saline injection
* Drug: Ropivacaine Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA 1, 2, and 3 patients (According to ASA classification of comorbid conditions and general health) Patients undergoing simple mastectomy Exclusion Criteria: -Patient Refusal Allergy to local anesthetics Inability to communicate in English Use of 8 mg morphine equivalents or greater currently and for a period of longer then 2 weeks prior to surgery Existing nerve injuries or sensory deficits Conversion to anesthesia via an endotracheal tube

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Participants will be assigned to one of two of the following groups for the duration of the study. General anesthesia + pectoralis block with Ropivacaine 30ml of 0.25% (75mg) General anesthesia + sham block with 30ml of normal saline
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pectoralis Block with Ropivacaine<br>General anesthesia + pectoralis block with ropivacaine injection 30ml of 0.25% (75mg) | Procedure: Pectoralis block<br>* Pectoralis block involving injection near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior muscles (pecs II).<br>Drug: Ropivacaine Injection<br>* Pectoralis block involving injection of ropivacaine injection 30ml of 0,25% (75 mg) near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior<br>|
| Placebo Comparator: Pectoralis Block with normal saline<br>General anesthesia + Pectoralis block with 30ml of normal saline injection | Procedure: Pectoralis block<br>* Pectoralis block involving injection near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior muscles (pecs II).<br>Drug: Normal saline injection<br>* Pectoralis block involving injection of normal saline 30ml near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Recovery-27 score at baseline | Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery at baseline | Baseline | 
| Quality of Recovery-27 score at post operative day 1 | Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery, at baseline and post operative day 1 | Post operative day 1 | 
| Quality of Recovery-27 scores at post operative day 7 | Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery, at baseline and post operative day 7 | Post operative day 7 | 
| Quality of Recovery-27 scores at post operative day 30 | Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery, at baseline and post operative day 30 | Post operative day 30 | 
| Quality of Recovery-27 scores at post operative day 90 | Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery, at baseline and post operative day 90 | Post operative day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Numerical Rating Scale-11 (NRS-11) at rest | Comparison of patient reported pain assessment while at rest using the NRS-11 Scale at arrival in PACU, 15 minutes, 30 minutes, 1 hour and 2 hours after arrival in PACU, and postoperative days 1, 7, 30, and 90. The NRS-11 is a 11 point scale when 0 is no pain and 10 is severe pain. | 90 days | 
| Comparison of Numerical Rating Scale-11 (NRS-11) with movement | Comparison of patient reported pain assessment while with movement using the NRS-11 Scale at arrival in PACU, 15 minutes, 30 minutes, 1 hour and 2 hours after arrival in PACU, and postoperative days 1, 7, 30, and 90. The NRS-11 is a 11 point scale when 0 is no pain and 10 is severe pain. | 90 days | 
| Duration of postoperative analgesia | Duration of postoperative analgesia as measured by time in minutes to first intravenous or oral opioid postoperatively. | Up to 24 hours | 

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