Effect of Pectoralis Block on Analgesia After Simple Mastectomy

Phase 4

Withdrawn

• Conditions: Mastectomy; Nerve Block; Analgesia, Postoperative
• Interventions: Procedure: Pectoralis block; Drug: Ropivacaine Injection; Drug: Normal saline injection

• Registration Number: NCT03143530
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-08
• Study Start: 2017-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-10
• Last Update Posted: 2018-08-14
• Primary Completion: 2019-03-01
• Study Completion: 2019-04-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• ASA 1, 2, and 3 patients (According to ASA classification of comorbid conditions and general health)
• Patients undergoing simple mastectomy

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pectoralis Block with Ropivacaine	Pectoralis block	General anesthesia + pectoralis block with ropivacaine injection 30ml of 0.25% (75mg)
Pectoralis Block with Ropivacaine	Ropivacaine Injection	General anesthesia + pectoralis block with ropivacaine injection 30ml of 0.25% (75mg)
Pectoralis Block with normal saline	Pectoralis block	General anesthesia + Pectoralis block with 30ml of normal saline injection
Pectoralis Block with normal saline	Normal saline injection	General anesthesia + Pectoralis block with 30ml of normal saline injection

Primary Outcome Measures

Name	Time	Method
Quality of Recovery-27 score at baseline	Baseline	Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery at baseline
Quality of Recovery-27 score at post operative day 1	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
Quality of Recovery-27 scores at post operative day 7	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
Quality of Recovery-27 scores at post operative day 30	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
Quality of Recovery-27 scores at post operative day 90	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

Secondary Outcome Measures

Name	Time	Method
Comparison of Numerical Rating Scale-11 (NRS-11) at rest	90 days	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.
Comparison of Numerical Rating Scale-11 (NRS-11) with movement	90 days	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.
Duration of postoperative analgesia	Up to 24 hours	Duration of postoperative analgesia as measured by time in minutes to first intravenous or oral opioid postoperatively.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States