Effect of Pectoralis Block on Analgesia After Simple Mastectomy

The Effect of Pectoralis Block on Analgesia After Simple Mastectomy

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.

Study Overview

• Status: Withdrawn
• Conditions: Mastectomy; Nerve Block; Analgesia, Postoperative
• Intervention / Treatment: Procedure: Pectoralis block; Drug: Ropivacaine Injection; Drug: Normal saline injection

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pectoralis Block with Ropivacaine; General anesthesia + pectoralis block with ropivacaine injection 30ml of 0.25% (75mg)	Procedure: Pectoralis block; 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).; Drug: Ropivacaine Injection; 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
Placebo Comparator: Pectoralis Block with normal saline; General anesthesia + Pectoralis block with 30ml of normal saline injection	Procedure: Pectoralis block; 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).; Drug: Normal saline injection; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: Duke University
• Investigators: Principal Investigator: Uma Shastri, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2017
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: May 3, 2017
• First Posted (Actual): May 8, 2017

Study Record Updates

• Last Update Posted (Actual): August 14, 2018
• Last Update Submitted That Met QC Criteria: August 10, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Ropivacaine
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 160419

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No