Effect of Pectoralis Block on Analgesia After Simple Mastectomy

NCT03143530 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 160419
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Mastectomy; Nerve Block; Analgesia, Postoperative

Keywords

Ropivacaine

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Comparison of Numerical Rating Scale-11 (NRS-11) at rest

  90 days

• Comparison of Numerical Rating Scale-11 (NRS-11) with movement

  90 days

• Duration of postoperative analgesia

  Up to 24 hours

Study Arms (2)

Pectoralis Block with Ropivacaine

ACTIVE COMPARATOR

General anesthesia + pectoralis block with ropivacaine injection 30ml of 0.25% (75mg)

Procedure: Pectoralis block; Drug: Ropivacaine Injection

Pectoralis Block with normal saline

PLACEBO COMPARATOR

General anesthesia + Pectoralis block with 30ml of normal saline injection

Procedure: Pectoralis block; Drug: Normal saline injection

Interventions

Pectoralis block PROCEDURE

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).

Pectoralis Block with Ropivacaine; Pectoralis Block with normal saline

Normal saline injection DRUG

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

Pectoralis Block with normal saline

Ropivacaine Injection DRUG

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

Pectoralis Block with Ropivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Duke University: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Saline Solution; Ropivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Uma Shastri, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, investigators, and observers who record central measurements will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Model Details: Participants will be assigned to one of two of the following groups for the duration of the study. 1. General anesthesia + pectoralis block with Ropivacaine 30ml of 0.25% (75mg) 2. General anesthesia + sham block with 30ml of normal saline

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: May 8, 2017
• Study Start: December 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: April 1, 2019
• Last Updated: August 14, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)