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Effect of Pectoralis Block on Analgesia After Simple Mastectomy

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ClinicalTrials.gov Identifier: NCT03143530
Recruitment Status : Withdrawn (Extensive protocol revisions initiated.)
First Posted : May 8, 2017
Last Update Posted : August 14, 2018
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Uma Shastri, 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.

Condition or disease Intervention/treatment Phase
Mastectomy Nerve Block Analgesia, Postoperative Procedure: Pectoralis block Drug: Normal saline injection Drug: Ropivacaine Injection Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Participants, care providers, investigators, and observers who record central measurements will be blinded to group allocation.
Primary Purpose: Treatment
Official Title: The Effect of Pectoralis Block on Analgesia After Simple Mastectomy
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Quality of Recovery-27 score at baseline [ Time Frame: Baseline ]
    Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery at baseline

  2. Quality of Recovery-27 score at post operative day 1 [ Time Frame: 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

  3. Quality of Recovery-27 scores at post operative day 7 [ Time Frame: 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

  4. Quality of Recovery-27 scores at post operative day 30 [ Time Frame: 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

  5. Quality of Recovery-27 scores at post operative day 90 [ Time Frame: 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 :
  1. Comparison of Numerical Rating Scale-11 (NRS-11) at rest [ Time Frame: 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.

  2. Comparison of Numerical Rating Scale-11 (NRS-11) with movement [ Time Frame: 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.

  3. Duration of postoperative analgesia [ Time Frame: Up to 24 hours ]
    Duration of postoperative analgesia as measured by time in minutes to first intravenous or oral opioid postoperatively.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03143530


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University Medical Center
Duke University
Investigators
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Principal Investigator: Uma Shastri, MD Vanderbilt University Medical Center
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Responsible Party: Uma Shastri, Assistant Professor of Anesthesiology, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03143530    
Other Study ID Numbers: 160419
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Uma Shastri, Vanderbilt University Medical Center:
Ropivacaine
Additional relevant MeSH terms:
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Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents