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Serratus Anterior Plane Block in Patients Undergoing Mastectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03154658
Recruitment Status : Completed
First Posted : May 16, 2017
Results First Posted : February 24, 2021
Last Update Posted : March 16, 2021
Sponsor:
Information provided by (Responsible Party):
Anthony Machi, University of Texas Southwestern Medical Center

Brief Summary:
This is a randomized, interventional prospective study. Patients (n=66) undergoing mastectomies with or without tissue expander will be randomized to receive a supra-serratus or sub-serratus regional plane block prior to surgery. The main effect to be measured is total opioid consumption 24 hours after the operation. Secondary endpoints include measuring a change between pre-and post-operative pain scores, patient satisfaction of pain control during first 24 hours after the operation, presence of postoperative nausea and vomiting, duration of sleep on first postoperative night, and block performance time and length of stay, between the two treatment arms.

Condition or disease Intervention/treatment Phase
Pain, Post-operative Drug: Ropivacaine 0.35% Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized interventional prospective model to investigate effect of block placement in two treatment arms. Opioid consumption in the first 24 hours after the operation will be main outcome variable.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Serratus Anterior Plane Block: Sub-Serratus vs Supra-Serratus Plane Block for Pain Control in Patients Undergoing Mastectomy
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : March 1, 2020
Actual Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Arm Intervention/treatment
Experimental: Sub-serratus regional block
A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site deep to the serratus anterior muscle.
Drug: Ropivacaine 0.35%
The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.
Other Name: Ropivacaine

Active Comparator: Supra-serratus regional block
A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site superficial to the serratus anterior muscle.
Drug: Ropivacaine 0.35%
The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.
Other Name: Ropivacaine




Primary Outcome Measures :
  1. Opioid Consumption [ Time Frame: 24 hours post block ]
    Measures number of milligrams morphine equivalents each subject receives


Secondary Outcome Measures :
  1. Maximum Post-operative Pain Score [ Time Frame: 24 hours post block ]
    Measures the change in pain scores on a 0-10 Numeric Rating Scale where 0 is no pain and 10 is the maximum pain.

  2. Patient Satisfaction Scale [ Time Frame: 24 hours post block ]
    Pain satisfaction with regards to post-operative pain management within the first 24 hours post op on a 1-5 Likert scale of (1 poor, 2 fair, 3 good, 4 very good, 5 excellent).

  3. Number of Participants With Nausea/Vomiting [ Time Frame: 24 hours post block ]
    Measures the type and frequency of anti-emetics subjects receive

  4. Length of Stay [ Time Frame: 10 Days ]
    Measures total number of days subject is hospitalized, including day of surgery

  5. Sleep Duration Night of Postoperative Day 0 [ Time Frame: 24 hours post block ]
    Measures the total duration of sleep in minutes that subjects report sleeping on the night after surgery between postoperative days 0 and 1

  6. Block Performance Time [ Time Frame: Time from procedure needle insertion until needle removal, estimate less than 5 minutes ]
    Measures total time for block to take effect



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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:

  1. Adult patients 18 years or older
  2. Individuals undergoing either a mastectomy or mastectomy with tissue expander for which the anesthetic plan includes a serratus anterior plane block.

Exclusion Criteria:

  1. Any known sensory deficit of the anterolateral chest wall.
  2. Any local disorder of the skin or otherwise where blockade is to be performed which would prevent safe performance of the block
  3. Pregnancy
  4. American Society of Anesthesiology classification greater than 3
  5. Allergy to amide local anesthetic medications
  6. Chronic pain conditions
  7. Preoperative opioid use greater than 20 oral morphine equivalents per day
  8. Any coagulation abnormality which would be a contraindication for block placement
  9. Preoperative chronic renal dysfunction requiring renal replacement therapy or a serum creatinine greater than 1.4 mg/dL
  10. Body mass index >50
  11. Incarceration
  12. Inability to understand study procedures including inability to understand the English language
  13. Inability to provide adequate informed consent
  14. Refusal to participate in the study

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): NCT03154658


Locations
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United States, Texas
University of Texas Southwestern Medical Centers
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Anthony Machi, MD UT Southwestern Medical Center
  Study Documents (Full-Text)

Documents provided by Anthony Machi, University of Texas Southwestern Medical Center:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anthony Machi, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03154658    
Other Study ID Numbers: STU 122016-011
First Posted: May 16, 2017    Key Record Dates
Results First Posted: February 24, 2021
Last Update Posted: March 16, 2021
Last Verified: February 2021
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
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents