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Serratus Anterior Muscle Plane Block vsThoracic Paravertebral Block For Unilateral Mastectomies

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: NCT02822196
Recruitment Status : Withdrawn (Critical study personnel left the institution)
First Posted : July 4, 2016
Last Update Posted : September 16, 2020
Sponsor:
Collaborator:
Memorial Hermann Hospital
Information provided by (Responsible Party):
Sara R Guzman-Reyes, The University of Texas Health Science Center, Houston

Brief Summary:

HYPOTHESIS

Serratus Anterior Muscle Plane Block (SPB) is as effective as thoracic paravertebral block (PVB) for acute pain control after unilateral mastectomies.

SPECIFIC AIMS

Primary aim: To evaluate the efficacy of SPB block vs thoracic PVB for acute pain control in patients undergoing unilateral mastectomy

Secondary aim To compare the onset and duration of block and dermatomes blocked in both groups To compare the need of post-operative rescue analgesia in both groups. To compare the development of chronic incisional pain in both groups Functional outcome with respect to daily activities.


Condition or disease Intervention/treatment Phase
Breast Cancer Mastectomy Regional Anesthesia Post Operative Pain Drug: Lidocaine Drug: Bupivacaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Serratus Anterior Muscle Plane Block With Thoracic Paravertebral Block For Unilateral Mastectomies
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Arm Intervention/treatment
Experimental: Serratus Anterior Muscle Plane Block
The US probe will be placed in the mid-axillary line at the level of the 5th intercostal space. The latissimus dorsi, teres major and serratus muscles will be identified. Using in-plane approach, the block needle (22 G, 50 mm) will be inserted until the tip is visualized between the serratus anterior muscle and the intercostal muscles. As an extra reference point thoracodorsal artery will be used which aids in the identification of the plane superficial to the serratus muscle. After negative aspiration of blood, local anesthetic (20 ml of 0.25 % bupivacaine) will be injected and visualized in real-time.
Drug: Bupivacaine
Local Anesthesia using 0.25% Bupivacaine
Other Name: 0.25% Bupivacaine

Active Comparator: Thoracic Paravertebral Block
The spinous processes of T1- T5 will be identified and at parasagittal plan at 2.5 cm, skin wheel will be raised using 1% lidocaine. A 20-gauge, bevel needle will be advanced until the transverse process is located. The depth from skin to transverse process will be marked/identified by needle marking. The needle will be withdrawn 1-2 cm and angled down.The needle will be re-advanced 1cm past the initial marking. After negative aspiration, 4-5 ml of 0.25% bupivacaine will be slowly injected. The same procedure will be repeated at each level from T2 to T6 ensuring total dose of bupivacaine does not exceed the maximum dose recommended.
Drug: Lidocaine
Local Anesthesia using 1% Lidocaine
Other Name: 1% Lidocaine

Drug: Bupivacaine
Local Anesthesia using 0.25% Bupivacaine
Other Name: 0.25% Bupivacaine




Primary Outcome Measures :
  1. Efficacy of SPB block vs thoracic PVB [ Time Frame: 6 months ]
    Efficacy of SPB block vs thoracic PVB block as described by reduce post operative pain score and reduce requirement for Narcotics.


Secondary Outcome Measures :
  1. Onset and duration of block [ Time Frame: 6 months ]
    Onset and duration of block as described by the time when block performed to the time of onset of block and Dermatomal distribution of sensory loss (tested with ice)

  2. Post-operative rescue analgesia [ Time Frame: up to 24 hours ]
    Time for 1st rescue analgesia

  3. Development of chronic incisional pain [ Time Frame: 24 and 48 hours ]
    Total dose of rescue analgesia received during the first 24 and 48 hrs

  4. Pain related assessment scores as described in the Pain Detect Questionnaire [ Time Frame: 6 months ]
    Pain related assessment scores as described in the Pain Detect Questionnaire



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Simple or radical unilateral mastectomy with or without axillary lymph node dissection.
  • American Society of Anesthesia (ASA) I, II and III

Exclusion Criteria:

  • Morbid obesity (body mass index > 40 kg/m2);
  • Renal insufficiency (creatinine > 2.0 mg/DL),
  • Current chronic analgesic therapy (daily use > 4 weeks),
  • History of opioid dependence, pregnancy.
  • Allergy to local anesthetic
  • Rash/infection at the area of injection
  • Coagulation disorder
  • Patients on anticoagulation

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): NCT02822196


Locations
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United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Memorial Hermann Hospital
Investigators
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Principal Investigator: Sara Guzman-Reyes, MD The University of Texas Health Science Center, Houston
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Responsible Party: Sara R Guzman-Reyes, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02822196    
Other Study ID Numbers: HSC-MS-16-0467
First Posted: July 4, 2016    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
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
Lidocaine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action