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Comparison of Preoperative Ultrasound Guided Pectoralis Nerve Block Placement Versus Intra-operative Placement: A Prospective Randomized Trial

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ClinicalTrials.gov Identifier: NCT03201809
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
This study investigates the use of post-operative on-Q pain catheters for tissue expander based breast reconstruction, versus conventional ultrasound-guided blocks placed pre-operatively.

Condition or disease Intervention/treatment Phase
Post-operative Pain Device: On-Q Drug: Ultrasound guided pectoral nerve block Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups, conventional treatment versus experimental treatment; blocked randomization scheme
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Preoperative Ultrasound Guided Pectoralis Nerve Block Placement Versus Intra-operative Placement: A Prospective Randomized Trial
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: On-Q Catheter
On-Q catheters placed within the implant pocket; infusion of 0.2% Ropivacaine at 4 mL/h for a total of 400 mL (about 4 days).
Device: On-Q
0.2% Ropivicaine at 4 mL/h via On-Q catheter placed sub-pectoral

Active Comparator: Ultrasound Guided Pectoral Nerve Block
Single Shot Pre-operative injections of 10 mL of 0.25% Ropivicaine for the Pecs 1 injection, and 20 mL of 0.25% Ropivacaine for the pecs 2 injection
Drug: Ultrasound guided pectoral nerve block
Single Shot Pre-operative injections of 10 mL of 0.25% Ropivicaine for the Pecs 1 injection, and 20 mL of 0.25% Ropivacaine for the Pecs 2 injection




Primary Outcome Measures :
  1. Post-operative Narcotic Usage [ Time Frame: post operation up to 7 days ]
    amount of narcotic used


Secondary Outcome Measures :
  1. Post-operative anti-emetic usage [ Time Frame: post operation up to 7 days ]
    number and amount of anti-emetic used

  2. Post-operative self-reported pain scores [ Time Frame: post operation up to 7 days ]
    pain scores overall and by breast 0-10 analog scale



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • presenting for breast reconstruction w/ planned two-stage, sub muscular tissue expander placement.

Exclusion Criteria:

  • pregnant, prisoners, cannot consent, history of chronic pain or pain medication use

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): NCT03201809


Contacts
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Contact: Kate M Hinchcliff, MD 6072293334 kmhinchcliff@ucdavis.edu

Locations
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United States, California
UC Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Kate M Hinchcliff, MD    607-229-3334    kmhinchcliff@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Michael S Wong, MD University of California, Davis

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03201809     History of Changes
Other Study ID Numbers: 918749
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: available only as aggregate / HIPAA non-identifiable data in published papers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: 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
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents