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NCT03201809 Clinical Trial

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

Post-operative Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03201809
Other study ID # 918749
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 1, 2016
Est. completion date March 23, 2020

Study information
Verified date October 2021
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 12
Est. completion date March 23, 2020
Est. primary completion date March 23, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• On-Q
0.2% Ropivicaine at 4 mL/h via On-Q catheter placed sub-pectoral
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

Locations
Country Name City State
United States UC Davis Medical Center Sacramento California

Sponsors (1)
Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Post-operative Narcotic Usage amount of narcotic used post operation up to 2 days
Secondary Post-operative Anti-emetic Usage number and amount of anti-emetic used post operation up to 2 days
Secondary Post-operative Self-reported Pain Scores Pain scores overall and by breast: 0 (no pain) - 100 (extreme pain) analog scale. post operation up to 2 days
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