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

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.

Study Overview

• Status: Terminated
• Conditions: Post-operative Pain
• Intervention / Treatment: Device: On-Q; Drug: Ultrasound guided pectoral nerve block

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Narcotic Usage	amount of narcotic used	post operation up to 2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Anti-emetic Usage	number and amount of anti-emetic used	post operation up to 2 days
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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Michael S Wong, MD, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): March 23, 2020
• Study Completion (Actual): March 23, 2020

Study Registration Dates

• First Submitted: June 21, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 918749

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: available only as aggregate / HIPAA non-identifiable data in published papers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No