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

Not Applicable

Terminated

• Conditions: Post-operative Pain
• Interventions: Device: On-Q; Drug: Ultrasound guided pectoral nerve block

• Registration Number: NCT03201809
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2017-06-21
• Study First Submitted QC: 2017-06-26
• Study First Posted: 2017-06-28
• Primary Completion: 2020-03-23
• Study Completion: 2020-03-23
• Results First Submitted: 2021-07-08
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-14
• Last Update Submitted: 2021-10-14
• Results First Posted: 2021-10-15
• Last Update Posted: 2021-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
On-Q Catheter	On-Q	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).
Ultrasound Guided Pectoral Nerve Block	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

Name	Time	Method
Post-operative Narcotic Usage	post operation up to 2 days	amount of narcotic used

Secondary Outcome Measures

Name	Time	Method
Post-operative Anti-emetic Usage	post operation up to 2 days	number and amount of anti-emetic used
Post-operative Self-reported Pain Scores	post operation up to 2 days	Pain scores overall and by breast: 0 (no pain) - 100 (extreme pain) analog scale.

Trial Locations

Locations (1)

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States