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

NCT ID: NCT03201809

Last Updated: 2021-10-15

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2020-03-23

Brief Summary

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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

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Conditions

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Post-operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups, conventional treatment versus experimental treatment; blocked randomization scheme
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

On-Q

Intervention Type DEVICE

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

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

Group Type ACTIVE_COMPARATOR

Ultrasound guided pectoral nerve block

Intervention Type DRUG

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

Interventions

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On-Q

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

Intervention Type DEVICE

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael S Wong, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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UC Davis Medical Center

Sacramento, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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918749

Identifier Type: -

Identifier Source: org_study_id