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

NCT03201809 | Terminated Results FDA Device

• 1 other identifier: 918749
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Pain

Outcome Measures

Primary Outcomes (1)

• Post-operative Narcotic Usage

  amount of narcotic used

  post operation up to 2 days

Secondary Outcomes (2)

• Post-operative Anti-emetic Usage

  post operation up to 2 days

• Post-operative Self-reported Pain Scores

  post operation up to 2 days

Study Arms (2)

On-Q Catheter

EXPERIMENTAL

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

Ultrasound Guided Pectoral Nerve Block

ACTIVE COMPARATOR

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

Interventions

On-Q DEVICE

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

On-Q Catheter

Ultrasound guided pectoral nerve block 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

Ultrasound Guided Pectoral Nerve Block

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Limitations and Caveats

Due to 2 patients being lost to follow up and the small total number of subjects, the study findings were limited. Because of the nominal number of breast reconstruction patients at our institution meeting inclusion criteria for this trial, there was low enrollment.

Results Point of Contact

• Title: Dr. Granger Wong, Chief and Professor of Plastic Surgery
• Organization: UC Davis

gwong@ucdavis.edu

(916) 734-7289

Study Officials

• Michael S Wong, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups, conventional treatment versus experimental treatment; blocked randomization scheme

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: June 28, 2017
• Study Start: September 1, 2016
• Primary Completion: March 23, 2020
• Study Completion: March 23, 2020
• Last Updated: October 15, 2021
• Results First Posted: October 15, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)