Electrical Stimulation for Improving Postoperative Breast Sensation

NANot yet recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

September 1, 2024

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2026

Conditions
Mammaplasty
Interventions
DEVICE

Electrical Stimulation

Electrical stimulation - a needle attached to an cathode polarity will be placed within the intercostal space near the 4th intercostal nerve. A second needle attached to the anode polarity will be inserted into the serratus anterior muscle. Both electrodes will then be attached to a Grass SD9 stimulator and the voltage and frequency of the stimulation will be titrated to the point where contraction of the intercostal muscles is palpable. It will be maintained at this level for one hour at which point the wires will be removed. This technique is part of the standard of care for peripheral nerve surgeries of the extremities and is proven to be safe in humans.

PROCEDURE

Placebo

This breast will receive no electrical stimulation; the mastectomy and reconstruction will proceed with no intervention.

Trial Locations (2)

T5R2E1

University of Alberta Hospital, Edmonton

T5R4H5

Misericordia Hospital, Edmonton

All Listed Sponsors
lead

University of Alberta

OTHER

NCT03240900 - Electrical Stimulation for Improving Postoperative Breast Sensation | Biotech Hunter | Biotech Hunter