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Outcome Measures

Primary Outcomes (1)

Total Postoperative Opioid Use
To evaluate the impact of intraoperative methadone administration on postoperative opioid use and pain control in patients undergoing autologous breast reconstruction. Total perioperative opioid consumption will be measured in morphine milligram equivalents (MMEs), a standardized measure to quantify the strength of opioid doses compared to morphine. This outcome measure will be assessed from the day of surgery until discharge, up to 4 weeks.
from the day of surgery until discharge, up to 4 weeks.

Secondary Outcomes (9)

Patient-Reported Pain Scores - Visual Analog Scale
from the day of surgery until discharge, up to 4 weeks.
Patient-Reported Pain Scores - Pain Interference Score
from the day of surgery until discharge, up to 4 weeks.
Patient-Reported Pain Scores - Patient Pain Management Satisfaction Scale
from the day of surgery until discharge, up to 4 weeks.
Length of hospital stay
from the day of surgery until discharge, up to 4 weeks.
Proportion of participants utilizing non-opioid analgesics
from the day of surgery until discharge, up to 4 weeks.
+4 more secondary outcomes

Study Arms (2)

Intraoperative Methadone

EXPERIMENTAL

the methadone group will receive a single dose of intravenous methadone administered within 30 minutes after induction of anesthesia by the attending anesthesiologist. The standard dose will be 20 mg, except for patients under 60 kg or over 65 years of age, who will receive 15 mg.

Drug: Methadon

Control

NO INTERVENTION

The control group will not receive methadone and will instead receive a standard dose of 1 mg IV hydromorphone within the final 30-45 minutes of the procedure.

Interventions

MethadonDrug

A long-acting synthetic opioid with a pharmacologic profile that potentially offers more stable and longer-lasting pain relief.

Also known as: Diskets, Methadone Intensol, Methadose

Intraoperative Methadone

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Female patients 18 years of age or older
Patients undergoing unilateral or bilateral autologous breast reconstruction with abdominally-based free flaps after mastectomy for breast cancer or cancer prophylaxis

Related Publications (41)

CfDCa Prevention: Opioids. https://www.cdc.gov/opioids/index.html. Accessed October 26, 2021.

BACKGROUND

Hah JM, Bateman BT, Ratliff J, Curtin C, Sun E. Chronic Opioid Use After Surgery: Implications for Perioperative Management in the Face of the Opioid Epidemic. Anesth Analg. 2017 Nov;125(5):1733-1740. doi: 10.1213/ANE.0000000000002458.

PMID: 29049117BACKGROUND

Olds C, Spataro E, Li K, Kandathil C, Most SP. Assessment of Persistent and Prolonged Postoperative Opioid Use Among Patients Undergoing Plastic and Reconstructive Surgery. JAMA Facial Plast Surg. 2019 Jul 1;21(4):286-291. doi: 10.1001/jamafacial.2018.2035.

PMID: 30844024

Study Design

Study Type

interventional

Phase

phase 3

Allocation

RANDOMIZED

Masking

DOUBLE

Who Masked

PARTICIPANT, INVESTIGATOR

Masking Details

The anesthesiology provider assigned to the patient's surgery will be notified of which treatment arm the patient is assigned to by the research coordinator or by the Director of Anesthesia Services on the day of surgery. The reconstructive surgeon and all other hospital staff (e.g. nurses) will be blinded to what treatment arm the patient was assigned.

Purpose

SUPPORTIVE CARE

Intervention Model

PARALLEL

Sponsor Type

OTHER

Responsible Party

SPONSOR

Study Stopped

The Impact of Intraoperative Methadone on Postoperative Opioid Use

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (2)

Intraoperative Methadone

Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (41)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (2)

Intraoperative Methadone

Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (41)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations