NCT04304716

Brief Summary

By utilizing regional anesthesia blocks at the surgery tissue donor sites, it can potentially reduce post-operative pain while also reducing the use of opioids. It can aim to measure the reduction in opioid use, reduction in pain scores, patient satisfaction, and because there is not a current protocol established for regional anesthesia use for free flap reconstruction, and we aim to standardize the procedure.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2020

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

March 9, 2020

Last Update Submit

March 17, 2020

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Opioid consumption

    Subjects' morphine equivalent dose. Postoperative period commences at extubation.

    72 hours (3 days) post-operatively

Study Arms (6)

Fibular free flap-Block performed

ACTIVE COMPARATOR

For subjects in the experimental/regional anesthesia group for anterolateral thigh or radial forearm free flap, during the procedure a catheter will be placed into the donor site (leg or arm), wound bed

Drug: Regional Anesthesia

Anterolateral thigh free flap-Block performed

ACTIVE COMPARATOR

Description: For subjects in the experimental/regional anesthesia group for anterolateral thigh or radial forearm free flap, during the procedure a catheter will be placed into the donor site (leg or arm), wound bed

Drug: Regional Anesthesia

Radial forearm free flap-Block performed

ACTIVE COMPARATOR

Description: For subjects in the experimental/regional anesthesia group for anterolateral thigh or radial forearm free flap, during the procedure a catheter will be placed into the donor site (leg or arm), wound bed

Drug: Regional Anesthesia

Fibular free flap -Control

NO INTERVENTION

No additional procedures beyond the normal standard of care will be performed

Anterolateral thigh free flap-Control

NO INTERVENTION

No additional procedures beyond the normal standard of care will be performed

Radial forearm free flap-Control

NO INTERVENTION

No additional procedures beyond the normal standard of care will be performed

Interventions

Regional AnesthesiaDRUG

Block performed is an indwelling wound bed or popliteal catheter placed intraoperatively

Anterolateral thigh free flap-Block performedFibular free flap-Block performedRadial forearm free flap-Block performed

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects undergoing microvascular fibula free flap reconstruction of the head and neck
  • Subjects undergoing primary reconstruction for both benign and malignant etiology

You may not qualify if:

  • Pregnant women
  • Subjects with true allergies to the study drugs, reporting anaphylaxis in the past
  • Subjects undergoing reconstruction with more than 1 free flap
  • Subjects undergoing secondary reconstructions
  • Subjects undergoing surgery for osteonecrosis
  • History of enrollment in a pain management program
  • Any subject currently enrolled in pain management, or currently taking long acting opioids such as methadone or oxycontin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Jacksonville, Florida, 32209, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Rui Fernandes, MD, DMD

    University of Florida

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2020

First Posted

March 11, 2020

Study Start

March 1, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

March 18, 2020

Record last verified: 2020-03

Locations

US(1)