NCT04080739

Brief Summary

The purpose of this protocol is to evaluate the safety and efficacy of regional anesthesia for head and neck patients undergoing microvascular free flap reconstruction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2020

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

January 13, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

December 6, 2023

Completed
Last Updated

December 6, 2023

Status Verified

November 1, 2023

Enrollment Period

2.1 years

First QC Date

September 4, 2019

Results QC Date

June 3, 2023

Last Update Submit

November 27, 2023

Conditions

Pain Management

Outcome Measures

Primary Outcomes (1)

  • Opioid Utilization Measured in Oral Morphine Equivalent (OME)

    Opioid Utilization was measured by the number of mg of Oral Morphine Equivalent (oral pain medication) was given to patients.

    21 days

Secondary Outcomes (1)

  • Opioid Medication Use

    21 days

Study Arms (2)

Experimental Group

EXPERIMENTAL

US-guided ipsilateral sciatic nerve block for fibula free flap patients utilizing ropivacaine 0.2% at 2-8 cc/hr for fibula free flap patients; US-guided infraclavicular brachial plexus nerve block for forearm free lap patients utilizing ropivacaine 0.2% at 2-8cc/hr for forearm free flap patients.

Drug: ropivicaine 0.2%

Control Group

NO INTERVENTION

No regional anesthetic of any kind during the surgical procedure.

Interventions

ropivicaine 0.2%DRUG

2-8 cc/hr of 0.2% ropivicaine given as a regional block via US-guided ipsilateral sciatic nerve block for fibula free flap patients or US-guided infraclavicular brachial plexus nerve block for forearm free flap patients.

Also known as: Naropin
Experimental Group

Eligibility Criteria

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

You may qualify if:

  • Age \> 18
  • Able to consent for themselves
  • Undergoing a head and neck surgery at UAB with reconstruction using either a forearm free flap or a fibula free flap

You may not qualify if:

  • Age \< 18
  • Unable to consent for themselves
  • Non-English speakers
  • Non-resectable tumor
  • Have a known opioid tolerance, or are on a home opioid regimen for a chronic condition. (Short-term opioid use for diagnostic procedures (i.e. biopsy) or new cancer diagnosis will be allowed).
  • Patients with known hepatic failure, renal failure, or sulfa allergy, as determined by standard of care labs drawn within 30 days of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

  • Le JM, Gigliotti J, Sayre KS, Morlandt AB, Ying YP. Supplemental Regional Block Anesthesia Reduces Opioid Utilization Following Free Flap Reconstruction of the Oral Cavity: A Prospective, Randomized Clinical Trial. J Oral Maxillofac Surg. 2023 Feb;81(2):140-149. doi: 10.1016/j.joms.2022.10.015. Epub 2022 Nov 1.

    PMID: 36442533BACKGROUND

Related Links

MeSH Terms

Conditions

Agnosia

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Dr. Anthony Morlandt
Organization
University of Alabama at Birmingham
morlandt@uab.edu
205-996-2799

Study Officials

  • Anthony Morlandt, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 4, 2019

First Posted

September 6, 2019

Study Start

January 13, 2020

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

December 6, 2023

Results First Posted

December 6, 2023

Record last verified: 2023-11

Locations

US(1)