Regional Block for Postoperative Free Flap Care

Pain Management Clinical Trial

Official title:

Regional Block for Postoperative Free Flap Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04080739
• Other study ID #: IRB-300003574
• Status: Completed
• Phase: Phase 4
• Start date: January 13, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: November 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The increasing rate of opioid related overdose mortality is well documented in the literature and approached 15 per 100,000 in 2017. Because of a growing epidemic in the US, the medical community is under scrutiny to curtail opioid prescription. However, this is weighed against surgical outcomes; importantly, postoperative pain has adverse effects on function, recovery and quality of life.

Regional anesthesia provides a non opioid based, pain control strategy. First, regional anesthesia decreases systemic adverse events including respiratory failure in abdominal surgery, decreases length of stay and improves rehabilitation in common orthopedic procedures such as total knee arthroplasty and shoulder arthroplasty. Second, the physiologic benefits of regional anesthesia are compelling including augmented micro and macrocirculation, maintenance of body temperature and decreased systemic stress response through chemical sympathectomy. Finally, regional anesthesia has been established as safe in the microvascular and anesthesia literature for pediatric, and adult patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• 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

Exclusion criteria:

• 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

Related Conditions & MeSH terms

• Pain Management

Intervention

Drug:
• ropivicaine 0.2%
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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Opioid Medication Use	Amount of opioid medication used post-operatively	21 days

External Links

•   Journal of Oral and Maxillofacial Surgery, Published November 1, 2022