Regional Block for Postoperative Free Flap Care

Phase 4

Completed

• Conditions: Pain Management
• Interventions: Drug: ropivicaine 0.2%

• Registration Number: NCT04080739
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-09-04
• Study First Submitted QC: 2019-09-04
• Study First Posted: 2019-09-06
• Study Start: 2020-01-13
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-01
• Results First Submitted: 2023-06-03
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-27
• Last Update Submitted: 2023-11-27
• Results First Posted: 2023-12-06
• Last Update Posted: 2023-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	ropivicaine 0.2%	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.

Primary Outcome Measures

Name	Time	Method
Opioid Utilization Measured in Oral Morphine Equivalent (OME)	21 days	Opioid Utilization was measured by the number of mg of Oral Morphine Equivalent (oral pain medication) was given to patients.

Secondary Outcome Measures

Name	Time	Method
Opioid Medication Use	21 days	Amount of opioid medication used post-operatively

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States