Pain Management
Conditions
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.
Interventions
DRUGropivicaine 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.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Opioid Medication Use | 21 days | Amount of opioid medication used post-operatively |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental Group 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.
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. | 48 |
| Control Group No regional anesthetic of any kind during the surgical procedure. | 50 |
| Total | 98 |
Baseline characteristics
| Characteristic | Experimental Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants | 47 Participants | 91 Participants |
| Age, Continuous | 56 years | 56 years | 56 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 22 Participants | 22 Participants | 44 Participants |
| Sex: Female, Male Male | 26 Participants | 28 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 50 |
| other Total, other adverse events | 0 / 48 | 0 / 50 |
| serious Total, serious adverse events | 0 / 48 | 0 / 50 |
Outcome results
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.
Time frame: 21 days
Population: Subjects included
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Experimental Group | Opioid Utilization Measured in Oral Morphine Equivalent (OME) | 118 mg |
| Control Group | Opioid Utilization Measured in Oral Morphine Equivalent (OME) | 166 mg |
Secondary
Opioid Medication Use
Amount of opioid medication used post-operatively
Time frame: 21 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Opioid Medication Use | 118 morphine milliequivalents | Standard Deviation 98.6 |
| Control Group | Opioid Medication Use | 166 morphine milliequivalents | Standard Deviation 130.7 |