Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control Group | No Intervention | No regional anesthetic of any kind during the surgical procedure. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Medication Use | Amount of opioid medication used post-operatively | 21 days |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anthony Morlandt, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36442533 | Background | 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. |
| Label | URL |
|---|---|
| Journal of Oral and Maxillofacial Surgery, Published November 1, 2022 | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control Group | No regional anesthetic of any kind during the surgical procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Subjects included | Posted | Mean | 95% Confidence Interval | mg | 21 days |
|
5 days post procedure
No adverse events were reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anthony Morlandt | University of Alabama at Birmingham | 205-996-2799 | morlandt@uab.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 3, 2023 | Jun 2, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 7, 2020 | Apr 25, 2023 | ICF_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| BG001 | Control Group | No regional anesthetic of any kind during the surgical procedure. |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | Control Group | No regional anesthetic of any kind during the surgical procedure. |
|
|
| Secondary | Opioid Medication Use | Amount of opioid medication used post-operatively | Posted | Mean | Standard Deviation | morphine milliequivalents | 21 days |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | Control Group | No regional anesthetic of any kind during the surgical procedure. | 0 | 50 | 0 | 50 | 0 | 50 |
Not provided
Not provided
Not provided
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |