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We aim to study the effect of local anesthetic when used in conjunction with general anesthesia during thyroidectomy or parathyroidectomy. We hypothesize there is equivalent pain control between bilateral superficial cervical plexus block and local wound infiltration when used in conjunction with a general anesthetic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| superficial cervical block, active | Active Comparator | After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine. |
|
| local wound infiltration, placebo | Placebo Comparator | After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline. |
|
| local wound infiltration, active | Active Comparator | After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine. |
|
| superficial cervical block, placebo | Placebo Comparator | After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Superficial Cervical Plexus Block | Procedure | 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Fentanyl Administration | The total amount of Fentanyl administered during the procedure will be recorded. | During the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative Pain | Pain scores will either be verbally reported to nursing and recorded or reported on a questionnaire. Back of neck pain scores range 0-10, throat pain scores range 0-9, incisional pain scores range 0-9 (zero means no pain and 9 or 10 means severe pain). | At four hour after operation |
| Post Operative Nausea Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymon Grogan, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Superficial Cervical Block, Active | After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine. Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy. Marcaine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 | Aug 8, 2014 |
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| Local Wound Infiltration | Procedure | 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy. |
|
| 0.9% saline | Drug |
|
| Marcaine | Drug |
|
Nausea scores will either be verbally reported to nursing and recorded or reported on a questionnaire. The scores range 0-9 (zero means no symptom and 9 means "very severe"). |
| At 2 weeks after operation |
| Total Pain Medication Utilization | Total operative opioid dosages administered converted to effective mg of Hydromorphine. | At follow up appointment 1-2 weeks postoperatively |
| FG001 | Superficial Cervical Block, Placebo | After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline. Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy. 0.9% saline |
| FG002 | Local Wound Infiltration, Active | After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine. Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy. Marcaine |
| FG003 | Local Wound Infiltration, Placebo | After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline. Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy. 0.9% saline |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Superficial Cervical Block, Active | After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine. Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy. Marcaine |
| BG001 | Superficial Cervical Block, Placebo | After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline. Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy. 0.9% saline |
| BG002 | Local Wound Infiltration, Active | After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine. Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy. Marcaine |
| BG003 | Local Wound Infiltration, Placebo | After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline. Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy. 0.9% saline |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Intraoperative Fentanyl Administration | The total amount of Fentanyl administered during the procedure will be recorded. | Posted | Mean | Standard Deviation | mcg | During the procedure |
|
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| Secondary | Post Operative Pain | Pain scores will either be verbally reported to nursing and recorded or reported on a questionnaire. Back of neck pain scores range 0-10, throat pain scores range 0-9, incisional pain scores range 0-9 (zero means no pain and 9 or 10 means severe pain). | Posted | Mean | Standard Deviation | units on a scale | At four hour after operation |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Post Operative Nausea Score | Nausea scores will either be verbally reported to nursing and recorded or reported on a questionnaire. The scores range 0-9 (zero means no symptom and 9 means "very severe"). | Posted | Mean | Standard Deviation | units on a scale | At 2 weeks after operation |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Total Pain Medication Utilization | Total operative opioid dosages administered converted to effective mg of Hydromorphine. | Posted | Mean | Standard Deviation | mg | At follow up appointment 1-2 weeks postoperatively |
|
8 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Superficial Cervical Block, Active | After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine. Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy. Marcaine | 0 | 11 | 0 | 11 | 0 | 11 |
| EG001 | Superficial Cervical Block, Placebo | After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline. Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy. 0.9% saline | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Local Wound Infiltration, Active | After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine. Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy. Marcaine | 0 | 9 | 0 | 9 | 0 | 9 |
| EG003 | Local Wound Infiltration, Placebo | After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline. Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy. 0.9% saline | 0 | 8 | 0 | 8 | 0 | 8 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Raymond H. Grogan | The University of Chicago Medicine & Biological Sciences | 773-702-7125 | rgrogan@surgery.bsd.uchicago.edu |
| Jan 12, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D006044 | Goiter, Nodular |
| D016606 | Thyroid Nodule |
| D006111 | Graves Disease |
| D006961 | Hyperparathyroidism |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D006042 | Goiter |
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
| D005128 | Eye Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010279 | Parathyroid Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| OG003 | Local Wound Infiltration, Placebo | After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline. Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy. 0.9% saline |
|
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| OG003 | Local Wound Infiltration, Placebo | After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline. Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy. 0.9% saline |
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| OG003 | Local Wound Infiltration, Placebo | After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline. Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy. 0.9% saline |
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