Study of the Efficacy of Local Analgesia as an Adjunct to General Anesthesia in Thyroidectomy and Parathyroidectomy

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Control Trial Comparing Bilateral Superficial Cervical Plexus Block and Local Wound Infiltration in Thyroidectomy and Parathyroidectomy

Conditions
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Thyroid Neoplasms, Goiter, Nodular, Thyroid Nodule, Graves' Disease, Hyperparathyroidism

Intervention / Treatment
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* Procedure: Superficial Cervical Plexus Block
* Procedure: Local Wound Infiltration
* Drug: 0.9% saline
* Drug: Marcaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient ≥ 18 years old Surgical indication for parathyroidectomy or thyroidectomy Exclusion Criteria: Patients < 18 years old Patient with history of chronic opioid use Patient with chronic pain syndromes Patient with allergy to marcaine

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: superficial cervical block, active<br>After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine. | Procedure: Superficial Cervical Plexus Block<br>* 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.<br>Drug: Marcaine<br> <br> |
| Placebo Comparator: local wound infiltration, placebo<br>After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline. | Procedure: Local Wound Infiltration<br>* 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.<br>Drug: 0.9% saline<br> <br> |
| Active Comparator: local wound infiltration, active<br>After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine. | Procedure: Local Wound Infiltration<br>* 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.<br>Drug: Marcaine<br> <br> |
| Placebo Comparator: superficial cervical block, placebo<br>After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline. | Procedure: Superficial Cervical Plexus Block<br>* 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.<br>Drug: 0.9% saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Fentanyl Administration | The total amount of Fentanyl administered during the procedure will be recorded. | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |