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

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperparathyroidism; Thyroid Neoplasms; Goiter, Nodular; Thyroid Nodule; Graves' Disease
• Intervention / Treatment: Drug: Marcaine; Procedure: Superficial Cervical Plexus Block; Procedure: Local Wound Infiltration; Drug: 0.9% saline

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: superficial cervical block, active; After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine.	Drug: Marcaine; Procedure: 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.
Placebo Comparator: local wound infiltration, placebo; After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline.	Procedure: 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.; Drug: 0.9% saline
Active Comparator: local wound infiltration, active; After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine.	Drug: Marcaine; Procedure: 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.
Placebo Comparator: superficial cervical block, placebo; After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.	Procedure: 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.; Drug: 0.9% saline

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Raymon Grogan, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): February 10, 2017
• Study Completion (Actual): February 17, 2017

Study Registration Dates

• First Submitted: July 29, 2014
• First Submitted That Met QC Criteria: July 30, 2014
• First Posted (Estimate): July 31, 2014

Study Record Updates

• Last Update Posted (Actual): March 9, 2018
• Last Update Submitted That Met QC Criteria: February 8, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms; Autoimmune Diseases; Neoplasms by Site; Eye Diseases; Endocrine System Diseases; Endocrine Gland Neoplasms; Parathyroid Diseases; Head and Neck Neoplasms; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Hyperparathyroidism; Thyroid Diseases; Thyroid Neoplasms; Goiter, Nodular; Thyroid Nodule; Graves Disease; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: IRB14-0374