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

Thyroid Nodule Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02205801
• Other study ID #: IRB14-0374
• Status: Completed
• Phase: N/A
• First received: July 29, 2014
• Last updated: February 8, 2018
• Start date: July 2014
• Est. completion date: February 17, 2017

Study information

• Verified date: February 2018
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 17, 2017
• Est. primary completion date: February 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Goiter, Nodular
• Graves Disease
• Graves' Disease
• Hyperparathyroidism
• Thyroid Diseases
• Thyroid Neoplasms
• Thyroid Nodule

Intervention

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.
• 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

• Marcaine

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative Fentanyl Administration	The total amount of Fentanyl administered during the procedure will be recorded.	During the procedure
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).	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").	At 2 weeks after operation
Secondary	Total Pain Medication Utilization	Total operative opioid dosages administered converted to effective mg of Hydromorphine.	At follow up appointment 1-2 weeks postoperatively