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

NCT02205801 | Completed Results DMC

• 1 other identifier: IRB14-0374
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Intraoperative Fentanyl Administration

  The total amount of Fentanyl administered during the procedure will be recorded.

  During the procedure

Secondary Outcomes (3)

• Post Operative Pain

  At four hour after operation

• Post Operative Nausea Score

  At 2 weeks after operation

• Total Pain Medication Utilization

  At follow up appointment 1-2 weeks postoperatively

Study Arms (4)

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.

Procedure: Superficial Cervical Plexus Block; Drug: Marcaine

local wound infiltration, placebo

PLACEBO COMPARATOR

After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline.

Procedure: Local Wound Infiltration; Drug: 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.

Procedure: Local Wound Infiltration; Drug: 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.

Procedure: Superficial Cervical Plexus Block; Drug: 0.9% saline

Interventions

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.

superficial cervical block, active; superficial cervical block, placebo

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.

local wound infiltration, active; local wound infiltration, placebo

0.9% saline DRUG

local wound infiltration, placebo; superficial cervical block, placebo

Marcaine DRUG

local wound infiltration, active; superficial cervical block, active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient ≥ 18 years old
• Surgical indication for parathyroidectomy or thyroidectomy

You may not qualify if:

• Patients \< 18 years old
• Patient with history of chronic opioid use
• Patient with chronic pain syndromes
• Patient with allergy to marcaine

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Thyroid Neoplasms; Goiter, Nodular; Thyroid Nodule; Graves Disease; Hyperparathyroidism

Interventions

Saline Solution; Bupivacaine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Goiter; Exophthalmos; Orbital Diseases; Eye Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases; Parathyroid Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Raymond H. Grogan
• Organization: The University of Chicago Medicine & Biological Sciences

rgrogan@surgery.bsd.uchicago.edu

773-702-7125

Study Officials

• Raymon Grogan, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: July 31, 2014
• Study Start: July 1, 2014
• Primary Completion: February 10, 2017
• Study Completion: February 17, 2017
• Last Updated: March 9, 2018
• Results First Posted: February 7, 2018

Record last verified: 2018-02

Locations

US (1)