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

NCT ID: NCT02205801

Last Updated: 2018-03-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-02-17

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.

Detailed Description

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Conditions

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Thyroid Neoplasms Goiter, Nodular Thyroid Nodule Graves' Disease Hyperparathyroidism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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superficial cervical block, active

After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine.

Group Type ACTIVE_COMPARATOR

Superficial Cervical Plexus Block

Intervention Type 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.

Marcaine

Intervention Type DRUG

local wound infiltration, placebo

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

Group Type PLACEBO_COMPARATOR

Local Wound Infiltration

Intervention Type 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

Intervention Type DRUG

local wound infiltration, active

After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine.

Group Type ACTIVE_COMPARATOR

Local Wound Infiltration

Intervention Type 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.

Marcaine

Intervention Type DRUG

superficial cervical block, placebo

After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.

Group Type PLACEBO_COMPARATOR

Superficial Cervical Plexus Block

Intervention Type 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.

0.9% saline

Intervention Type DRUG

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

0.9% saline

Intervention Type DRUG

Marcaine

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raymon Grogan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB14-0374

Identifier Type: -

Identifier Source: org_study_id

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