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

Not Applicable

Completed

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

• Registration Number: NCT02205801
• Lead Sponsor: University of Chicago

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-29
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-07-31
• Primary Completion: 2017-02-10
• Study Completion: 2017-02-17
• Results First Submitted: 2018-01-12
• Results First Submitted QC: 2018-01-12
• Status Verified: 2018-02
• Results First Posted: 2018-02-07
• Last Update Submitted: 2018-02-08
• Last Update Posted: 2018-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
superficial cervical block, active	Superficial Cervical Plexus Block	After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine.
superficial cervical block, active	Marcaine	After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine.
local wound infiltration, placebo	Local Wound Infiltration	After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline.
local wound infiltration, placebo	0.9% saline	After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline.
local wound infiltration, active	Local Wound Infiltration	After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine.
local wound infiltration, active	Marcaine	After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine.
superficial cervical block, placebo	Superficial Cervical Plexus Block	After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.
superficial cervical block, placebo	0.9% saline	After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.

Primary Outcome Measures

Name	Time	Method
Intraoperative Fentanyl Administration	During the procedure	The total amount of Fentanyl administered during the procedure will be recorded.

Secondary Outcome Measures

Name	Time	Method
Post Operative Nausea Score	At 2 weeks after operation	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").
Post Operative Pain	At four hour after operation	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).
Total Pain Medication Utilization	At follow up appointment 1-2 weeks postoperatively	Total operative opioid dosages administered converted to effective mg of Hydromorphine.

Trial Locations

Locations (1)

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States