Back to resultsStudy of the Efficacy of Local Analgesia as an Adjunct to General Anesthesia in Thyroidectomy and Parathyroidectomy
Primary Purpose
Thyroid Neoplasms, Goiter, Nodular, Thyroid Nodule
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Superficial Cervical Plexus Block
Local Wound Infiltration
0.9% saline
Marcaine
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Neoplasms
Eligibility Criteria
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
Sites / Locations
- University of Chicago Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Arm Label
superficial cervical block, active
local wound infiltration, placebo
local wound infiltration, active
superficial cervical block, placebo
Arm Description
After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine.
After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline.
After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine.
After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.
Outcomes
Primary Outcome Measures
Intraoperative Fentanyl Administration
The total amount of Fentanyl administered during the procedure will be recorded.
Secondary Outcome Measures
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).
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").
Total Pain Medication Utilization
Total operative opioid dosages administered converted to effective mg of Hydromorphine.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02205801
Brief Title
Study of the Efficacy of Local Analgesia as an Adjunct to General Anesthesia in Thyroidectomy and Parathyroidectomy
Official Title
A Randomized Control Trial Comparing Bilateral Superficial Cervical Plexus Block and Local Wound Infiltration in Thyroidectomy and Parathyroidectomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
February 10, 2017 (Actual)
Study Completion Date
February 17, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Neoplasms, Goiter, Nodular, Thyroid Nodule, Graves' Disease, Hyperparathyroidism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
superficial cervical block, active
Arm Type
Active Comparator
Arm Description
After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine.
Arm Title
local wound infiltration, placebo
Arm Type
Placebo Comparator
Arm Description
After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline.
Arm Title
local wound infiltration, active
Arm Type
Active Comparator
Arm Description
After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine.
Arm Title
superficial cervical block, placebo
Arm Type
Placebo Comparator
Arm Description
After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.
Intervention Type
Procedure
Intervention Name(s)
Superficial Cervical Plexus Block
Intervention Description
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
Intervention Name(s)
Local Wound Infiltration
Intervention Description
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
Drug
Intervention Name(s)
0.9% saline
Intervention Type
Drug
Intervention Name(s)
Marcaine
Primary Outcome Measure Information:
Title
Intraoperative Fentanyl Administration
Description
The total amount of Fentanyl administered during the procedure will be recorded.
Time Frame
During the procedure
Secondary Outcome Measure Information:
Title
Post Operative Pain
Description
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).
Time Frame
At four hour after operation
Title
Post Operative Nausea Score
Description
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").
Time Frame
At 2 weeks after operation
Title
Total Pain Medication Utilization
Description
Total operative opioid dosages administered converted to effective mg of Hydromorphine.
Time Frame
At follow up appointment 1-2 weeks postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymon Grogan, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of the Efficacy of Local Analgesia as an Adjunct to General Anesthesia in Thyroidectomy and Parathyroidectomy
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