Clinical trial NCT02205801
Conditions: Thyroid Neoplasms Goiter, Nodular Thyroid Nodule Graves' Disease Hyperparathyroidism
Sponsor: University of Chicago
Start date: 2014-07-01; Completion date: 2017-02-17
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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:

Arms: arm 1: After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine. arm 2: After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline. arm 3: After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine. arm 4: After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.
Interventions: intervention 1: Superficial Cervical Plexus Block intervention 2: Local Wound Infiltration intervention 3: 0.9% saline intervention 4: Marcaine
Intervention descriptions: intervention 1: 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 2: 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 3: None intervention 4: None

Protocol documents:
Prot_SAP_000.pdf: 
 
 
A Prospective Randomized Control Trial Comparing Preoperative Bilateral 
Superficial Cervical Plexus Block and Local Wound Infiltration Under General 
Anesthesia In Parathyroidectomy and Total and Partial Thyroidectomy 
 
Principal Investigtors: Raymon H. Grogan M.D., Peter Angelos M.D., Ph.D., Edwin L. 
Kaplan M.D. 
 
 
A. 
Study Abstract: 
Background: Administration of local anesthetic for cervical incisions has proven 
benefits in reduction of post-operative painiii, nausea, and vomitingiiiiv in 
prospective randomized controlled trials .  Methods of applying anesthetic to 
cervical incisions include bilateral superficial cervical plexus block (BSCPB) and 
local wound infiltration (LWI).  BSCPB involves the surgeon injecting 10 mL of 
0.25% Marcaine solution just lateral to the SCM at the level of the planned 
incision prior to the operation.  5 mL of the Marcaine solution are injected 
intradermaly while the remaining 5 mLs are injected 1 cm deep toward the 
planned incision.  This is then repeated on the contralateral side for a total 
injection of 20 mL of 0.25% Marcaine.  LWI involves injecting 20 mL of 0.25% 
marcaine solution intradermaly along the planned incision immediately prior to 
incision.  To date, there is no evidence suggesting one methodology’s superiority 
over the other.   
Methods: A prospective randomized control trial will be performed at our 
institution evaluating patients receiving either BSCPB or LWI with either 
anesthetic or placebo.  The primary aim of this study will be to evaluate intra 
operative pain medication utilization, post-operative pain as well as pain 
medication use at various intervals during recovery.  Secondary aims include 
post-operative nausea and vomiting, perioperative sequela of BSCPB and LWI, 
return to work, total pain medication utilization, site of pain, and return to driving 
will be evaluated at the first post-operative visit. 
 
 
1. 
Primary Hypothesis 
We hypothesize there is equivalent pain control between the two methods 
of local anesthetic administration when used in conjunction with a general 
anesthetic. 
 
 
2. 
Purpose of Proposed Protocol 
The primary goal of the proposed study is to compare outcomes in 
prospective controlled fashion between BSCPB and LWI.  The collected 
data will include post-operative pain scores, nausea scores, number of 
episodes of emesis, unanticipated overnight observation, unanticipated 
admission, total pain medication utilization, time to return to work, and 
time to return to driving. 
 


 
 
B. 
Prior Literature and Studies 
Numerous studies have examined various methods of local pain management in 
neck surgery.  To date the data comparing BSCPBi ii iii iv ix, LWIvviviiviii, and placebo 
remain equivocal.  A recent meta-analysis of eight RCTs examining BSCPB 
versus various controls found a small but variable benefit to BSCPB the authors 
felt was not clinically significantix.  With such heterogeneity present in the data, 
however, continued studies adding to the power of available data and examining 
further variable such as post-operative nausea vomiting should be performed.  
Only a single study exists studying the effect of local analgesia and intraoperative 
pain medication utilization in thyroidectomyx.  To our knowledge there are no 
RCTs comparing the efficacy of BSCPB to that of LWI. 
 
 
C. 
Study Objectives 
 
 
1. 
Primary Aim 
Compare intraoperative pain medication utilization between the four arms. 
 
2.  
Secondary Aim 
Compare serial post-operative pain scores during hospital recovery, post-
operative analgesic use, nausea scores, number of episodes of emesis, 
unanticipated overnight observation, unanticipated admission, total pain 
medication utilization, time to return to work, and time to return to driving 
in a prospective fashion. 
 
 
3. 
Rationale for Selection of Outcome Measures 
To date various studies have demonstrated variable results with local pain 
control therapies in conjunction with a general anesthetic.  If a benefit is 
demonstrated with either BSCPB or LWI it would suggest further study is 
warranted to determine an optimal pain control regimen for partial and 
total thyroidectomy procedures 
 
D. 
Investigational Intervention 
Patients evaluated in the outpatient offices and who are scheduled and 
consented for a parathyroidectomy or partial or total thyroidectomy will be 
approached for the study.  After consenting to participate the patient will undergo 
his/her scheduled procedure.  A research coordinator will be in charge of 
collecting demographic, clinical, and operative data.  Patients will have a form 
(see Appendix A) attached to their chart that will be completed by the 
anesthesiologist postoperatively and by PACU/floor nursing postoperatively.  In 
addition, a questionnaire will be provided to the patient at their first follow up visit 
and be collected by the research coordinator at that time. 
 
E. 
Study Design 


 
 
 
1.  
Overview 
This is a prospective randomized control trial examining post-operative 
pain, nausea, vomiting, return to activities of daily living.  The patients will 
be enrolled randomly into one of the  four arms of the study as follows:  
BSCPB with anesthetic (0.25% marcaine), BSCPB with placebo (saline), 
LWI with anesthetic (025% marcaine), and LWI with placebo.  BSCPB and 
LWI will be performed as described above.  The surgeon will be provided 
2 syringes of 10 mLs of either 0.9% normal saline or 0.25% Marcaine 
solution in the operating room labeled with only the patient’s name and 
study ID number to be correlated to saline or Marcaine by the research 
coordinator.  The anesthesiologist or nurse anesthetist providing 
anesthesia with standardized fentanyl and versed preoperatively (see 
appendix A), Fentanyl used at their discretion intraoperatively in 
conjunction with standardized inhalational anesthetic (Desflurane or 
Sevoflurane), and record the patient‘s medication requirements.  Patients 
will follow up as previously scheduled 1-2 weeks post operatively.  Clinical 
data from PACU and 24 hours observation stays will be accrued as well 
as a survey of post operative pain, nausea, and return to activities of daily 
living at the first follow up appointment. 
 
2. 
Subject Selection and Withdrawal 
 
 
a. 
Inclusion Criteria 
-Patient ≥ 18 years old 
-Surgical indication for parathyroidectomy or thyroidectomy (benign 
or malignant pathologies) 
 
 
b. 
Exclusion Criteria 
-Patients < 18 years old 
-Patient with history of chronic opioid use 
-Patient with chronic pain syndromes 
-Patient with allergy to marcaine, opioids, or inhalation anesthetic 
 
 
c. 
Ethical Considerations 
-All races, gender, and ethnicities of patients may be enrolled in this 
study 
 
 
d. 
Subject Recruitment Plans and Consent Process 
Patients who present with a disease process normally managed 
with the partial or total thyroidectomy will be presented with the 
study and given the choice of participation by the surgeon.  They 
will be informed of all aspects of the study procedure, risks and 
benefits, study schedule and requirements, including multiple 
questionnaires.  A written consent form will be provided.   Patients 
will be given considerable time to discuss the study with their family 
and to make their decision.  
 
 
e. 
Early Withdrawal of Subjects 
Subjects may withdraw from participation in the research protocol 
at any time 
 
3. 
Risks and Benefits 


 
 
 
 
a. 
Risks 
Risks associated with surgery for which they consented, no new 
risks associated with study protocol or procedure, patients in the 
placebo arms may be introduced to more intra- and post-operative 
pain from the cervical incision and therefore require increased 
narcotic.  This risk is easily assessed and treated with narcotic pain 
medication they will already be receiving. 
 
 
b. 
Benefits 
Benefits associated with surgery for which they consented, no new 
benefit associated with study protocol or procedure.  
 
 
F. 
Study Procedures 
 
1. 
Screening for Eligibility 
Attending surgeon will determine eligibility based on the above 
inclusion/exclusion criteria 
 
2. 
Measurements 
Age, sex, BMI, race, ethnicity, occupation, functional status 
Medical and surgical history 
History of post operative nausea/vomiting 
History of motion sickness 
Laboratory and imaging studies 
Diagnosis 
OR procedure time (from incision to closure) 
Technique 
EBL 
Total incision size in cm 
ASA class 
Intraoperative pain medication administration 
LOS from exit from OR until discharge time 
Pain medication administered in PACU and hospital 
Post-operative analgesic use 
Complications from surgical procedure 
Complications from performance of BSCPB and LWI  
Questionnaire 
 
Fatigue/Stamina 
 
Pain, 24 hour and 7 day versions 
 
Physical Function 
 
Patient Satisfaction 
           Bowel Function 
 
Return to work 
 
Return to driving 
 
Hoarseness 
 
Paresthesias 


 
 
 
3. 
Treatment Visits 
Visit 1: Preoperative Visit 
 
H & P 
 
Consent 
Visit 2: Surgery 
Visit 3: 1-2 week follow up 
 
Questionnaire 
 
4. 
Follow Up Visits 
Follow up visits will include medical history and physical examination, with 
particular attention to surgical complications, pain, post-operative nausea 
and vomiting, return to ADLs.  Patient reported outcome questionnaires 
will be included at these visits as described above. 
 
5. 
Safety and Adverse Events 
 
 
a. 
Safety and Compliance Monitoring 
 
 
b. 
Medical Monitoring 
 
 
c. 
Definitions of Adverse Events 
 
 
d. 
Data Collection and Procedures for Adverse Events 
 
 
e. 
Adverse Events Reports 
 
G. 
Data Handling and Record Keeping 
We recognize the importance for confidentiality of the patient’s protected health 
information (PHI).  PHI will be collected and transferred only where necessary.  
Patients will be identified only by generic ID’s.   
 
We require use of current passwords and log-on codes to protect sensitive data 
from unauthorized access. All system access requires a user name and 
password.  All users who require full access to the University of Chicago LAN 
must have a unique ID assigned. The LAN ID is used to control access to data 
files and applications that reside on the network. Every LAN ID is required to 
have a password assigned.  We require that all sensitive material be stored in a 
secure location when not in use. Study records will be maintained within the 
confines of the Surgical Research Office in locked cabinets.   
 
If study results are published, no personal information will be identified. 
 
 
Study records will be retained for at least 2 years following trial closure. 
 
H. 
Statistics and Data analysis 
 
Parametric outcomes such as patient demographics will be compared using 
analysis of variance and t-tests where appropriate.  Non-parametric outcomes 
such as intraoperative Fentanyl and post-operative pain scores will be compared 
using Kruskal-Wallis ANOVA.  All statistical analysis will be performed using 
STATA 15 (College Station, TX). 


 
 
 
Appendix A 
Thyroidectomy and Parathyroidectomy Anesthesia and PACU Protocol and Worksheet 
Operating Room 
 
Prior to intubation (standardized): 
Fentanyl: 0.5-1 mcg/kg (max 100mcg)    
  check to confirm Fentanyl given 
Versed: 1-2 mg    
 
 
 
 
  check to confirm Versed given 
 
Induction agent: 
Propofol: 1-3 mg/kg  
 
 
 
  check to confirm Propofol given 
 
Neuromuscular blockade (if required): 
 
Succinylcholine: 1-2 mg/kg  
 
 
  check if Succinylcholine given 
 
Intraoperative: 
Sevoflurane maintenance (no other volatile anesthetic) check to confirm 
 
 
Prior to incision:  
Baseline MAP ___________ 
Baseline HR ____________ 
 
Intraoperative Opioid: 
Fentanyl 0.5-2 mcg/kg (max 100 mcg) for MAP or HR > 20% deviation from baseline 
  
____________ Total fentanyl administered 
 
*if giving anti-emetic, please use Decadron (0.5mg/kg, max 10mg), check if given 
 
 
Please extubate patient awake 
 
 
____________ Time of intubation           ____________ Time of extubation 
--------------------------------------------------------------------------------------------------------------------- 
PACU 
Please only use Zofran for nausea and Dilaudid or Norco for pain 
 
 
4 Hours Post Operatively: 
 
 
 
Time_____________________________________________ 
 
 
 
Nausea score (1-10) ________________________________ 
 
 
 
Pain score (1-10): back of neck ___   throat ___  incision ____ 
 
 
 
Total Dilaudid administered in 4 hours ___________________ 
 
 
 
Total PO pain medicaitons administered in 4 hours_________ 
 


 
 
 
 
Anti-emetics administered (total) _______________________


 
 
Post Operative Check 
 
Post Operative Day #1: 
 
 
 
Time_____________________________________________ 
 
 
 
Nausea score (1-10) ________________________________ 
 
 
 
Pain score (1-10): back of neck ___   throat ___  incision ____ 
 
 
 
Total PO pain medications administered _________________ 
 
 
 
Anti-emetics administered (total) _______________________ 
 
 
 
 
http://karenswhimsy.com/public-domain-images/anatomy-of-the-neck/full/anatomy-of-the-neck-3.jpg 
 
Please score pain in the back of your throat or pain with swallowing from 1-10 
 
 
 
 


 
 
                                               
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