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

• Sponsor: University of Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT02205801
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 4
• Actual Duration (Months): 31.6
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Neoplasms; Goiter, Nodular; Thyroid Nodule; Graves' Disease; Hyperparathyroidism	Procedure: Superficial Cervical Plexus Block; Procedure: Local Wound Infiltration; Drug: 0.9% saline; Drug: Marcaine	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: A Randomized Control Trial Comparing Bilateral Superficial Cervical Plexus Block and Local Wound Infiltration in Thyroidectomy and Parathyroidectomy
• Actual Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Feb 10, 2017
• Actual Study Completion Date: Feb 17, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: superficial cervical block, active After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine.	Procedure: 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.; Drug: Marcaine
Placebo Comparator: local wound infiltration, placebo After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline.	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.; Drug: 0.9% saline
Active Comparator: local wound infiltration, active After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine.	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.; Drug: Marcaine
Placebo Comparator: superficial cervical block, placebo After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.	Procedure: 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.; Drug: 0.9% saline

Outcome Measures

Primary Outcome Measures

1. Intraoperative Fentanyl Administration [During the procedure]

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

Secondary Outcome Measures

1. 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).

2. 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").

3. Total Pain Medication Utilization [At follow up appointment 1-2 weeks postoperatively]

   Total operative opioid dosages administered converted to effective mg of Hydromorphine.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago Medical Center	Chicago	Illinois	United States	60637

Sponsors and Collaborators

• University of Chicago

Investigators

• Principal Investigator: Raymon Grogan, MD, University of Chicago

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 8, 2014

More Information

Publications

None provided.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT02205801
• Other Study ID Numbers: IRB14-0374
• First Posted: Jul 31, 2014
• Last Update Posted: Mar 9, 2018
• Last Verified: Feb 1, 2018

• Additional relevant MeSH terms: Thyroid Nodule; Thyroid Neoplasms; Graves Disease; Thyroid Diseases; Hyperparathyroidism; Goiter, Nodular; Bupivacaine

Study Results

Participant Flow

Arm/Group Title	Superficial Cervical Block, Active	Superficial Cervical Block, Placebo	Local Wound Infiltration, Active	Local Wound Infiltration, Placebo
Arm/Group Description	After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine. 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. Marcaine	After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline. 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. 0.9% saline	After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine. 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. Marcaine	After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline. 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. 0.9% saline
Period Title: Overall Study
STARTED	11	8	9	8
COMPLETED	11	8	9	8
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Superficial Cervical Block, Active	Superficial Cervical Block, Placebo	Local Wound Infiltration, Active	Local Wound Infiltration, Placebo	Total
Arm/Group Description	After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine. 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. Marcaine	After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline. 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. 0.9% saline	After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine. 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. Marcaine	After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline. 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. 0.9% saline	Total of all reporting groups
Overall Participants	11	8	9	8	36
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52 (13.1)	47.4 (15.5)	48.2 (9.5)	51.6 (15.3)	49.4 (13)
Sex: Female, Male (Count of Participants)
Female	9 81.8%	6 75%	8 88.9%	4 50%	27 75%
Male	2 18.2%	2 25%	1 11.1%	4 50%	9 25%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	1 12.5%	0 0%	0 0%	1 2.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	4 36.4%	1 12.5%	3 33.3%	2 25%	10 27.8%
White	7 63.6%	6 75%	6 66.7%	6 75%	25 69.4%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Intraoperative Fentanyl Administration
Description	The total amount of Fentanyl administered during the procedure will be recorded.
Time Frame	During the procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Superficial Cervical Block, Active	Superficial Cervical Block, Placebo	Local Wound Infiltration, Active	Local Wound Infiltration, Placebo
Arm/Group Description	After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine. 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. Marcaine	After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline. 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. 0.9% saline	After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine. 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. Marcaine	After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline. 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. 0.9% saline
Measure Participants	11	8	9	8
Mean (Standard Deviation) [mcg]	187.5 (89.2)	185.7 (80.2)	144.2 (65.0)	156.3 (43.8)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Superficial Cervical Block, Active	Superficial Cervical Block, Placebo	Local Wound Infiltration, Active	Local Wound Infiltration, Placebo
Arm/Group Description	After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine. 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. Marcaine	After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline. 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. 0.9% saline	After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine. 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. Marcaine	After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline. 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. 0.9% saline
Measure Participants	11	8	9	8
Incision	3 (2.6)	2.8 (1.6)	4.4 (2.9)	2.9 (2)
Back of neck	1.4 (1.3)	3.4 (3.4)	2.3 (2.1)	2.4 (2.0)
Throat	4.3 (1.6)	5.3 (2.3)	6.4 (1.9)	3.9 (2.3)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Superficial Cervical Block, Active	Superficial Cervical Block, Placebo	Local Wound Infiltration, Active	Local Wound Infiltration, Placebo
Arm/Group Description	After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine. 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. Marcaine	After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline. 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. 0.9% saline	After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine. 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. Marcaine	After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline. 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. 0.9% saline
Measure Participants	11	8	9	8
Incision	1.3 (0.5)	1.0 (0)	1.4 (1.1)	1.4 (0.9)
Back of neck	1.7 (1.0)	1.2 (0.4)	1.3 (0.5)	1.0 (0)
Throat	1.4 (0.8)	1.0 (0)	2.0 (1.5)	1.2 (0.4)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Superficial Cervical Block, Active	Superficial Cervical Block, Placebo	Local Wound Infiltration, Active	Local Wound Infiltration, Placebo
Arm/Group Description	After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine. 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. Marcaine	After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline. 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. 0.9% saline	After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine. 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. Marcaine	After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline. 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. 0.9% saline
Measure Participants	11	8	9	8
Mean (Standard Deviation) [mg]	0.56 (0.43)	0.71 (0.4)	0.84 (0.47)	0.79 (0.52)

Adverse Events

Time Frame	8 months
Arm/Group Title	Superficial Cervical Block, Active		Superficial Cervical Block, Placebo		Local Wound Infiltration, Active		Local Wound Infiltration, Placebo
Arm/Group Description	After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine. 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. Marcaine		After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline. 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. 0.9% saline		After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine. 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. Marcaine		After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline. 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. 0.9% saline
All Cause Mortality
	Superficial Cervical Block, Active		Superficial Cervical Block, Placebo		Local Wound Infiltration, Active		Local Wound Infiltration, Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/8 (0%)		0/9 (0%)		0/8 (0%)
Serious Adverse Events
	Superficial Cervical Block, Active		Superficial Cervical Block, Placebo		Local Wound Infiltration, Active		Local Wound Infiltration, Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/8 (0%)		0/9 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Superficial Cervical Block, Active		Superficial Cervical Block, Placebo		Local Wound Infiltration, Active		Local Wound Infiltration, Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/8 (0%)		0/9 (0%)		0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.