Trial Outcomes & Findings for Study of the Efficacy of Local Analgesia as an Adjunct to General Anesthesia in Thyroidectomy and Parathyroidectomy (NCT NCT02205801)
NCT ID: NCT02205801
Last Updated: 2018-03-09
Results Overview
The total amount of Fentanyl administered during the procedure will be recorded.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
During the procedure
Results posted on
2018-03-09
Participant Flow
Participant milestones
| Measure |
Superficial Cervical Block, Active
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
|
Superficial Cervical Block, Placebo
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
|
Local Wound Infiltration, Active
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
|
Local Wound Infiltration, Placebo
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
8
|
9
|
8
|
|
Overall Study
COMPLETED
|
11
|
8
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Efficacy of Local Analgesia as an Adjunct to General Anesthesia in Thyroidectomy and Parathyroidectomy
Baseline characteristics by cohort
| Measure |
Superficial Cervical Block, Active
n=11 Participants
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
|
Superficial Cervical Block, Placebo
n=8 Participants
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
|
Local Wound Infiltration, Active
n=9 Participants
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
|
Local Wound Infiltration, Placebo
n=8 Participants
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
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
47.4 years
STANDARD_DEVIATION 15.5 • n=7 Participants
|
48.2 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
51.6 years
STANDARD_DEVIATION 15.3 • n=4 Participants
|
49.4 years
STANDARD_DEVIATION 13 • n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: During the procedureThe total amount of Fentanyl administered during the procedure will be recorded.
Outcome measures
| Measure |
Superficial Cervical Block, Active
n=11 Participants
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
|
Superficial Cervical Block, Placebo
n=8 Participants
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
|
Local Wound Infiltration, Active
n=9 Participants
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
|
Local Wound Infiltration, Placebo
n=8 Participants
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
|
|---|---|---|---|---|
|
Intraoperative Fentanyl Administration
|
187.5 mcg
Standard Deviation 89.2
|
185.7 mcg
Standard Deviation 80.2
|
144.2 mcg
Standard Deviation 65.0
|
156.3 mcg
Standard Deviation 43.8
|
SECONDARY outcome
Timeframe: At four hour after operationPain 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).
Outcome measures
| Measure |
Superficial Cervical Block, Active
n=11 Participants
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
|
Superficial Cervical Block, Placebo
n=8 Participants
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
|
Local Wound Infiltration, Active
n=9 Participants
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
|
Local Wound Infiltration, Placebo
n=8 Participants
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
|
|---|---|---|---|---|
|
Post Operative Pain
Incision
|
3 units on a scale
Standard Deviation 2.6
|
2.8 units on a scale
Standard Deviation 1.6
|
4.4 units on a scale
Standard Deviation 2.9
|
2.9 units on a scale
Standard Deviation 2
|
|
Post Operative Pain
Back of neck
|
1.4 units on a scale
Standard Deviation 1.3
|
3.4 units on a scale
Standard Deviation 3.4
|
2.3 units on a scale
Standard Deviation 2.1
|
2.4 units on a scale
Standard Deviation 2.0
|
|
Post Operative Pain
Throat
|
4.3 units on a scale
Standard Deviation 1.6
|
5.3 units on a scale
Standard Deviation 2.3
|
6.4 units on a scale
Standard Deviation 1.9
|
3.9 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: At 2 weeks after operationNausea 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").
Outcome measures
| Measure |
Superficial Cervical Block, Active
n=11 Participants
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
|
Superficial Cervical Block, Placebo
n=8 Participants
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
|
Local Wound Infiltration, Active
n=9 Participants
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
|
Local Wound Infiltration, Placebo
n=8 Participants
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
|
|---|---|---|---|---|
|
Post Operative Nausea Score
Incision
|
1.3 units on a scale
Standard Deviation 0.5
|
1.0 units on a scale
Standard Deviation 0
|
1.4 units on a scale
Standard Deviation 1.1
|
1.4 units on a scale
Standard Deviation 0.9
|
|
Post Operative Nausea Score
Back of neck
|
1.7 units on a scale
Standard Deviation 1.0
|
1.2 units on a scale
Standard Deviation 0.4
|
1.3 units on a scale
Standard Deviation 0.5
|
1.0 units on a scale
Standard Deviation 0
|
|
Post Operative Nausea Score
Throat
|
1.4 units on a scale
Standard Deviation 0.8
|
1.0 units on a scale
Standard Deviation 0
|
2.0 units on a scale
Standard Deviation 1.5
|
1.2 units on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: At follow up appointment 1-2 weeks postoperativelyTotal operative opioid dosages administered converted to effective mg of Hydromorphine.
Outcome measures
| Measure |
Superficial Cervical Block, Active
n=11 Participants
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
|
Superficial Cervical Block, Placebo
n=8 Participants
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
|
Local Wound Infiltration, Active
n=9 Participants
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
|
Local Wound Infiltration, Placebo
n=8 Participants
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 Pain Medication Utilization
|
0.56 mg
Standard Deviation 0.43
|
0.71 mg
Standard Deviation 0.4
|
0.84 mg
Standard Deviation 0.47
|
0.79 mg
Standard Deviation 0.52
|
Adverse Events
Superficial Cervical Block, Active
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Superficial Cervical Block, Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Local Wound Infiltration, Active
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Local Wound Infiltration, Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Raymond H. Grogan
The University of Chicago Medicine & Biological Sciences
Phone: 773-702-7125
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place