Thyroid Neoplasms, Goiter, Nodular, Thyroid Nodule, Graves' Disease, Hyperparathyroidism
Conditions
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.
Interventions
PROCEDURESuperficial 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.
PROCEDURELocal 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.
DRUG0.9% saline
DRUGMarcaine
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Fentanyl Administration | During the procedure | The total amount of Fentanyl administered during the procedure will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
| Total Pain Medication Utilization | At follow up appointment 1-2 weeks postoperatively | Total operative opioid dosages administered converted to effective mg of Hydromorphine. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 11 |
| 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 | 8 |
| 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 | 9 |
| 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 | 8 |
| Total | 36 |
Baseline characteristics
| Characteristic | Local Wound Infiltration, Placebo | Total | Superficial Cervical Block, Active | Superficial Cervical Block, Placebo | Local Wound Infiltration, Active |
|---|---|---|---|---|---|
| Age, Continuous | 51.6 years STANDARD_DEVIATION 15.3 | 49.4 years STANDARD_DEVIATION 13 | 52 years STANDARD_DEVIATION 13.1 | 47.4 years STANDARD_DEVIATION 15.5 | 48.2 years STANDARD_DEVIATION 9.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 10 Participants | 4 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 25 Participants | 7 Participants | 6 Participants | 6 Participants |
| Sex: Female, Male Female | 4 Participants | 27 Participants | 9 Participants | 6 Participants | 8 Participants |
| Sex: Female, Male Male | 4 Participants | 9 Participants | 2 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 8 | 0 / 9 | 0 / 8 |
| other Total, other adverse events | 0 / 11 | 0 / 8 | 0 / 9 | 0 / 8 |
| serious Total, serious adverse events | 0 / 11 | 0 / 8 | 0 / 9 | 0 / 8 |
Outcome results
Primary
Intraoperative Fentanyl Administration
The total amount of Fentanyl administered during the procedure will be recorded.
Time frame: During the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Superficial Cervical Block, Active | Intraoperative Fentanyl Administration | 187.5 mcg | Standard Deviation 89.2 |
| Superficial Cervical Block, Placebo | Intraoperative Fentanyl Administration | 185.7 mcg | Standard Deviation 80.2 |
| Local Wound Infiltration, Active | Intraoperative Fentanyl Administration | 144.2 mcg | Standard Deviation 65 |
| Local Wound Infiltration, Placebo | Intraoperative Fentanyl Administration | 156.3 mcg | Standard Deviation 43.8 |
Secondary
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).
Time frame: At 2 weeks after operation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Superficial Cervical Block, Active | Post Operative Nausea Score | Throat | 1.4 units on a scale | Standard Deviation 0.8 |
| Superficial Cervical Block, Active | Post Operative Nausea Score | Incision | 1.3 units on a scale | Standard Deviation 0.5 |
| Superficial Cervical Block, Active | Post Operative Nausea Score | Back of neck | 1.7 units on a scale | Standard Deviation 1 |
| Superficial Cervical Block, Placebo | Post Operative Nausea Score | Back of neck | 1.2 units on a scale | Standard Deviation 0.4 |
| Superficial Cervical Block, Placebo | Post Operative Nausea Score | Incision | 1.0 units on a scale | Standard Deviation 0 |
| Superficial Cervical Block, Placebo | Post Operative Nausea Score | Throat | 1.0 units on a scale | Standard Deviation 0 |
| Local Wound Infiltration, Active | Post Operative Nausea Score | Throat | 2.0 units on a scale | Standard Deviation 1.5 |
| Local Wound Infiltration, Active | Post Operative Nausea Score | Incision | 1.4 units on a scale | Standard Deviation 1.1 |
| Local Wound Infiltration, Active | Post Operative Nausea Score | Back of neck | 1.3 units on a scale | Standard Deviation 0.5 |
| Local Wound Infiltration, Placebo | Post Operative Nausea Score | Back of neck | 1.0 units on a scale | Standard Deviation 0 |
| Local Wound Infiltration, Placebo | Post Operative Nausea Score | Incision | 1.4 units on a scale | Standard Deviation 0.9 |
| Local Wound Infiltration, Placebo | Post Operative Nausea Score | Throat | 1.2 units on a scale | Standard Deviation 0.4 |
Secondary
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).
Time frame: At four hour after operation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Superficial Cervical Block, Active | Post Operative Pain | Incision | 3 units on a scale | Standard Deviation 2.6 |
| Superficial Cervical Block, Active | Post Operative Pain | Throat | 4.3 units on a scale | Standard Deviation 1.6 |
| Superficial Cervical Block, Active | Post Operative Pain | Back of neck | 1.4 units on a scale | Standard Deviation 1.3 |
| Superficial Cervical Block, Placebo | Post Operative Pain | Incision | 2.8 units on a scale | Standard Deviation 1.6 |
| Superficial Cervical Block, Placebo | Post Operative Pain | Throat | 5.3 units on a scale | Standard Deviation 2.3 |
| Superficial Cervical Block, Placebo | Post Operative Pain | Back of neck | 3.4 units on a scale | Standard Deviation 3.4 |
| Local Wound Infiltration, Active | Post Operative Pain | Back of neck | 2.3 units on a scale | Standard Deviation 2.1 |
| Local Wound Infiltration, Active | Post Operative Pain | Incision | 4.4 units on a scale | Standard Deviation 2.9 |
| Local Wound Infiltration, Active | Post Operative Pain | Throat | 6.4 units on a scale | Standard Deviation 1.9 |
| Local Wound Infiltration, Placebo | Post Operative Pain | Incision | 2.9 units on a scale | Standard Deviation 2 |
| Local Wound Infiltration, Placebo | Post Operative Pain | Throat | 3.9 units on a scale | Standard Deviation 2.3 |
| Local Wound Infiltration, Placebo | Post Operative Pain | Back of neck | 2.4 units on a scale | Standard Deviation 2 |
Secondary
Total Pain Medication Utilization
Total operative opioid dosages administered converted to effective mg of Hydromorphine.
Time frame: At follow up appointment 1-2 weeks postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Superficial Cervical Block, Active | Total Pain Medication Utilization | 0.56 mg | Standard Deviation 0.43 |
| Superficial Cervical Block, Placebo | Total Pain Medication Utilization | 0.71 mg | Standard Deviation 0.4 |
| Local Wound Infiltration, Active | Total Pain Medication Utilization | 0.84 mg | Standard Deviation 0.47 |
| Local Wound Infiltration, Placebo | Total Pain Medication Utilization | 0.79 mg | Standard Deviation 0.52 |