Goiter, Thyroid Neoplasm
Conditions
Keywords
Ropivacaine, Epinephrine, Endoscopy, Robotics, Thyroidectomy
Brief summary
To assess the pain relief and the hemodynamic stability of ropivacaine with epinephrine in BABA endoscopic and robotic thyroidectomy.
Detailed description
Diluted ropivacaine with epinephrine is injected into the subcutaneous space to relieve pain and reduce bleeding during procedures. The synergistic effect of ropivacaine with epinephrine can contribute to patients' welfare, such as relieving pain and structuring the hemodynamic stability.
Interventions
DRUGRopivacaine with epinephrine injection
1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection for the experiment group.
OTHERPlacebo
100cc normal saline is injected into the subcutaneous layer for the initial flap dissection for the placebo group.
Sponsors
Seoul National University Bundang Hospital
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Clinical diagnosis of thyroid neoplasm or benign goiter * Scheduled for BABA endoscopic or robotic thyroidectomy
Exclusion criteria
* Completion thyroidectomy * Modified radical neck dissection * Allergy history * Stroke history * Uncontrolled hypertension * Uncontrolled diabetes * Coagulopathy * Severe cardiovascular disease * Severe pulmonary disease * Chronic kidney disease * Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NRS Pain Scores for the First 12 Hours | Postoperative 12 hours | The numerical rating scale is utilized to assess the postoperative pain change for the first 12 hours according to location. Range: 0(minimal pain, better outcome) \ 10(maximum pain, worse outcome) Unlike the general NRS pain score as reported in the post-operative 48 hour result which deals with post-operative discomfort in general, this outcome measures the pain score of the specific location in which flap dissection had taken place. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum of Measured Diastolic Blood Pressures | participants were followed for the duration of the operation, an average of approximately 2.5 hours | The maximal diastolic blood pressure is monitored during surgery. |
| Maximum of Measured Heart Rates | participants were followed for the duration of the operation, an average of approximately 2.5 hours | The maximal heart rate is monitored during surgery. |
| Blood Loss Amount | participants were followed for the duration of the operation, an average of approximately 2.5 hours | The blood loss amount is estimated at the end of surgery. |
| Maximum of Measured Systolic Blood Pressures | participants were followed for the duration of the operation, an average of approximately 2.5 hours | The maximal systolic blood pressure is monitored during surgery. |
| NRS Change | 0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation | Change in NRS score a with time The numerical rating scale is utilized to assess the postoperative pain change for the first 12 hours according to location. Range: 0(minimal pain, better outcome) \ 10(maximum pain, worse outcome) |
| Pain Killer Dose | 0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation | Change in pain killer usage with time |
| Operation Time | participants were followed for the duration of the operation, an average of approximately 2.5 hours | The amount of time taken from start to the end of surgery |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Normal Saline Injection 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection. | 74 |
| Ropivacaine With Epinephrine Injection 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection. | 74 |
| Total | 148 |
Baseline characteristics
| Characteristic | Ropivacaine With Epinephrine Injection | Total | Normal Saline Injection |
|---|---|---|---|
| Age, Continuous | 35.5 years STANDARD_DEVIATION 8.8 | 36.1 years STANDARD_DEVIATION 9.7 | 38.0 years STANDARD_DEVIATION 9.3 |
| Extent of operation (Right/Left/Total) Left | 24 participants | 52 participants | 28 participants |
| Extent of operation (Right/Left/Total) Right | 29 participants | 55 participants | 26 participants |
| Extent of operation (Right/Left/Total) Total | 21 participants | 41 participants | 20 participants |
| Method of operation (robotic/endoscopic) Endoscopic | 19 participants | 40 participants | 21 participants |
| Method of operation (robotic/endoscopic) Robotic | 55 participants | 108 participants | 53 participants |
| Preoperative thyroid function test (free T4, ng/dL) | 1.2 ng/dL STANDARD_DEVIATION 0.4 | 1.2 ng/dL STANDARD_DEVIATION 0.4 | 1.2 ng/dL STANDARD_DEVIATION 0.3 |
| Preoperative thyroid function test (T3, ng/dL) | 123.3 ng/dL STANDARD_DEVIATION 25.1 | 122.5 ng/dL STANDARD_DEVIATION 20.6 | 121.8 ng/dL STANDARD_DEVIATION 15 |
| Preoperative thyroid function test (TSH, uIU/mL) | 2.2 uIU/mL STANDARD_DEVIATION 1.7 | 2.0 uIU/mL STANDARD_DEVIATION 1.4 | 1.8 uIU/mL STANDARD_DEVIATION 1 |
| Sex: Female, Male Female | 66 Participants | 135 Participants | 69 Participants |
| Sex: Female, Male Male | 8 Participants | 13 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 74 | 0 / 74 |
| serious Total, serious adverse events | 0 / 74 | 0 / 74 |
Outcome results
Primary
NRS Pain Scores for the First 12 Hours
The numerical rating scale is utilized to assess the postoperative pain change for the first 12 hours according to location. Range: 0(minimal pain, better outcome) \ 10(maximum pain, worse outcome) Unlike the general NRS pain score as reported in the post-operative 48 hour result which deals with post-operative discomfort in general, this outcome measures the pain score of the specific location in which flap dissection had taken place.
Time frame: Postoperative 12 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Normal Saline Injection | NRS Pain Scores for the First 12 Hours | Anterior neck pain | 4.50 points | Standard Deviation 2.1 |
| Normal Saline Injection | NRS Pain Scores for the First 12 Hours | Swallowing difficulty | 4.93 points | Standard Deviation 1.79 |
| Normal Saline Injection | NRS Pain Scores for the First 12 Hours | Back pain | 0.65 points | Standard Deviation 1.5 |
| Normal Saline Injection | NRS Pain Scores for the First 12 Hours | Right chest pain | 3.99 points | Standard Deviation 2.27 |
| Normal Saline Injection | NRS Pain Scores for the First 12 Hours | Posterior neck pain | 1.47 points | Standard Deviation 2.07 |
| Normal Saline Injection | NRS Pain Scores for the First 12 Hours | Left chest pain | 3.74 points | Standard Deviation 1.94 |
| Ropivacaine With Epinephrine Injection | NRS Pain Scores for the First 12 Hours | Posterior neck pain | 1.65 points | Standard Deviation 2.4 |
| Ropivacaine With Epinephrine Injection | NRS Pain Scores for the First 12 Hours | Swallowing difficulty | 4.12 points | Standard Deviation 1.87 |
| Ropivacaine With Epinephrine Injection | NRS Pain Scores for the First 12 Hours | Anterior neck pain | 3.69 points | Standard Deviation 1.94 |
| Ropivacaine With Epinephrine Injection | NRS Pain Scores for the First 12 Hours | Right chest pain | 3.16 points | Standard Deviation 1.96 |
| Ropivacaine With Epinephrine Injection | NRS Pain Scores for the First 12 Hours | Left chest pain | 4.51 points | Standard Deviation 2.45 |
| Ropivacaine With Epinephrine Injection | NRS Pain Scores for the First 12 Hours | Back pain | 0.28 points | Standard Deviation 1.05 |
Comparison: Swallowing difficultyp-value: 0.008t-test, 2 sided
Comparison: Anterior neck painp-value: 0.016t-test, 2 sided
Comparison: Right chest painp-value: 0.019t-test, 2 sided
Comparison: Left chest painp-value: 0.035t-test, 2 sided
Comparison: Back painp-value: 0.089t-test, 2 sided
Comparison: Posterior neck painp-value: 0.634t-test, 2 sided
Secondary
Blood Loss Amount
The blood loss amount is estimated at the end of surgery.
Time frame: participants were followed for the duration of the operation, an average of approximately 2.5 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Saline Injection | Blood Loss Amount | 30 ml | Standard Deviation 58.2 |
| Ropivacaine With Epinephrine Injection | Blood Loss Amount | 18 ml | Standard Deviation 40.5 |
Secondary
Maximum of Measured Diastolic Blood Pressures
The maximal diastolic blood pressure is monitored during surgery.
Time frame: participants were followed for the duration of the operation, an average of approximately 2.5 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Saline Injection | Maximum of Measured Diastolic Blood Pressures | 91 mmHg | Standard Deviation 14.9 |
| Ropivacaine With Epinephrine Injection | Maximum of Measured Diastolic Blood Pressures | 86 mmHg | Standard Deviation 19.2 |
Secondary
Maximum of Measured Heart Rates
The maximal heart rate is monitored during surgery.
Time frame: participants were followed for the duration of the operation, an average of approximately 2.5 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Saline Injection | Maximum of Measured Heart Rates | 88 beats per minute | Standard Deviation 16.1 |
| Ropivacaine With Epinephrine Injection | Maximum of Measured Heart Rates | 99 beats per minute | Standard Deviation 13.3 |
Secondary
Maximum of Measured Systolic Blood Pressures
The maximal systolic blood pressure is monitored during surgery.
Time frame: participants were followed for the duration of the operation, an average of approximately 2.5 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Saline Injection | Maximum of Measured Systolic Blood Pressures | 142 mmHg | Standard Deviation 16.5 |
| Ropivacaine With Epinephrine Injection | Maximum of Measured Systolic Blood Pressures | 145 mmHg | Standard Deviation 18.9 |
Secondary
NRS Change
Change in NRS score a with time The numerical rating scale is utilized to assess the postoperative pain change for the first 12 hours according to location. Range: 0(minimal pain, better outcome) \ 10(maximum pain, worse outcome)
Time frame: 0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Normal Saline Injection | NRS Change | 0 hour | 5.73 scores on a scale | Standard Deviation 2.02 |
| Normal Saline Injection | NRS Change | 12 hour | 3.19 scores on a scale | Standard Deviation 1.37 |
| Normal Saline Injection | NRS Change | 24 hour | 2.93 scores on a scale | Standard Deviation 1.09 |
| Normal Saline Injection | NRS Change | 48 hour | 2.27 scores on a scale | Standard Deviation 0.94 |
| Normal Saline Injection | NRS Change | 1 hour | 5.05 scores on a scale | Standard Deviation 1.95 |
| Normal Saline Injection | NRS Change | 2 hour | 4.55 scores on a scale | Standard Deviation 1.8 |
| Normal Saline Injection | NRS Change | 4 hour | 3.55 scores on a scale | Standard Deviation 1.27 |
| Normal Saline Injection | NRS Change | 6 hour | 3.39 scores on a scale | Standard Deviation 1.29 |
| Normal Saline Injection | NRS Change | 9 hour | 3.28 scores on a scale | Standard Deviation 1.34 |
| Ropivacaine With Epinephrine Injection | NRS Change | 6 hour | 3.28 scores on a scale | Standard Deviation 1.22 |
| Ropivacaine With Epinephrine Injection | NRS Change | 2 hour | 4.11 scores on a scale | Standard Deviation 1.56 |
| Ropivacaine With Epinephrine Injection | NRS Change | 12 hour | 3.18 scores on a scale | Standard Deviation 1.23 |
| Ropivacaine With Epinephrine Injection | NRS Change | 48 hour | 2.08 scores on a scale | Standard Deviation 0.9 |
| Ropivacaine With Epinephrine Injection | NRS Change | 24 hour | 2.95 scores on a scale | Standard Deviation 1.05 |
| Ropivacaine With Epinephrine Injection | NRS Change | 4 hour | 3.34 scores on a scale | Standard Deviation 1.19 |
| Ropivacaine With Epinephrine Injection | NRS Change | 0 hour | 5.68 scores on a scale | Standard Deviation 2.13 |
| Ropivacaine With Epinephrine Injection | NRS Change | 9 hour | 3.14 scores on a scale | Standard Deviation 1.38 |
| Ropivacaine With Epinephrine Injection | NRS Change | 1 hour | 4.7 scores on a scale | Standard Deviation 1.59 |
Secondary
Operation Time
The amount of time taken from start to the end of surgery
Time frame: participants were followed for the duration of the operation, an average of approximately 2.5 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Saline Injection | Operation Time | 163.6 minutes | Standard Deviation 54.1 |
| Ropivacaine With Epinephrine Injection | Operation Time | 155.3 minutes | Standard Deviation 46.8 |
Secondary
Pain Killer Dose
Change in pain killer usage with time
Time frame: 0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Normal Saline Injection | Pain Killer Dose | 1 hour | 0.35 vials (15mg ketorolac per vial) | Standard Deviation 0.51 |
| Normal Saline Injection | Pain Killer Dose | 9 hour | 0.14 vials (15mg ketorolac per vial) | Standard Deviation 0.34 |
| Normal Saline Injection | Pain Killer Dose | 4 hour | 0.07 vials (15mg ketorolac per vial) | Standard Deviation 0.25 |
| Normal Saline Injection | Pain Killer Dose | 12 hour | 0.18 vials (15mg ketorolac per vial) | Standard Deviation 0.42 |
| Normal Saline Injection | Pain Killer Dose | 2 hour | 0.31 vials (15mg ketorolac per vial) | Standard Deviation 0.49 |
| Normal Saline Injection | Pain Killer Dose | 24 hour | 0.20 vials (15mg ketorolac per vial) | Standard Deviation 0.44 |
| Normal Saline Injection | Pain Killer Dose | 6 hour | 0.18 vials (15mg ketorolac per vial) | Standard Deviation 0.38 |
| Normal Saline Injection | Pain Killer Dose | 48 hour | 0.01 vials (15mg ketorolac per vial) | Standard Deviation 0.11 |
| Normal Saline Injection | Pain Killer Dose | 0 hour | 1 vials (15mg ketorolac per vial) | Standard Deviation 0.72 |
| Ropivacaine With Epinephrine Injection | Pain Killer Dose | 48 hour | 0.07 vials (15mg ketorolac per vial) | Standard Deviation 0.15 |
| Ropivacaine With Epinephrine Injection | Pain Killer Dose | 0 hour | 0.84 vials (15mg ketorolac per vial) | Standard Deviation 0.6 |
| Ropivacaine With Epinephrine Injection | Pain Killer Dose | 1 hour | 0.31 vials (15mg ketorolac per vial) | Standard Deviation 0.47 |
| Ropivacaine With Epinephrine Injection | Pain Killer Dose | 2 hour | 0.26 vials (15mg ketorolac per vial) | Standard Deviation 0.44 |
| Ropivacaine With Epinephrine Injection | Pain Killer Dose | 4 hour | 0.11 vials (15mg ketorolac per vial) | Standard Deviation 0.31 |
| Ropivacaine With Epinephrine Injection | Pain Killer Dose | 6 hour | 0.15 vials (15mg ketorolac per vial) | Standard Deviation 0.36 |
| Ropivacaine With Epinephrine Injection | Pain Killer Dose | 9 hour | 0.12 vials (15mg ketorolac per vial) | Standard Deviation 0.33 |
| Ropivacaine With Epinephrine Injection | Pain Killer Dose | 12 hour | 0.19 vials (15mg ketorolac per vial) | Standard Deviation 0.43 |
| Ropivacaine With Epinephrine Injection | Pain Killer Dose | 24 hour | 0.16 vials (15mg ketorolac per vial) | Standard Deviation 0.41 |