A Phase 3 interventional study of Ropivacaine with epinephrine injection and Placebo in Thyroid Neoplasm and Goiter, sponsored by Seoul National University Hospital. Completed at 2 sites in South Korea. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-04.
Sponsored by Seoul National University Hospital · Phase 3, Interventional, and Treatment
To assess the pain relief and the hemodynamic stability of ropivacaine with epinephrine in BABA endoscopic and robotic thyroidectomy.
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.
819 studies on the registry are indexed under Thyroid Neoplasms; 216 are open to participants now.
This study's enrollment of 148 is above the median of 50 across 518 interventional studies indexed under Thyroid Neoplasms.
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Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
Other: Placebo
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.
Drug: Ropivacaine with epinephrine injection
Drug pages: Ropivacaine · Epinephrine
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.
Also known as: Hanlim ropiva injection 7.5 mg/mL (20cc), Insurance code: A37804211, Jeil epinephrine injection 1 mg/mL (1cc), Insurance code: A04900341
100cc normal saline is injected into the subcutaneous layer for the initial flap dissection for the placebo group.
Also known as: CJ 0.9% Normal Saline injection 100cc, Insurance code: A11601752
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
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
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
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
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
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
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
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
| Milestone | Normal Saline Injection | Ropivacaine With Epinephrine Injection |
|---|---|---|
| Started | 74 | 74 |
| Completed | 74 | 74 |
| Not completed | 0 | 0 |
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.
| points | Normal Saline Injection | Ropivacaine With Epinephrine Injection |
|---|---|---|
| Swallowing difficulty | 4.93 ± 1.79 | 4.12 ± 1.87 |
| Anterior neck pain | 4.50 ± 2.10 | 3.69 ± 1.94 |
| Right chest pain | 3.99 ± 2.27 | 3.16 ± 1.96 |
| Left chest pain | 3.74 ± 1.94 | 4.51 ± 2.45 |
| Back pain | 0.65 ± 1.50 | 0.28 ± 1.05 |
| Posterior neck pain | 1.47 ± 2.07 | 1.65 ± 2.40 |
The maximal systolic blood pressure is monitored during surgery.
| mmHg | Normal Saline Injection | Ropivacaine With Epinephrine Injection |
|---|---|---|
| Maximum of Measured Systolic Blood Pressures | 142 ± 16.5 | 145 ± 18.9 |
The maximal diastolic blood pressure is monitored during surgery.
| mmHg | Normal Saline Injection | Ropivacaine With Epinephrine Injection |
|---|---|---|
| Maximum of Measured Diastolic Blood Pressures | 91 ± 14.9 | 86 ± 19.2 |
The maximal heart rate is monitored during surgery.
| beats per minute | Normal Saline Injection | Ropivacaine With Epinephrine Injection |
|---|---|---|
| Maximum of Measured Heart Rates | 88 ± 16.1 | 99 ± 13.3 |
The blood loss amount is estimated at the end of surgery.
| ml | Normal Saline Injection | Ropivacaine With Epinephrine Injection |
|---|---|---|
| Blood Loss Amount | 30 ± 58.2 | 18 ± 40.5 |
The amount of time taken from start to the end of surgery
| minutes | Normal Saline Injection | Ropivacaine With Epinephrine Injection |
|---|---|---|
| Operation Time | 163.6 ± 54.1 | 155.3 ± 46.8 |
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)
| scores on a scale | Normal Saline Injection | Ropivacaine With Epinephrine Injection |
|---|---|---|
| 0 hour | 5.73 ± 2.02 | 5.68 ± 2.13 |
| 1 hour | 5.05 ± 1.95 | 4.7 ± 1.59 |
| 2 hour | 4.55 ± 1.80 | 4.11 ± 1.56 |
| 4 hour | 3.55 ± 1.27 | 3.34 ± 1.19 |
| 6 hour | 3.39 ± 1.29 | 3.28 ± 1.22 |
| 9 hour | 3.28 ± 1.34 | 3.14 ± 1.38 |
| 12 hour | 3.19 ± 1.37 | 3.18 ± 1.23 |
| 24 hour | 2.93 ± 1.09 | 2.95 ± 1.05 |
| 48 hour | 2.27 ± 0.94 | 2.08 ± 0.90 |
Change in pain killer usage with time
| vials (15mg ketorolac per vial) | Normal Saline Injection | Ropivacaine With Epinephrine Injection |
|---|---|---|
| 0 hour | 1 ± 0.72 | 0.84 ± 0.60 |
| 1 hour | 0.35 ± 0.51 | 0.31 ± 0.47 |
| 2 hour | 0.31 ± 0.49 | 0.26 ± 0.44 |
| 4 hour | 0.07 ± 0.25 | 0.11 ± 0.31 |
| 6 hour | 0.18 ± 0.38 | 0.15 ± 0.36 |
| 9 hour | 0.14 ± 0.34 | 0.12 ± 0.33 |
| 12 hour | 0.18 ± 0.42 | 0.19 ± 0.43 |
| 24 hour | 0.20 ± 0.44 | 0.16 ± 0.41 |
| 48 hour | 0.01 ± 0.11 | 0.07 ± 0.15 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Normal Saline Injection | — | 0/74 (0%) | 0/74 (0%) |
| Ropivacaine With Epinephrine Injection | — | 0/74 (0%) | 0/74 (0%) |
All patients referred for BABA robotic or endoscopic thyroidectomy at Seoul National University Bundang Hospital
| Age, Continuous(years) | Normal Saline Injection | Ropivacaine With Epinephrine Injection | Total |
|---|---|---|---|
| Mean | 38.0 ± 9.3 | 35.5 ± 8.8 | 36.1 ± 9.7 |
| Sex: Female, Male(Participants) | Normal Saline Injection | Ropivacaine With Epinephrine Injection | Total |
|---|---|---|---|
| Female | 69 | 66 | 135 |
| Male | 5 | 8 | 13 |
| Preoperative thyroid function test (T3, ng/dL)(ng/dL) | Normal Saline Injection | Ropivacaine With Epinephrine Injection | Total |
|---|---|---|---|
| Mean | 121.8 ± 15.0 | 123.3 ± 25.1 | 122.5 ± 20.6 |
| Preoperative thyroid function test (free T4, ng/dL)(ng/dL) | Normal Saline Injection | Ropivacaine With Epinephrine Injection | Total |
|---|---|---|---|
| Mean | 1.2 ± 0.3 | 1.2 ± 0.4 | 1.2 ± 0.4 |
| Preoperative thyroid function test (TSH, uIU/mL)(uIU/mL) | Normal Saline Injection | Ropivacaine With Epinephrine Injection | Total |
|---|---|---|---|
| Mean | 1.8 ± 1.0 | 2.2 ± 1.7 | 2.0 ± 1.4 |
| Method of operation (robotic/endoscopic)(participants) | Normal Saline Injection | Ropivacaine With Epinephrine Injection | Total |
|---|---|---|---|
| Robotic | 53 | 55 | 108 |
| Endoscopic | 21 | 19 | 40 |
| Extent of operation (Right/Left/Total)(participants) | Normal Saline Injection | Ropivacaine With Epinephrine Injection | Total |
|---|---|---|---|
| Right | 26 | 29 | 55 |
| Left | 28 | 24 | 52 |
| Total | 20 | 21 | 41 |
Plan to share: Undecided
The record gives a start of May 2014, a primary completion of May 2016 and a completion of Jun 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2017, 1 year 3 months after primary completion.
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Studies of the drugs tested here: Ropivacaine · Epinephrine
Seoul National University Hospital →