REBT: Efficacy of Ropivacaine (With Epinephrine) in BABA Endoscopic and Robotic Thyroidectomy

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02112370
• Collaborator: Seoul National University Bundang Hospital (Other)
• Enrollment: 148
• Locations: 2
• Arms: 2
• Duration (Months): 25
• Patients Per Site: 74
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

To assess the pain relief and the hemodynamic stability of ropivacaine with epinephrine in BABA endoscopic and robotic thyroidectomy.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Neoplasm; Goiter	Drug: Ropivacaine with epinephrine injection; Other: Placebo	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 148 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase 3 Study of Ropivacaine (With Epinephrine) in BABA Endoscopic and Robotic Thyroidectomy
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.	Other: Placebo; 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection for the placebo group.; Other Names: CJ 0.9% Normal Saline injection 100cc Insurance code: A11601752
Experimental: 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.	Drug: 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 for the experiment group.; Other Names: Hanlim ropiva injection 7.5 mg/mL (20cc) Insurance code: A37804211 Jeil epinephrine injection 1 mg/mL (1cc) Insurance code: A04900341

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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

6. 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)

7. Pain Killer Dose [0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation]

   Change in pain killer usage with time

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do	Korea, Republic of	463-707
2	Seoul National University Hospital	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

• Seoul National University Hospital
• Seoul National University Bundang Hospital

Investigators

• Principal Investigator: Kyu Eun Lee, MD, PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Pharmacology of regional anaesthesia

Publications

• Choe JH, Kim SW, Chung KW, Park KS, Han W, Noh DY, Oh SK, Youn YK. Endoscopic thyroidectomy using a new bilateral axillo-breast approach. World J Surg. 2007 Mar;31(3):601-6.
• Choi JY, Lee KE, Chung KW, Kim SW, Choe JH, Koo do H, Kim SJ, Lee J, Chung YS, Oh SK, Youn YK. Endoscopic thyroidectomy via bilateral axillo-breast approach (BABA): review of 512 cases in a single institute. Surg Endosc. 2012 Apr;26(4):948-55. doi: 10.1007/s00464-011-1973-x. Epub 2011 Nov 4.
• Hristovska AM, Kristensen BB, Rasmussen MA, Rasmussen YH, Elving LB, Nielsen CV, Kehlet H. Effect of systematic local infiltration analgesia on postoperative pain in vaginal hysterectomy: a randomized, placebo-controlled trial. Acta Obstet Gynecol Scand. 2014 Mar;93(3):233-8. doi: 10.1111/aogs.12319.
• Kim SJ, Lee KE, Myong JP, Koo do H, Lee J, Youn YK. Prospective study of sensation in anterior chest areas before and after a bilateral axillo-breast approach for endoscopic/robotic thyroid surgery. World J Surg. 2013 May;37(5):1147-53. doi: 10.1007/s00268-013-1934-8.
• Kwon H, Koo do H, Choi JY, Kim E, Lee KE, Youn YK. Bilateral axillo-breast approach robotic thyroidectomy for Graves' disease: an initial experience in a single institute. World J Surg. 2013 Jul;37(7):1576-81. doi: 10.1007/s00268-013-2027-4.
• Lee KE, Choi JY, Youn YK. Bilateral axillo-breast approach robotic thyroidectomy. Surg Laparosc Endosc Percutan Tech. 2011 Aug;21(4):230-6. doi: 10.1097/SLE.0b013e31822d0455.
• Lee KE, Kim E, Koo do H, Choi JY, Kim KH, Youn YK. Robotic thyroidectomy by bilateral axillo-breast approach: review of 1,026 cases and surgical completeness. Surg Endosc. 2013 Aug;27(8):2955-62. doi: 10.1007/s00464-013-2863-1. Epub 2013 Feb 23.
• Lee KE, Koo do H, Im HJ, Park SK, Choi JY, Paeng JC, Chung JK, Oh SK, Youn YK. Surgical completeness of bilateral axillo-breast approach robotic thyroidectomy: comparison with conventional open thyroidectomy after propensity score matching. Surgery. 2011 Dec;150(6):1266-74. doi: 10.1016/j.surg.2011.09.015.
• Lee KE, Rao J, Youn YK. Endoscopic thyroidectomy with the da Vinci robot system using the bilateral axillary breast approach (BABA) technique: our initial experience. Surg Laparosc Endosc Percutan Tech. 2009 Jun;19(3):e71-5. doi: 10.1097/SLE.0b013e3181a4ccae.
• Miratashi SA, Behdad S, Ayatollahi V, Ahmadi A. Hemodynamic effects of intraocular epinephrine during cataract surgery: a double blinded placebo controlled randomized clinical trial. Nepal J Ophthalmol. 2012 Jul-Dec;4(2):288-94. doi: http://dx.doi.org/10.3126/nepjoph.v4i2.6546.

• Responsible Party: Kyu Eun Lee, Associate Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT02112370
• Other Study ID Numbers: B-1403/242-006
• First Posted: Apr 11, 2014
• Last Update Posted: Aug 4, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Kyu Eun Lee, Associate Professor, Seoul National University Hospital: Ropivacaine; Epinephrine; Endoscopy; Robotics; Thyroidectomy
• Additional relevant MeSH terms: Thyroid Neoplasms; Epinephrine; Racepinephrine; Ropivacaine; Epinephryl borate

Study Results

Participant Flow

Arm/Group Title	Normal Saline Injection	Ropivacaine With Epinephrine Injection
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	74	74
COMPLETED	74	74
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Normal Saline Injection	Ropivacaine With Epinephrine Injection	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	74	74	148
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.0 (9.3)	35.5 (8.8)	36.1 (9.7)
Sex: Female, Male (Count of Participants)
Female	69 93.2%	66 89.2%	135 91.2%
Male	5 6.8%	8 10.8%	13 8.8%
Preoperative thyroid function test (T3, ng/dL) (ng/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ng/dL]	121.8 (15.0)	123.3 (25.1)	122.5 (20.6)
Preoperative thyroid function test (free T4, ng/dL) (ng/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ng/dL]	1.2 (0.3)	1.2 (0.4)	1.2 (0.4)
Preoperative thyroid function test (TSH, uIU/mL) (uIU/mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [uIU/mL]	1.8 (1.0)	2.2 (1.7)	2.0 (1.4)
Method of operation (robotic/endoscopic) (participants) [Number]
Robotic	53 71.6%	55 74.3%	108 73%
Endoscopic	21 28.4%	19 25.7%	40 27%
Extent of operation (Right/Left/Total) (participants) [Number]
Right	26 35.1%	29 39.2%	55 37.2%
Left	28 37.8%	24 32.4%	52 35.1%
Total	20 27%	21 28.4%	41 27.7%

Outcome Measures

1. Primary Outcome

Title	NRS Pain Scores for the First 12 Hours
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Normal Saline Injection	Ropivacaine With Epinephrine Injection
Arm/Group Description	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.	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.
Measure Participants	74	74
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Normal Saline Injection, Ropivacaine With Epinephrine Injection
	Comments	Swallowing difficulty
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.008
	Comments	threshold p value for significance < 0.05
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Normal Saline Injection, Ropivacaine With Epinephrine Injection
	Comments	Anterior neck pain
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.016
	Comments	threshold p value for significance < 0.05
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Normal Saline Injection, Ropivacaine With Epinephrine Injection
	Comments	Right chest pain
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.019
	Comments	threshold p value for significance < 0.05
	Method	t-test, 2 sided
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Normal Saline Injection, Ropivacaine With Epinephrine Injection
	Comments	Left chest pain
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.035
	Comments	threshold p value for significance < 0.05
	Method	t-test, 2 sided
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Normal Saline Injection, Ropivacaine With Epinephrine Injection
	Comments	Back pain
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.089
	Comments	threshold p value for significance < 0.05
	Method	t-test, 2 sided
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Normal Saline Injection, Ropivacaine With Epinephrine Injection
	Comments	Posterior neck pain
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.634
	Comments	threshold p value for significance < 0.05
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Maximum of Measured Systolic Blood Pressures
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Normal Saline Injection	Ropivacaine With Epinephrine Injection
Arm/Group Description	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.	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.
Measure Participants	74	74
Mean (Standard Deviation) [mmHg]	142 (16.5)	145 (18.9)

3. Secondary Outcome

Title	Maximum of Measured Diastolic Blood Pressures
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Normal Saline Injection	Ropivacaine With Epinephrine Injection
Arm/Group Description	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.	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.
Measure Participants	74	74
Mean (Standard Deviation) [mmHg]	91 (14.9)	86 (19.2)

4. Secondary Outcome

Title	Maximum of Measured Heart Rates
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Normal Saline Injection	Ropivacaine With Epinephrine Injection
Arm/Group Description	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.	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.
Measure Participants	74	74
Mean (Standard Deviation) [beats per minute]	88 (16.1)	99 (13.3)

5. Secondary Outcome

Title	Blood Loss Amount
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Normal Saline Injection	Ropivacaine With Epinephrine Injection
Arm/Group Description	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.	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.
Measure Participants	74	74
Mean (Standard Deviation) [ml]	30 (58.2)	18 (40.5)

6. Secondary Outcome

Title	Operation Time
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Normal Saline Injection	Ropivacaine With Epinephrine Injection
Arm/Group Description	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.	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.
Measure Participants	74	74
Mean (Standard Deviation) [minutes]	163.6 (54.1)	155.3 (46.8)

7. Secondary Outcome

Title	NRS Change
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Normal Saline Injection	Ropivacaine With Epinephrine Injection
Arm/Group Description	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.	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.
Measure Participants	74	74
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)

8. Secondary Outcome

Title	Pain Killer Dose
Description	Change in pain killer usage with time
Time Frame	0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Normal Saline Injection	Ropivacaine With Epinephrine Injection
Arm/Group Description	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.	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.
Measure Participants	74	74
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)

Adverse Events

Arm/Group Title	Normal Saline Injection		Ropivacaine With Epinephrine Injection
Arm/Group Description	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.		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.
All Cause Mortality
	Normal Saline Injection		Ropivacaine With Epinephrine Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Normal Saline Injection		Ropivacaine With Epinephrine Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/74 (0%)		0/74 (0%)
Other (Not Including Serious) Adverse Events
	Normal Saline Injection		Ropivacaine With Epinephrine Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/74 (0%)		0/74 (0%)

Limitations/Caveats

Single-institution study We did not directly examine the vasoconstrictive properties of epinephrine in helping reduce bleeding. Issue regarding importance of statistical vs. clinical significance of the pain score remains to be addressed

More Information

Certain Agreements

Principal Investigators are NOT 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.