Trial Outcomes & Findings for Serratus Anterior Plane Block in Patients Undergoing Mastectomy (NCT NCT03154658)

Results Overview

Measures number of milligrams morphine equivalents each subject receives

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

66 participants

Primary outcome timeframe

24 hours post block

Results posted on

2021-03-16

Participant Flow

Participant milestones

Participant milestones
Measure	Sub-serratus Regional Block A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site deep to the serratus anterior muscle. Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.	Supra-serratus Regional Block A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site superficial to the serratus anterior muscle. Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.
Overall Study STARTED	33	33
Overall Study COMPLETED	32	32
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sub-serratus Regional Block n=32 Participants A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site deep to the serratus anterior muscle. Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.	Supra-serratus Regional Block n=32 Participants A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site superficial to the serratus anterior muscle. Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.	Total n=64 Participants Total of all reporting groups
Age, Continuous	54.7 years STANDARD_DEVIATION 14.2 • n=32 Participants	52.0 years STANDARD_DEVIATION 11.0 • n=32 Participants	53.3 years STANDARD_DEVIATION 12.7 • n=64 Participants
Sex: Female, Male Female	32 Participants n=32 Participants	32 Participants n=32 Participants	64 Participants n=64 Participants
Sex: Female, Male Male	0 Participants n=32 Participants	0 Participants n=32 Participants	0 Participants n=64 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	32 Participants n=32 Participants	32 Participants n=32 Participants	64 Participants n=64 Participants
BMI	27.9 kg/m^2 STANDARD_DEVIATION 6.4 • n=32 Participants	30.2 kg/m^2 STANDARD_DEVIATION 10.5 • n=32 Participants	29.0 kg/m^2 STANDARD_DEVIATION 8.7 • n=64 Participants
Intraoperative length	321.6 minutes STANDARD_DEVIATION 110.1 • n=32 Participants	323.0 minutes STANDARD_DEVIATION 114.7 • n=32 Participants	322.3 minutes STANDARD_DEVIATION 111.6 • n=64 Participants
Tissue expander placement	24 participants n=32 Participants	27 participants n=32 Participants	51 participants n=64 Participants
Axillary node dissection	3 participants n=32 Participants	2 participants n=32 Participants	5 participants n=64 Participants

PRIMARY outcome

Timeframe: 24 hours post block

Measures number of milligrams morphine equivalents each subject receives

Outcome measures

Outcome measures
Measure	Sub-serratus Regional Block n=32 Participants A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site deep to the serratus anterior muscle. Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.	Supra-serratus Regional Block n=32 Participants A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site superficial to the serratus anterior muscle. Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.
Opioid Consumption	113.5 milligrams oral morphine equivalent Interval 86.5 to 176.2	147 milligrams oral morphine equivalent Interval 126.5 to 227.0

SECONDARY outcome

Timeframe: 24 hours post block

Measures the change in pain scores on a 0-10 Numeric Rating Scale where 0 is no pain and 10 is the maximum pain.

Outcome measures

Outcome measures
Measure	Sub-serratus Regional Block n=32 Participants A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site deep to the serratus anterior muscle. Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.	Supra-serratus Regional Block n=32 Participants A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site superficial to the serratus anterior muscle. Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.
Maximum Post-operative Pain Score	5.2 units on a scale Standard Deviation 4.4	5.9 units on a scale Standard Deviation 5.2

SECONDARY outcome

Timeframe: 24 hours post block

Pain satisfaction with regards to post-operative pain management within the first 24 hours post op on a 1-5 Likert scale of (1 poor, 2 fair, 3 good, 4 very good, 5 excellent).

Outcome measures

Outcome measures
Measure	Sub-serratus Regional Block n=32 Participants A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site deep to the serratus anterior muscle. Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.	Supra-serratus Regional Block n=32 Participants A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site superficial to the serratus anterior muscle. Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.
Patient Satisfaction Scale	3.62 units on a scale Standard Deviation 1.01	3.24 units on a scale Standard Deviation 0.91

SECONDARY outcome

Timeframe: 24 hours post block

Measures the type and frequency of anti-emetics subjects receive

Outcome measures

Outcome measures
Measure	Sub-serratus Regional Block n=32 Participants A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site deep to the serratus anterior muscle. Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.	Supra-serratus Regional Block n=32 Participants A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site superficial to the serratus anterior muscle. Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.
Number of Participants With Nausea/Vomiting	14 participants	15 participants

SECONDARY outcome

Timeframe: 10 Days

Measures total number of days subject is hospitalized, including day of surgery

Outcome measures

Outcome measures
Measure	Sub-serratus Regional Block n=32 Participants A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site deep to the serratus anterior muscle. Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.	Supra-serratus Regional Block n=32 Participants A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site superficial to the serratus anterior muscle. Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.
Length of Stay	2 days Interval 1.0 to 2.0	2 days Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: 24 hours post block

Measures the total duration of sleep in minutes that subjects report sleeping on the night after surgery between postoperative days 0 and 1

Outcome measures

Outcome measures
Measure	Sub-serratus Regional Block n=32 Participants A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site deep to the serratus anterior muscle. Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.	Supra-serratus Regional Block n=32 Participants A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site superficial to the serratus anterior muscle. Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.
Sleep Duration Night of Postoperative Day 0	315 minutes Standard Deviation 114	276 minutes Standard Deviation 80.4

SECONDARY outcome

Timeframe: Time from procedure needle insertion until needle removal, estimate less than 5 minutes

Measures total time for block to take effect

Outcome measures

Outcome measures
Measure	Sub-serratus Regional Block n=32 Participants A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site deep to the serratus anterior muscle. Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.	Supra-serratus Regional Block n=32 Participants A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site superficial to the serratus anterior muscle. Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.
Block Performance Time	8 minutes Interval 6.0 to 10.0	7.5 minutes Interval 5.5 to 11.5

Adverse Events

Sub-serratus Regional Block

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Supra-serratus Regional Block

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sub-serratus Regional Block n=32 participants at risk A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site deep to the serratus anterior muscle. Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.	Supra-serratus Regional Block n=32 participants at risk A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site superficial to the serratus anterior muscle. Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.
Gastrointestinal disorders Nausea in first 24 hours after surgery	43.8% 14/32 • 24 hours	46.9% 15/32 • 24 hours

Additional Information

Anthony Machi M.D.

University of Texas Southwestern

Phone: 2146486400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place