Trial Outcomes & Findings for The Effect of Pectoral Blocks on Perioperative Pain in Gender Affirmation Top Surgery (NCT NCT04474366)

NCT ID: NCT04474366

Last Updated: 2023-07-03

Results Overview

Participant recorded Numerical Rating Scale (NRS) pain scores post operatively. Scale ranges from 0 to 10. 0 represents no pain at all. 10 represents most severe pain.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 50 participants
• Primary outcome timeframe: 1 week post operative
• Results posted on: 2023-07-03

Participant Flow

Participant milestones

Measure	Saline Control group will receive an injection of 20ml of saline between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of saline between the pectoralis minor and pectoralis major muscles bilaterally. Saline (0.9%): Saline injection as sham block in identical fashion as Pectoralis Nerve Block	Ropivacaine Intervention group will receive an injection of 20ml of 0.2% Ropivacaine between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of 0.2% Ropivacaine between the pectoralis minor and pectoralis major muscles bilaterally (Not to exceed 225mg or 3.5mg/kg). Ropivacaine 0.2% Injectable Solution: Ropivacaine 0.2% Injectable Solution injected as part of the Pectoralis Nerve Block
Overall Study STARTED	23	27
Overall Study COMPLETED	21	22
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Measure	Saline Control group will receive an injection of 20ml of saline between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of saline between the pectoralis minor and pectoralis major muscles bilaterally. Saline (0.9%): Saline injection as sham block in identical fashion as Pectoralis Nerve Block	Ropivacaine Intervention group will receive an injection of 20ml of 0.2% Ropivacaine between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of 0.2% Ropivacaine between the pectoralis minor and pectoralis major muscles bilaterally (Not to exceed 225mg or 3.5mg/kg). Ropivacaine 0.2% Injectable Solution: Ropivacaine 0.2% Injectable Solution injected as part of the Pectoralis Nerve Block
Overall Study Lost to Follow-up	2	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Saline n=21 Participants Control group will receive an injection of 20ml of saline between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of saline between the pectoralis minor and pectoralis major muscles bilaterally. Saline (0.9%): Saline injection as sham block in identical fashion as Pectoralis Nerve Block	Ropivacaine n=22 Participants Intervention group will receive an injection of 20ml of 0.2% Ropivacaine between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of 0.2% Ropivacaine between the pectoralis minor and pectoralis major muscles bilaterally (Not to exceed 225mg or 3.5mg/kg). Ropivacaine 0.2% Injectable Solution: Ropivacaine 0.2% Injectable Solution injected as part of the Pectoralis Nerve Block	Total n=43 Participants Total of all reporting groups
Age, Continuous	27.5 years STANDARD_DEVIATION 8.7 • n=21 Participants	27.1 years STANDARD_DEVIATION 7.2 • n=22 Participants	27.3 years STANDARD_DEVIATION 7.9 • n=43 Participants
Sex: Female, Male Female	0 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=43 Participants
Sex: Female, Male Male	21 Participants n=21 Participants	22 Participants n=22 Participants	43 Participants n=43 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	21 participants n=21 Participants	22 participants n=22 Participants	43 participants n=43 Participants

PRIMARY outcome

Timeframe: 1 week post operative

Participant recorded Numerical Rating Scale (NRS) pain scores post operatively. Scale ranges from 0 to 10. 0 represents no pain at all. 10 represents most severe pain.

Outcome measures

Measure	Saline n=22 Participants Control group will receive an injection of 20ml of saline between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of saline between the pectoralis minor and pectoralis major muscles bilaterally. Saline (0.9%): Saline injection as sham block in identical fashion as Pectoralis Nerve Block	Ropivacaine n=21 Participants Intervention group will receive an injection of 20ml of 0.2% Ropivacaine between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of 0.2% Ropivacaine between the pectoralis minor and pectoralis major muscles bilaterally (Not to exceed 225mg or 3.5mg/kg). Ropivacaine 0.2% Injectable Solution: Ropivacaine 0.2% Injectable Solution injected as part of the Pectoralis Nerve Block
Comparison of Post Operative Pain Scores	3.0 score on a scale Standard Deviation 1.8	3.6 score on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: Intraoperative

Intraoperative narcotic administration will be compared. Narcotic administration will be acquired through chart review. Total dose of IV hydromorphone intraoperatively will be collected.

Outcome measures

Measure	Saline n=21 Participants Control group will receive an injection of 20ml of saline between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of saline between the pectoralis minor and pectoralis major muscles bilaterally. Saline (0.9%): Saline injection as sham block in identical fashion as Pectoralis Nerve Block	Ropivacaine n=22 Participants Intervention group will receive an injection of 20ml of 0.2% Ropivacaine between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of 0.2% Ropivacaine between the pectoralis minor and pectoralis major muscles bilaterally (Not to exceed 225mg or 3.5mg/kg). Ropivacaine 0.2% Injectable Solution: Ropivacaine 0.2% Injectable Solution injected as part of the Pectoralis Nerve Block
Comparison of Intra Operative Narcotic Requirements	11.1 Morphine Milligram Equivalents Standard Deviation 3.5	9.8 Morphine Milligram Equivalents Standard Deviation 4.5

SECONDARY outcome

Timeframe: 1 week post operative

Self reported narcotic intake postoperatively. Number of pills taken will be recorded. Each group's number of pills will be averaged.

Outcome measures

Measure	Saline n=21 Participants Control group will receive an injection of 20ml of saline between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of saline between the pectoralis minor and pectoralis major muscles bilaterally. Saline (0.9%): Saline injection as sham block in identical fashion as Pectoralis Nerve Block	Ropivacaine n=22 Participants Intervention group will receive an injection of 20ml of 0.2% Ropivacaine between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of 0.2% Ropivacaine between the pectoralis minor and pectoralis major muscles bilaterally (Not to exceed 225mg or 3.5mg/kg). Ropivacaine 0.2% Injectable Solution: Ropivacaine 0.2% Injectable Solution injected as part of the Pectoralis Nerve Block
Comparison of Post Operative Narcotic Requirements	40.0 Morphine Milligram Equivalents Interval 15.0 to 65.0	37.5 Morphine Milligram Equivalents Interval 15.4 to 71.7

Adverse Events

Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ropivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Esther Kim

University of California, San Francisco

Phone: 415-353-9392

Email: Esther.kim@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place