Trial Outcomes & Findings for Impact of the Serratus Plane Block in Pain and the Use of Opioids in Breast Surgery (NCT NCT02905149)

Results Overview

Total opioid usage in the first 24 hours (intra and postoperative) (in morphine milligrmas, fentanyl/morphine conversion = 10 mcgs/1mg). Opioid used will be fentanyl and morphine. Fentanyl will be converted in morphine milligrams equivlents to caluclate the total first 24H dose.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

First 24 hours after surgery

Results posted on

2020-03-02

Participant Flow

Participant milestones

Participant milestones
Measure	Serrato Standard anesthesia+serratus plane block. Serrato: Serratus plane block.	Control Standard anesthesia Control: Standard anesthesia
Overall Study STARTED	30	30
Overall Study COMPLETED	28	30
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Serrato Standard anesthesia+serratus plane block. Serrato: Serratus plane block.	Control Standard anesthesia Control: Standard anesthesia
Overall Study Lost to Follow-up	2	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Serrato n=30 Participants Standard anesthesia+serratus plane block. Serrato: Serratus plane block.	Control n=30 Participants Standard anesthesia Control: Standard anesthesia	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=30 Participants	18 Participants n=30 Participants	35 Participants n=60 Participants
Age, Categorical >=65 years	13 Participants n=30 Participants	12 Participants n=30 Participants	25 Participants n=60 Participants
Sex: Female, Male Female	30 Participants n=30 Participants	30 Participants n=30 Participants	60 Participants n=60 Participants
Sex: Female, Male Male	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Spain	30 participants n=30 Participants	30 participants n=30 Participants	60 participants n=60 Participants

PRIMARY outcome

Timeframe: First 24 hours after surgery

Population: 2 participants were lost to follow up because of malfunctioning of the electronic device administering the potoperative opioid

Total opioid usage in the first 24 hours (intra and postoperative) (in morphine milligrmas, fentanyl/morphine conversion = 10 mcgs/1mg). Opioid used will be fentanyl and morphine. Fentanyl will be converted in morphine milligrams equivlents to caluclate the total first 24H dose.

Outcome measures

Outcome measures
Measure	Serrato n=28 Participants Standard anesthesia+serratus plane block. Serrato: Serratus plane block.	Control n=30 Participants Standard anesthesia Control: Standard anesthesia
Total Opioid Usage	18.5 milligrams Interval 17.0 to 24.0	30 milligrams Interval 26.0 to 35.0

SECONDARY outcome

Timeframe: First 24 hours after surgery

Pain at rest and coughing at 24h postoperative (Visual analogue scale 0-10 with 0 meaning no pain and 10 meaning the worst imaginable pain). High score mean worse outcomes

Outcome measures

Outcome measures
Measure	Serrato n=28 Participants Standard anesthesia+serratus plane block. Serrato: Serratus plane block.	Control n=30 Participants Standard anesthesia Control: Standard anesthesia
Pain at Rest and Coughing Pain interf. with activities in bed	1 units on a scale Interval 0.0 to 3.0	1 units on a scale Interval 0.0 to 6.0
Pain at Rest and Coughing Worst pain in 24h	4 units on a scale Interval 3.0 to 6.0	6 units on a scale Interval 4.0 to 8.0
Pain at Rest and Coughing Least pain in 24h	0 units on a scale Interval 0.0 to 0.0	0 units on a scale Interval 0.0 to 2.0
Pain at Rest and Coughing Pain interf. with breathing or coughing	0 units on a scale Interval 0.0 to 0.0	0 units on a scale Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: First 24 hours after surgery

Time to first opioid administration on the ward

Outcome measures

Outcome measures
Measure	Serrato n=28 Participants Standard anesthesia+serratus plane block. Serrato: Serratus plane block.	Control n=30 Participants Standard anesthesia Control: Standard anesthesia
Time to First Opioid Administration on the Ward	7.95 hours Interval 4.61 to 11.28	2.9 hours Interval 0.8 to 5.0

SECONDARY outcome

Timeframe: First 24 hours after surgery

presence of nausea/vomit or apnea or urinary retention or ileus is assessed. It is a dicothomic composite (yes or no).

Outcome measures

Outcome measures
Measure	Serrato n=28 Participants Standard anesthesia+serratus plane block. Serrato: Serratus plane block.	Control n=30 Participants Standard anesthesia Control: Standard anesthesia
Presence of Opioid Related Complications	0 Participants	0 Participants

Adverse Events

Serrato

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Maria Cortell

Instituto de Investigación Sanitaria La Fe

Phone: 961246611

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place