Trial Outcomes & Findings for A Prospective Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction (NCT NCT02044302)

Results Overview

The patient records their feeling of pain scaled in a subjective scale from 0 to 10. 0 means that there is no pain and 10 means that the worst pain you had. The other numbers mean that pain is in perceived as in between. The investigator will also mark a pain score in the facial expression scale of Mosby© by evaluating your facial appearance.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Post Operation Day 1

Results posted on

2017-04-10

Participant Flow

Participant milestones

Participant milestones
Measure	Blinded Group A	Blinded Group B
Overall Study STARTED	2	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Blinded Group A	Blinded Group B
Overall Study study terminated	2	0

Baseline Characteristics

A Prospective Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Blinded Group A n=2 Participants	Blinded Group B	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Post Operation Day 1

Population: The study was terminated after 2 subjects enrolled and outcomes were never fully collected not summarized.

The patient records their feeling of pain scaled in a subjective scale from 0 to 10. 0 means that there is no pain and 10 means that the worst pain you had. The other numbers mean that pain is in perceived as in between. The investigator will also mark a pain score in the facial expression scale of Mosby© by evaluating your facial appearance.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Post Operation Week 1

Population: The study was terminated after 2 subjects enrolled and outcomes were never summarized.

The patient records their feeling of pain scaled in a subjective scale from 0 to 10. 0 means that there is no pain and 10 means that the worst pain. The other numbers mean that pain is perceived as in between. The investigator will also mark a pain score in the facial expression scale of Mosby© by evaluating your facial appearance.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Post Operation One Month

Population: The study was terminated after 2 subjects enrolled and outcomes were never summarized.

The patient records their feeling of pain scaled in a subjective scale from 0 to 10. 0 means that there is no pain and 10 means that the worst pain. The other numbers mean that pain is perceived as in between. The investigator will also mark a pain score in the facial expression scale of Mosby© by evaluating your facial appearance.

Outcome measures

Outcome data not reported

Adverse Events

Terminated Cohort

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

Katisha Brown CPC

Yale Center for Clinical Investigations

Phone: (203) 737-7495

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place