Trial Outcomes & Findings for Expectations and Pain Control Advancement In surgeRy: The REPAIR Trial (NCT NCT03726476)

NCT ID: NCT03726476

Last Updated: 2024-07-18

Results Overview

Morphine milligram equivalents at the two weeks post-op

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

174 participants

Primary outcome timeframe

2 weeks

Results posted on

2024-07-18

Participant Flow

Participant milestones

Participant milestones
Measure
Patient Centered Pre-op Education
Patient centered pre-operative education and patient centered post-operative care. Patient centered pre-op education: To implement a patient centered education intervention to evaluate post-op narcotic use.
Routine Pre-op Education
Participants will receive routine pre-operative education and post-op will receive a standardized number of narcotics routine preop education: To implement routine patient education intervention to evaluate post-op narcotic use.
Overall Study
STARTED
86
88
Overall Study
COMPLETED
86
88
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Expectations and Pain Control Advancement In surgeRy: The REPAIR Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Patient Centered Pre-op Education
n=86 Participants
Patient centered pre-operative education and patient centered post-operative care. Patient centered pre-op education: To implement a patient centered education intervention to evaluate post-op narcotic use.
Routine Pre-op Education
n=88 Participants
Participants will receive routine pre-operative education and post-op will receive a standardized number of narcotics routine preop education: To implement routine patient education intervention to evaluate post-op narcotic use.
Total
n=174 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
86 Participants
n=5 Participants
88 Participants
n=7 Participants
174 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
53 years
n=5 Participants
55 years
n=7 Participants
54 years
n=5 Participants
Sex: Female, Male
Female
86 Participants
n=5 Participants
88 Participants
n=7 Participants
174 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
7 Participants
n=5 Participants
11 Participants
n=7 Participants
18 Participants
n=5 Participants
Race (NIH/OMB)
Asian
NA Participants
n=5 Participants
NA Participants
n=7 Participants
NA Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
NA Participants
n=5 Participants
NA Participants
n=7 Participants
NA Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
NA Participants
n=5 Participants
NA Participants
n=7 Participants
NA Participants
n=5 Participants
Race (NIH/OMB)
White
33 Participants
n=5 Participants
35 Participants
n=7 Participants
68 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=5 Participants
5 Participants
n=7 Participants
6 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
45 Participants
n=5 Participants
37 Participants
n=7 Participants
82 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Morphine milligram equivalents at the two weeks post-op

Outcome measures

Outcome measures
Measure
Patient Centered Pre-op Education
n=86 Participants
Patient centered pre-operative education and patient centered post-operative care. Patient centered pre-op education: To implement a patient centered education intervention to evaluate post-op narcotic use.
Routine Pre-op Education
n=88 Participants
Participants will receive routine pre-operative education and post-op will receive a standardized number of narcotics routine preop education: To implement routine patient education intervention to evaluate post-op narcotic use.
Opioid Use at Approximately Two Weeks Post-op
15 MME
Interval 0.0 to 75.0
22.5 MME
Interval 0.0 to 60.0

SECONDARY outcome

Timeframe: 6-8 weeks

Morphine milligram equivalents at the six to eight weeks post-op

Outcome measures

Outcome measures
Measure
Patient Centered Pre-op Education
n=86 Participants
Patient centered pre-operative education and patient centered post-operative care. Patient centered pre-op education: To implement a patient centered education intervention to evaluate post-op narcotic use.
Routine Pre-op Education
n=88 Participants
Participants will receive routine pre-operative education and post-op will receive a standardized number of narcotics routine preop education: To implement routine patient education intervention to evaluate post-op narcotic use.
Opioid Use at Approximately Six to Eight Weeks Post-op
15 MME
Interval 0.0 to 75.0
23 MME
Interval 0.0 to 68.0

Adverse Events

Patient Centered Pre-op Education

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Routine Pre-op Education

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

Cassandra Darley

University of New Mexico Health Sciences Center

Phone: 505-967-8428

Results disclosure agreements

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