Trial Outcomes & Findings for Patient Controlled Analgesia Pump Cues on Patient Satisfaction (NCT NCT02456909)

NCT ID: NCT02456909

Last Updated: 2021-09-08

Results Overview

Patient satisfaction with their PCA pump. Satisfaction was measured on a 0 to 10 scale, with higher numbers indicating greater satisfaction.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 176 participants
• Primary outcome timeframe: Up to 72 hours
• Results posted on: 2021-09-08

Participant Flow

Participants could not be recruited after surgery; therefore, all eligible participants were recruited, but not all received a PCA after surgery.

Participant milestones

Measure	Cues The PCA pump will be programmed to provide a cue to the end of the lockout period. Patient-Controlled Analgesia pump with Cues: The end of the lockout period will be cued via the PCA pump Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups	No Cues The PCA pump will be programmed such that no cues will be provided to the end of the lockout period (current standard of care). Patient-Controlled Analgesia pump without Cues: The PCA pump will be programmed such that no cues will be provided to the end of the lockout period. Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups
Overall Study STARTED	88	88
Overall Study COMPLETED	64	61
Overall Study NOT COMPLETED	24	27

Reasons for withdrawal

Measure	Cues The PCA pump will be programmed to provide a cue to the end of the lockout period. Patient-Controlled Analgesia pump with Cues: The end of the lockout period will be cued via the PCA pump Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups	No Cues The PCA pump will be programmed such that no cues will be provided to the end of the lockout period (current standard of care). Patient-Controlled Analgesia pump without Cues: The PCA pump will be programmed such that no cues will be provided to the end of the lockout period. Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups
Overall Study Did not receive allocated intervention	24	26
Overall Study Did not complete the primary outcome	0	1

Baseline Characteristics

Patient Controlled Analgesia Pump Cues on Patient Satisfaction

Baseline characteristics by cohort

Measure	Cues n=64 Participants The PCA pump will be programmed to provide a cue to the end of the lockout period. Patient-Controlled Analgesia pump with Cues: The end of the lockout period will be cued via the PCA pump Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups	No Cues n=61 Participants The PCA pump will be programmed such that no cues will be provided to the end of the lockout period (current standard of care). Patient-Controlled Analgesia pump without Cues: The PCA pump will be programmed such that no cues will be provided to the end of the lockout period. Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups	Total n=125 Participants Total of all reporting groups
Age, Categorical <=18 years	64 Participants n=5 Participants	61 Participants n=7 Participants	125 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	11 years n=5 Participants	11 years n=7 Participants	11 years n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	38 Participants n=7 Participants	77 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	58 Participants n=5 Participants	52 Participants n=7 Participants	110 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	48 Participants n=5 Participants	47 Participants n=7 Participants	95 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 72 hours

Population: Includes participants who completed the post-intervention survey.

Patient satisfaction with their PCA pump. Satisfaction was measured on a 0 to 10 scale, with higher numbers indicating greater satisfaction.

Outcome measures

Measure	Cues n=60 Participants The PCA pump will be programmed to provide a cue to the end of the lockout period. Patient-Controlled Analgesia pump with Cues: The end of the lockout period will be cued via the PCA pump Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups	No Cues n=60 Participants The PCA pump will be programmed such that no cues will be provided to the end of the lockout period (current standard of care). Patient-Controlled Analgesia pump without Cues: The PCA pump will be programmed such that no cues will be provided to the end of the lockout period. Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups
Patient Satisfaction Questionnaire	8 units on a scale Interval 6.0 to 9.0	7.5 units on a scale Interval 5.0 to 9.0

SECONDARY outcome

Timeframe: Post-op Days [POD] 0 - 2, up to 72 hours

Total amount of opioid consumed post-operatively in mg/kg/hour.

Outcome measures

Measure	Cues n=64 Participants The PCA pump will be programmed to provide a cue to the end of the lockout period. Patient-Controlled Analgesia pump with Cues: The end of the lockout period will be cued via the PCA pump Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups	No Cues n=61 Participants The PCA pump will be programmed such that no cues will be provided to the end of the lockout period (current standard of care). Patient-Controlled Analgesia pump without Cues: The PCA pump will be programmed such that no cues will be provided to the end of the lockout period. Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups
Opioid Consumption (Total Amount of Opioid Consumed Post-operatively) Post-op Day 0	0.0252 mg/kg/hr Interval 0.015 to 0.038	0.0248 mg/kg/hr Interval 0.015 to 0.034
Opioid Consumption (Total Amount of Opioid Consumed Post-operatively) Post-op Day 1	0.0214 mg/kg/hr Interval 0.012 to 0.031	0.0163 mg/kg/hr Interval 0.011 to 0.028
Opioid Consumption (Total Amount of Opioid Consumed Post-operatively) Post-op Day 2	0.0162 mg/kg/hr Interval 0.0045 to 0.024	0.0125 mg/kg/hr Interval 0.0057 to 0.023

SECONDARY outcome

Timeframe: Up to 72 hours

State anxiety on POD 1 and POD 2. The total score is presented as a T-score, which ranges from 0 to 100, with higher scores indicating greater levels of state anxiety. With a T-score, the mean is always 50, and the standard deviation is always 10.

Outcome measures

Measure	Cues n=64 Participants The PCA pump will be programmed to provide a cue to the end of the lockout period. Patient-Controlled Analgesia pump with Cues: The end of the lockout period will be cued via the PCA pump Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups	No Cues n=61 Participants The PCA pump will be programmed such that no cues will be provided to the end of the lockout period (current standard of care). Patient-Controlled Analgesia pump without Cues: The PCA pump will be programmed such that no cues will be provided to the end of the lockout period. Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups
Anxiety (State Anxiety on POD 1 and POD 2) POD 1	55 units on a scale Interval 48.0 to 62.0	55 units on a scale Interval 49.0 to 60.0
Anxiety (State Anxiety on POD 1 and POD 2) POD 2	53.5 units on a scale Interval 46.0 to 61.0	52 units on a scale Interval 46.0 to 58.5

Adverse Events

Cues

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

No Cues

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Cues n=64 participants at risk The PCA pump will be programmed to provide a cue to the end of the lockout period. Patient-Controlled Analgesia pump with Cues: The end of the lockout period will be cued via the PCA pump Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups	No Cues n=62 participants at risk The PCA pump will be programmed such that no cues will be provided to the end of the lockout period (current standard of care). Patient-Controlled Analgesia pump without Cues: The PCA pump will be programmed such that no cues will be provided to the end of the lockout period. Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups
Skin and subcutaneous tissue disorders Itching requiring treatment on POD 0	17.2% 11/64 • Number of events 11 • 72 hours Deaths were not assessed in this protocol.	9.7% 6/62 • Number of events 6 • 72 hours Deaths were not assessed in this protocol.

Additional Information

Keri R. Hainsworth, PhD

Medical College of Wisconsin

Phone: 414-266-6306

Email: khainswo@mcw.edu

Results disclosure agreements

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