Trial Outcomes & Findings for Trial Comparing Intrathecal Morphine With Placebo In Patients Undergoing Robotic Cardiac Surgery (NCT NCT03241485)

Results Overview

We anticipate that patients in the intervention groups will require less postoperative morphine for pain control.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

79 participants

Primary outcome timeframe

24 hours after surgery

Results posted on

2021-11-23

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo 42 patients were randomized to the intrathecal placebo group. This group received a normal saline injected in the spinal spice, prior to surgery.	Intrathecal Morphine 37 patients were randomized to the intrathecal morphine group. This group received 5 micrograms/kilogram of intrathecal morphine administered in the spinal space
Overall Study STARTED	42	37
Overall Study COMPLETED	37	33
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=42 Participants 42 patients were randomized to this group	Intrathecal Morphine n=37 Participants 37 patients were randomized to this group	Total n=79 Participants Total of all reporting groups
Age, Continuous	64.5 years STANDARD_DEVIATION 10 • n=42 Participants	67.3 years STANDARD_DEVIATION 10.5 • n=37 Participants	65.8 years STANDARD_DEVIATION 10.2 • n=79 Participants
Sex: Female, Male Female	9 Participants n=42 Participants	5 Participants n=37 Participants	14 Participants n=79 Participants
Sex: Female, Male Male	33 Participants n=42 Participants	32 Participants n=37 Participants	65 Participants n=79 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Weight	87 KG STANDARD_DEVIATION 14 • n=42 Participants	85 KG STANDARD_DEVIATION 14 • n=37 Participants	86.4 KG STANDARD_DEVIATION 14.2 • n=79 Participants
BMI	28.6 kg/m2 STANDARD_DEVIATION 3.6 • n=42 Participants	27.5 kg/m2 STANDARD_DEVIATION 3.2 • n=37 Participants	28 kg/m2 STANDARD_DEVIATION 3.3 • n=79 Participants
ASA Physical Status	3 Units on a scale n=42 Participants	3 Units on a scale n=37 Participants	3 Units on a scale n=79 Participants
EuroSCORE II	1 Scores on a scale STANDARD_DEVIATION 0.5 • n=42 Participants	1 Scores on a scale STANDARD_DEVIATION 0.5 • n=37 Participants	1 Scores on a scale STANDARD_DEVIATION 0.5 • n=79 Participants

PRIMARY outcome

Timeframe: 24 hours after surgery

We anticipate that patients in the intervention groups will require less postoperative morphine for pain control.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants 36 patients were analyzed for primary outcome. One patient did not receive allocated intervention (failed spinal), One PCA data was lost, and 4 patients remained intubated overnight.	Morphine n=33 Participants Intrathecal morphine group
Postoperative Morphine Consumption	59 Miligram Interval 41.0 to 79.0	28 Miligram Interval 16.0 to 46.0

SECONDARY outcome

Timeframe: First 48 hours after surgery

Patients will score their pain on a visual analog scale of 0-10. The higher the score, the worse the patients reported pain is at that time .

Outcome measures

Outcome measures
Measure	Placebo n=37 Participants 36 patients were analyzed for primary outcome. One patient did not receive allocated intervention (failed spinal), One PCA data was lost, and 4 patients remained intubated overnight.	Morphine n=33 Participants Intrathecal morphine group
Pain Score	6 score on a scale Interval 4.5 to 8.0	1.2 score on a scale Interval 0.0 to 2.5

SECONDARY outcome

Timeframe: 1-3 days after surgery, prior to discharge.

Patients will take a satisfaction survey prior to discharge, this is measured by calculating a score on a scale. This survey consist of questions that asks about the subjects post-operative experience with pain. Higher reported scores represent worse post-operative subject experience. These are ranked from a 0-10 scale, where 0 is the best experience and 10 meaning the worst experience. Questions being asked how satisfied they were with the results of the pain treatment while hospitalized, least pain in prior 24 hours, worst pain in prior 24 ours, percent time in severe pain, how much pain interfered with different activities, how much pain caused anxiety, depression, fright, helplessness, how severe were symptoms of nausea, drowsiness, itching, dizziness, and percentage pain relief in prior 24 hours.

Outcome measures

Outcome measures
Measure	Placebo n=28 Participants 36 patients were analyzed for primary outcome. One patient did not receive allocated intervention (failed spinal), One PCA data was lost, and 4 patients remained intubated overnight.	Morphine n=35 Participants Intrathecal morphine group
Patient Satisfaction	9 score on a scale Interval 7.0 to 10.0	9.5 score on a scale Interval 6.5 to 10.0

SECONDARY outcome

Timeframe: Until discharge, 2-3 days after surgery

Daily evaluation of nausea post-operatively throughout the subjects hospital stay.

Outcome measures

Outcome measures
Measure	Placebo n=37 Participants 36 patients were analyzed for primary outcome. One patient did not receive allocated intervention (failed spinal), One PCA data was lost, and 4 patients remained intubated overnight.	Morphine n=33 Participants Intrathecal morphine group
Number of Participants With Nausea	3 Participants	12 Participants

SECONDARY outcome

Timeframe: During hospital stay

Opioid related respiratory depression, post-operatively throughout the subjects hospital stay.

Outcome measures

Outcome measures
Measure	Placebo n=37 Participants 36 patients were analyzed for primary outcome. One patient did not receive allocated intervention (failed spinal), One PCA data was lost, and 4 patients remained intubated overnight.	Morphine n=33 Participants Intrathecal morphine group
Number of Participants With Respiratory Depression	0 Participants	0 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Morphine

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

Richa Dhawan

University of Chicago Medicine

Phone: 773-702-1000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place