Trial Outcomes & Findings for Effect of Mu-opioid Receptor Genetics on 3 Doses of Spinal Morphine for Postoperative Analgesia After Cesarean Section (NCT NCT01465191)

NCT ID: NCT01465191

Last Updated: 2020-12-10

Results Overview

IV morphine use in milligrams, by participant-controlled analgesia will be assessed every 6 hours for 24 hours postoperatively.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

169 participants

Primary outcome timeframe

24 hours

Results posted on

2020-12-10

Participant Flow

Participant milestones

Participant milestones
Measure
50 Micrograms Spinal Morphine
Subjects will receive 50 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section After interim analysis, the genetics part of the analysis was dropped and the study completed.
100 mcg Spinal Morphine
Subjects will receive 100 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section After interim analysis, the genetics part of the analysis was dropped and the study completed.
150 mcg Spinal Morphine
Subjects will receive 150 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section After interim analysis, the genetics part of the analysis was dropped and the study completed.
Overall Study
STARTED
56
63
50
Overall Study
COMPLETED
47
54
43
Overall Study
NOT COMPLETED
9
9
7

Reasons for withdrawal

Reasons for withdrawal
Measure
50 Micrograms Spinal Morphine
Subjects will receive 50 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section After interim analysis, the genetics part of the analysis was dropped and the study completed.
100 mcg Spinal Morphine
Subjects will receive 100 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section After interim analysis, the genetics part of the analysis was dropped and the study completed.
150 mcg Spinal Morphine
Subjects will receive 150 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section After interim analysis, the genetics part of the analysis was dropped and the study completed.
Overall Study
Protocol Violation
6
3
3
Overall Study
Lost to Follow-up
3
6
4

Baseline Characteristics

Effect of Mu-opioid Receptor Genetics on 3 Doses of Spinal Morphine for Postoperative Analgesia After Cesarean Section

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
50 Micrograms Spinal Morphine
n=47 Participants
these subjects will receive 50 mcg spinal morphine
100 Micrograms Spinal Morphine
n=54 Participants
these subjects will receive 100 mcg spinal morphine
150 Micrograms Spinal Morphine
n=43 Participants
these subjects will receive 150 mcg spinal morphine
Total
n=144 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
0 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
47 Participants
n=5 Participants
54 Participants
n=7 Participants
43 Participants
n=5 Participants
144 Participants
n=4 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Continuous
33 years
STANDARD_DEVIATION 6 • n=5 Participants
33 years
STANDARD_DEVIATION 5 • n=7 Participants
33 years
STANDARD_DEVIATION 6 • n=5 Participants
33 years
STANDARD_DEVIATION 4 • n=4 Participants
Sex: Female, Male
Female
47 Participants
n=5 Participants
54 Participants
n=7 Participants
43 Participants
n=5 Participants
144 Participants
n=4 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Region of Enrollment
United States
47 participants
n=5 Participants
54 participants
n=7 Participants
43 participants
n=5 Participants
144 participants
n=4 Participants

PRIMARY outcome

Timeframe: 24 hours

IV morphine use in milligrams, by participant-controlled analgesia will be assessed every 6 hours for 24 hours postoperatively.

Outcome measures

Outcome measures
Measure
50 Micrograms Spinal Morphine
n=47 Participants
Subjects will receive 50 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
100 Micrograms Spinal Morphine
n=54 Participants
Subjects will receive 100 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
150 Micrograms Spinal Morphine
n=43 Participants
Subjects will receive 150 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
Milligrams of Intravenous Morphine Used by Participant in First 24 Hours Postoperatively
18 Milligrams
Interval 8.0 to 29.0
14 Milligrams
Interval 6.0 to 27.0
15 Milligrams
Interval 5.0 to 23.0

SECONDARY outcome

Timeframe: 6 hours post-operatively

Visual analog pain scale measures pain on a 100 millimeter (mm) scale. Participants make a mark on the scale with one end labeled "None" (0mm) and the other labeled "Worst pain imaginable" (100mm). Pain measured at rest and with movement.

Outcome measures

Outcome measures
Measure
50 Micrograms Spinal Morphine
n=47 Participants
Subjects will receive 50 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
100 Micrograms Spinal Morphine
n=54 Participants
Subjects will receive 100 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
150 Micrograms Spinal Morphine
n=43 Participants
Subjects will receive 150 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
Visual Analog Scale (VAS) Pain at 6 Hours
Rest
20 mm
Interval 10.0 to 39.0
25 mm
Interval 8.0 to 43.0
15 mm
Interval 2.0 to 35.0
Visual Analog Scale (VAS) Pain at 6 Hours
Movement
43 mm
Interval 27.0 to 62.0
43 mm
Interval 28.0 to 65.0
30 mm
Interval 13.0 to 52.0

SECONDARY outcome

Timeframe: 12 hours post-operatively

Visual analog pain scale measures pain on a 100 millimeter (mm) scale. Participants make a mark on the scale with one end labeled "None" (0mm) and the other labeled "Worst pain imaginable" (100mm). Pain measured at rest and with movement.

Outcome measures

Outcome measures
Measure
50 Micrograms Spinal Morphine
n=47 Participants
Subjects will receive 50 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
100 Micrograms Spinal Morphine
n=54 Participants
Subjects will receive 100 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
150 Micrograms Spinal Morphine
n=43 Participants
Subjects will receive 150 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
Visual Analog Scale (VAS) Pain at 12 Hours
Rest
20 mm
Interval 0.0 to 35.0
15 mm
Interval 0.0 to 36.0
10 mm
Interval 3.0 to 22.0
Visual Analog Scale (VAS) Pain at 12 Hours
Movement
30 mm
Interval 10.0 to 60.0
35 mm
Interval 17.0 to 63.0
30 mm
Interval 11.0 to 62.0

SECONDARY outcome

Timeframe: 18 hours post-operatively

Visual analog pain scale measures pain on a 100 millimeter (mm) scale. Participants make a mark on the scale with one end labeled "None" (0mm) and the other labeled "Worst pain imaginable" (100mm). Pain measured at rest and with movement.

Outcome measures

Outcome measures
Measure
50 Micrograms Spinal Morphine
n=47 Participants
Subjects will receive 50 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
100 Micrograms Spinal Morphine
n=54 Participants
Subjects will receive 100 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
150 Micrograms Spinal Morphine
n=43 Participants
Subjects will receive 150 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
Visual Analog Scale (VAS) Pain at 18 Hours
Rest
17 mm
Interval 0.0 to 35.0
11 mm
Interval 0.0 to 28.0
5 mm
Interval 0.0 to 19.0
Visual Analog Scale (VAS) Pain at 18 Hours
Movement
32 mm
Interval 10.0 to 50.0
30 mm
Interval 0.0 to 40.0
26 mm
Interval 0.0 to 40.0

SECONDARY outcome

Timeframe: 24 hours post-operatively

Visual analog pain scale measures pain on a 100 millimeter (mm) scale. Participants make a mark on the scale with one end labeled "None" (0mm) and the other labeled "Worst pain imaginable" (100mm). Pain measured at rest and with movement.

Outcome measures

Outcome measures
Measure
50 Micrograms Spinal Morphine
n=47 Participants
Subjects will receive 50 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
100 Micrograms Spinal Morphine
n=54 Participants
Subjects will receive 100 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
150 Micrograms Spinal Morphine
n=43 Participants
Subjects will receive 150 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
Visual Analog Scale (VAS) Pain at 24 Hours
Rest
24 mm
Interval 9.0 to 43.0
21 mm
Interval 6.0 to 50.0
18 mm
Interval 0.0 to 32.0
Visual Analog Scale (VAS) Pain at 24 Hours
Movement
43 mm
Interval 22.0 to 65.0
41 mm
Interval 21.0 to 68.0
41 mm
Interval 21.0 to 68.0

SECONDARY outcome

Timeframe: 6 hours post-operatively

Visual analog nausea/vomiting scale measures nausea and vomiting on a 100mm scale. Participants make a mark on the scale with one end labeled "None" (0mm) and the other labeled "Worst Nausea/Vomiting Imaginable" (100mm).

Outcome measures

Outcome measures
Measure
50 Micrograms Spinal Morphine
n=47 Participants
Subjects will receive 50 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
100 Micrograms Spinal Morphine
n=54 Participants
Subjects will receive 100 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
150 Micrograms Spinal Morphine
n=43 Participants
Subjects will receive 150 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
Visual Analog Scale- Nausea/Vomiting at 6 Hours
0 mm
Interval 0.0 to 15.0
7 mm
Interval 0.0 to 40.0
0 mm
Interval 0.0 to 40.0

SECONDARY outcome

Timeframe: 12 hours post-operatively

Visual analog nausea/vomiting scale measures nausea and vomiting on a 100mm scale. Participants make a mark on the scale with one end labeled "None" (0mm) and the other labeled "Worst Nausea/Vomiting Imaginable" (100mm).

Outcome measures

Outcome measures
Measure
50 Micrograms Spinal Morphine
n=47 Participants
Subjects will receive 50 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
100 Micrograms Spinal Morphine
n=54 Participants
Subjects will receive 100 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
150 Micrograms Spinal Morphine
n=43 Participants
Subjects will receive 150 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
Visual Analog Scale- Nausea/Vomiting at 12 Hours
0 mm
Interval 0.0 to 5.0
0 mm
Interval 0.0 to 6.0
0 mm
Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: 18 hours post-operatively

Visual analog nausea/vomiting scale measures nausea and vomiting on a 100mm scale. Participants make a mark on the scale with one end labeled "None" (0mm) and the other labeled "Worst Nausea/Vomiting Imaginable" (100mm).

Outcome measures

Outcome measures
Measure
50 Micrograms Spinal Morphine
n=47 Participants
Subjects will receive 50 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
100 Micrograms Spinal Morphine
n=54 Participants
Subjects will receive 100 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
150 Micrograms Spinal Morphine
n=43 Participants
Subjects will receive 150 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
Visual Analog Scale- Nausea/Vomiting at 18 Hours
0 mm
Interval 0.0 to 2.0
0 mm
Interval 0.0 to 0.0
0 mm
Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 24 hours post-operatively

Visual analog nausea/vomiting scale measures nausea and vomiting on a 100mm scale. Participants make a mark on the scale with one end labeled "None" (0mm) and the other labeled "Worst Nausea/Vomiting Imaginable" (100mm).

Outcome measures

Outcome measures
Measure
50 Micrograms Spinal Morphine
n=47 Participants
Subjects will receive 50 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
100 Micrograms Spinal Morphine
n=54 Participants
Subjects will receive 100 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
150 Micrograms Spinal Morphine
n=43 Participants
Subjects will receive 150 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
Visual Analog Scale- Nausea/Vomiting at 24 Hours
0 mm
Interval 0.0 to 4.0
0 mm
Interval 0.0 to 2.0
0 mm
Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 6 hours post-operatively

Visual analog pruritus scale measures itching on a 100mm scale. Participants make a mark on the scale with one end labeled "None" (0mm) and the other labeled "Worst Itching Imaginable" (100mm).

Outcome measures

Outcome measures
Measure
50 Micrograms Spinal Morphine
n=47 Participants
Subjects will receive 50 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
100 Micrograms Spinal Morphine
n=54 Participants
Subjects will receive 100 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
150 Micrograms Spinal Morphine
n=43 Participants
Subjects will receive 150 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
Visual Analog Scale Pruritus (Itching) at 6 Hours
21 mm
Interval 10.0 to 45.0
37 mm
Interval 3.0 to 73.0
39 mm
Interval 19.0 to 65.0

SECONDARY outcome

Timeframe: 12 hours post-operatively

Visual analog pruritus scale measures itching on a 100mm scale. Participants make a mark on the scale with one end labeled "None" (0mm) and the other labeled "Worst Itching Imaginable" (100mm).

Outcome measures

Outcome measures
Measure
50 Micrograms Spinal Morphine
n=47 Participants
Subjects will receive 50 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
100 Micrograms Spinal Morphine
n=54 Participants
Subjects will receive 100 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
150 Micrograms Spinal Morphine
n=43 Participants
Subjects will receive 150 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
Visual Analog Scale Pruritus (Itching) at 12 Hours
10 mm
Interval 0.0 to 20.0
23 mm
Interval 0.0 to 64.0
25 mm
Interval 0.0 to 45.0

SECONDARY outcome

Timeframe: 18 hours post-operatively

Visual analog pruritus scale measures itching on a 100mm scale. Participants make a mark on the scale with one end labeled "None" (0mm) and the other labeled "Worst Itching Imaginable" (100mm).

Outcome measures

Outcome measures
Measure
50 Micrograms Spinal Morphine
n=47 Participants
Subjects will receive 50 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
100 Micrograms Spinal Morphine
n=54 Participants
Subjects will receive 100 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
150 Micrograms Spinal Morphine
n=43 Participants
Subjects will receive 150 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
Visual Analog Scale Pruritus (Itching) at 18 Hours
9 mm
Interval 0.0 to 20.0
13 mm
Interval 0.0 to 47.0
5 mm
Interval 0.0 to 25.0

SECONDARY outcome

Timeframe: 24 hours post-operatively

Visual analog pruritus scale measures itching on a 100mm scale. Participants make a mark on the scale with one end labeled "None" (0mm) and the other labeled "Worst Itching Imaginable" (100mm).

Outcome measures

Outcome measures
Measure
50 Micrograms Spinal Morphine
n=47 Participants
Subjects will receive 50 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
100 Micrograms Spinal Morphine
n=54 Participants
Subjects will receive 100 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
150 Micrograms Spinal Morphine
n=43 Participants
Subjects will receive 150 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
Visual Analog Scale Pruritus (Itching) at 24 Hours
7 mm
Interval 0.0 to 16.0
12 mm
Interval 0.0 to 39.0
6 mm
Interval 0.0 to 30.0

SECONDARY outcome

Timeframe: 24 hours postoperatively

Visual analog patient satisfaction scale measures satisfaction with analgesia on a 100mm scale. Participants make a mark on the scale with one end labeled "Completely Dissatisfied" (0mm) and the other labeled "Completely Satisfied" (100mm).

Outcome measures

Outcome measures
Measure
50 Micrograms Spinal Morphine
n=47 Participants
Subjects will receive 50 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
100 Micrograms Spinal Morphine
n=54 Participants
Subjects will receive 100 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
150 Micrograms Spinal Morphine
n=43 Participants
Subjects will receive 150 mcg morphine in their spinal anesthetic for cesarean section Morphine: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
Visual Analog Patient Satisfaction With Analgesia at 24 Hours
85 mm
Interval 65.0 to 100.0
83 mm
Interval 67.0 to 100.0
84 mm
Interval 70.0 to 100.0

Adverse Events

50 Micrograms Spinal Morphine

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

100 Micrograms Spinal Morphine

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

150 Micrograms Spinal 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

Richard Smiley, MD

Columbia University

Phone: 212-342-2742

Results disclosure agreements

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