Trial Outcomes & Findings for Persistent Pain After CS Delivery (NCT NCT01996592)
NCT ID: NCT01996592
Last Updated: 2018-08-13
Results Overview
By identifying preoperative risk factors for chronic pain and mapping out the trajectory of pain after cesarean delivery, we may be able to use novel pharmacologic or psychological interventions to alter postoperative pain trajectories. Two predominant risk factors have been determined thus far to put those at risk. They are emotional distress/depression and perceived stress. The 530 participants recovery pain scores were broken down into 3 subgroups--group 1 is those who had the fastest recovery, group 2 which is the "average" recovery, and group 3 which is the group with the slowest recovery.
COMPLETED
575 participants
60 days
2018-08-13
Participant Flow
Elective cesarean section patients \>/= 18 years of age who agree to be contacted for 8 weeks after delivery to obtain pain scores
Participant milestones
| Measure |
Cesarean Section Deliveries
those subjects having an elective cesarean section will complete an informed consent form, complete the preoperative questionnaire, and then be contacted for 60 days postoperatively
|
|---|---|
|
Overall Study
STARTED
|
575
|
|
Overall Study
COMPLETED
|
530
|
|
Overall Study
NOT COMPLETED
|
45
|
Reasons for withdrawal
| Measure |
Cesarean Section Deliveries
those subjects having an elective cesarean section will complete an informed consent form, complete the preoperative questionnaire, and then be contacted for 60 days postoperatively
|
|---|---|
|
Overall Study
no response to text/no diary entry
|
32
|
|
Overall Study
change in surgical date
|
4
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
change in mode of delivery
|
4
|
Baseline Characteristics
575 enrolled; 530 analyzed. 45 subjects were excluded for the following reasons: no response to text/no diary entry: 32 change in surgical date: 4 withdrew consent prior to study initiation: 5 change in mode of delivery: 4
Baseline characteristics by cohort
| Measure |
Cesarean Section Deliveries
n=530 Participants
those subjects having an elective cesarean section will complete an informed consent form, complete the preoperative questionnaire, and then be contacted for 60 days postoperatively
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
530 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
530 Participants
n=99 Participants • 575 enrolled; 530 analyzed. 45 subjects were excluded for the following reasons: no response to text/no diary entry: 32 change in surgical date: 4 withdrew consent prior to study initiation: 5 change in mode of delivery: 4
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants • 575 enrolled; 530 analyzed. 45 subjects were excluded for the following reasons: no response to text/no diary entry: 32 change in surgical date: 4 withdrew consent prior to study initiation: 5 change in mode of delivery: 4
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants • 575 enrolled; 530 analyzed. 45 subjects were excluded for the following reasons: no response to text/no diary entry: 32 change in surgical date: 4 withdrew consent prior to study initiation: 5 change in mode of delivery: 4
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants • 575 enrolled; 530 analyzed. 45 subjects were excluded for the following reasons: no response to text/no diary entry: 32 change in surgical date: 4 withdrew consent prior to study initiation: 5 change in mode of delivery: 4
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants • 575 enrolled; 530 analyzed. 45 subjects were excluded for the following reasons: no response to text/no diary entry: 32 change in surgical date: 4 withdrew consent prior to study initiation: 5 change in mode of delivery: 4
|
|
Race (NIH/OMB)
Black or African American
|
138 Participants
n=99 Participants • 575 enrolled; 530 analyzed. 45 subjects were excluded for the following reasons: no response to text/no diary entry: 32 change in surgical date: 4 withdrew consent prior to study initiation: 5 change in mode of delivery: 4
|
|
Race (NIH/OMB)
White
|
384 Participants
n=99 Participants • 575 enrolled; 530 analyzed. 45 subjects were excluded for the following reasons: no response to text/no diary entry: 32 change in surgical date: 4 withdrew consent prior to study initiation: 5 change in mode of delivery: 4
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants • 575 enrolled; 530 analyzed. 45 subjects were excluded for the following reasons: no response to text/no diary entry: 32 change in surgical date: 4 withdrew consent prior to study initiation: 5 change in mode of delivery: 4
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants • 575 enrolled; 530 analyzed. 45 subjects were excluded for the following reasons: no response to text/no diary entry: 32 change in surgical date: 4 withdrew consent prior to study initiation: 5 change in mode of delivery: 4
|
PRIMARY outcome
Timeframe: 60 daysBy identifying preoperative risk factors for chronic pain and mapping out the trajectory of pain after cesarean delivery, we may be able to use novel pharmacologic or psychological interventions to alter postoperative pain trajectories. Two predominant risk factors have been determined thus far to put those at risk. They are emotional distress/depression and perceived stress. The 530 participants recovery pain scores were broken down into 3 subgroups--group 1 is those who had the fastest recovery, group 2 which is the "average" recovery, and group 3 which is the group with the slowest recovery.
Outcome measures
| Measure |
Group 1-perceived Stress Scores
n=307 Participants
Subjects who had the fastest recovery
|
Group 2 Perceived Stress Scale
n=170 Participants
Subjects who experienced average recovery
|
Group 3 Perceived Stress Scale
n=53 Participants
Subjects who experienced the slowest recovery from surgery
|
|---|---|---|---|
|
Persistent Pain-PERCEIVED STRESS Scores Stratified by the Rate of Recovery
|
11.4 units on a scale
Standard Deviation 5.8
|
12.9 units on a scale
Standard Deviation 5.8
|
15.4 units on a scale
Standard Deviation 5.4
|
PRIMARY outcome
Timeframe: 60 daysBy identifying preoperative risk factors for chronic pain and mapping out the trajectory of pain after cesarean delivery, we may be able to use novel pharmacologic or psychological interventions to alter postoperative pain trajectories. Two predominant risk factors have been determined thus far to put those at risk. They are emotional distress/depression and perceived stress. The 530 participants recovery pain scores were broken down into 3 subgroups--group 1 is those who had the fastest recovery, group 2 which is the "average" recovery, and group 3 which is the group with the slowest recovery. PROMIS Emotional Distress-Depression Short form utilized for this outcome. scoring for this ranges from 8-40, with the higher the score the worse the distress
Outcome measures
| Measure |
Group 1-perceived Stress Scores
n=307 Participants
Subjects who had the fastest recovery
|
Group 2 Perceived Stress Scale
n=170 Participants
Subjects who experienced average recovery
|
Group 3 Perceived Stress Scale
n=53 Participants
Subjects who experienced the slowest recovery from surgery
|
|---|---|---|---|
|
Persistent Pain-EMOTIONAL DISTRESS
|
10.7 units on a scale
Standard Deviation 3.8
|
11.5 units on a scale
Standard Deviation 4.2
|
12.8 units on a scale
Standard Deviation 4.5
|
Adverse Events
Cesarean Section Deliveries
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place