Trial Outcomes & Findings for Severity Postoperative Pain Prediction (NCT NCT00638404)
NCT ID: NCT00638404
Last Updated: 2018-08-06
Results Overview
Outcome measure 0-100 Visual analog scale at 24 hours postoperatively, VAS of 0= no pain up to 100 =most severe pain
Recruitment status
TERMINATED
Target enrollment
300 participants
Primary outcome timeframe
evoked pain at 24 hours
Results posted on
2018-08-06
Participant Flow
200 Elective cesarean sections and 100 gynecological patients were enrolled prior to their surgery with presurgical testing completed. All subjects were then also seen postoperatively for followup
no randomization, only observational study
Participant milestones
| Measure |
1-elective Cesarean Section
Elective Cesarean Sections-preoperative questionnaire as well as audio testing completed prior to surgery with followup done 24 hours postoperatively
|
3-inpatient Gynecologic Procedures
Any in-patient gynecologic procedure-preoperative questionnaire as well as audio testing completed prior to surgery with followup done 24 hours postoperatively
|
|---|---|---|
|
Overall Study
STARTED
|
200
|
100
|
|
Overall Study
COMPLETED
|
192
|
100
|
|
Overall Study
NOT COMPLETED
|
8
|
0
|
Reasons for withdrawal
| Measure |
1-elective Cesarean Section
Elective Cesarean Sections-preoperative questionnaire as well as audio testing completed prior to surgery with followup done 24 hours postoperatively
|
3-inpatient Gynecologic Procedures
Any in-patient gynecologic procedure-preoperative questionnaire as well as audio testing completed prior to surgery with followup done 24 hours postoperatively
|
|---|---|---|
|
Overall Study
Physician Decision
|
8
|
0
|
Baseline Characteristics
Severity Postoperative Pain Prediction
Baseline characteristics by cohort
| Measure |
1-elective Cesarean Sections
n=192 Participants
Elective Cesarean Sections-this portion completed
|
3-inpatient Gynecologic Procedures
n=100 Participants
Any in-patient gynecologic procedure- this portion completed
|
Total
n=292 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
|
192 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
292 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
|
30 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
44.5 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
34.95 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
192 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
292 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
44 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
140 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
220 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
192 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
292 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: evoked pain at 24 hoursPopulation: evoked pain outcome-measured on a scale of 0=no pain up to 100=most severe pain imaginable.
Outcome measure 0-100 Visual analog scale at 24 hours postoperatively, VAS of 0= no pain up to 100 =most severe pain
Outcome measures
| Measure |
1-elective Cesarean Section
n=192 Participants
Elective Cesarean Sections-evoked pain score at 24 hours postoperative 0-100mmVAS
|
3-inpatient Gynecologic Procedures
n=100 Participants
Any in-patient gynecologic procedure-
|
|---|---|---|
|
Evoked Pain at 24 Hours VAS
|
44 units on a scale
Standard Deviation 26
|
49.3 units on a scale
Standard Deviation 30.7
|
SECONDARY outcome
Timeframe: 24 hoursmeasured on a scale of 0-5, with 0=no anticipated pain medication needed up to 5 =most anticipated pain medication required
Outcome measures
| Measure |
1-elective Cesarean Section
n=192 Participants
Elective Cesarean Sections-evoked pain score at 24 hours postoperative 0-100mmVAS
|
3-inpatient Gynecologic Procedures
n=100 Participants
Any in-patient gynecologic procedure-
|
|---|---|---|
|
Anticipated Pain Medication Requirement
|
3 units on a scale
Interval 0.0 to 5.0
|
3 units on a scale
Interval 0.0 to 5.0
|
SECONDARY outcome
Timeframe: anticipated postoperative painanticipated postoperative pain on a scale of 0-100mm with 0=no anticipated pain at all up to 100= worst anticipated pain imaginable
Outcome measures
| Measure |
1-elective Cesarean Section
n=192 Participants
Elective Cesarean Sections-evoked pain score at 24 hours postoperative 0-100mmVAS
|
3-inpatient Gynecologic Procedures
n=100 Participants
Any in-patient gynecologic procedure-
|
|---|---|---|
|
Anticipated Postoperative Pain at Preoperative Evaluation
|
57 units on a scale
Standard Deviation 26
|
60.8 units on a scale
Standard Deviation 27.2
|
SECONDARY outcome
Timeframe: anticipated anxiety prior to surgerymeasure of anticipated anxiety for on a scale of 0-100, with 0= not anxious at all up to 100 = most anxious
Outcome measures
| Measure |
1-elective Cesarean Section
n=192 Participants
Elective Cesarean Sections-evoked pain score at 24 hours postoperative 0-100mmVAS
|
3-inpatient Gynecologic Procedures
n=100 Participants
Any in-patient gynecologic procedure-
|
|---|---|---|
|
Anxiety
|
52 units on a scale
Standard Deviation 32
|
57.5 units on a scale
Standard Deviation 34.8
|
Adverse Events
1-elective Cesarean Sections
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3-inpatient Gynecologic Procedures
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
Peter H. Pan MD, MSEE
Wake Forest School of Medicine-Anesthesiology
Phone: 336-718-8278
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place