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Trial Outcomes & Findings for Do Elastic Abdominal Binders Reduce Post Operative Pain and Blood Loss? (NCT NCT01786330)

NCT ID: NCT01786330

Last Updated: 2016-04-11

Results Overview

SF-MPQ2 Pain assessment scale was used to measure lowest pain level postoperative. The pain assessment was self-administered. Lowest pain was reported using a 0 to 10 scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine." Lowest pain level is reported as means for each participant group.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

24 hours postoperative

Results posted on

2016-04-11

Participant Flow

There were 66 women assessed for eligibility. Of those women, six were excluded from the trial before being assigned to groups. Of the six women excluded: three presented to the hospital in labor prior to the scheduled cesarean, two reported for treatment for chronic pain, and one woman wanted the intervention regardless of randomization.

Participant milestones

Participant milestones
Measure
Intervention
Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery. Procare abdominal binder
Control
Group receives standard of care Standard of Care
Overall Study
STARTED
30
30
Overall Study
COMPLETED
29
27
Overall Study
NOT COMPLETED
1
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Intervention
Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery. Procare abdominal binder
Control
Group receives standard of care Standard of Care
Overall Study
Withdrawal by Subject
0
1
Overall Study
Lost to Follow-up
0
1
Overall Study
Excluded intraoperatively
0
1
Overall Study
Protocol Violation
1
0

Baseline Characteristics

Do Elastic Abdominal Binders Reduce Post Operative Pain and Blood Loss?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control
n=27 Participants
Group receives standard of care Standard of Care
Total
n=56 Participants
Total of all reporting groups
Intervention
n=29 Participants
Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery. Procare abdominal binder
Age, Continuous
27.7 years
STANDARD_DEVIATION 4.4 • n=7 Participants
28.1 years
STANDARD_DEVIATION 4.6 • n=5 Participants
28.5 years
STANDARD_DEVIATION 4.7 • n=5 Participants
Sex: Female, Male
Female
27 Participants
n=7 Participants
56 Participants
n=5 Participants
29 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
27 participants
n=7 Participants
56 participants
n=5 Participants
29 participants
n=5 Participants
Previous vaginal births
0 vaginal births
n=7 Participants
0 vaginal births
n=5 Participants
0 vaginal births
n=5 Participants
Previous cesarean deliveries
1 cesarean deliveries
n=7 Participants
1 cesarean deliveries
n=5 Participants
1 cesarean deliveries
n=5 Participants
Body mass index calculated during 1st visit
28.6 kg/m^2
STANDARD_DEVIATION 6.3 • n=7 Participants
28.7 kg/m^2
STANDARD_DEVIATION 6.4 • n=5 Participants
28.9 kg/m^2
STANDARD_DEVIATION 6.6 • n=5 Participants
Gestational age at cesarean delivery
39.3 weeks
STANDARD_DEVIATION 0.6 • n=7 Participants
39.2 weeks
STANDARD_DEVIATION 0.5 • n=5 Participants
39.1 weeks
STANDARD_DEVIATION 0.3 • n=5 Participants
Infant birth weight
3525.2 grams
STANDARD_DEVIATION 514.8 • n=7 Participants
3580.8 grams
STANDARD_DEVIATION 480.6 • n=5 Participants
3632.5 grams
STANDARD_DEVIATION 449.2 • n=5 Participants
Breech presentation
3 participants
n=7 Participants
6 participants
n=5 Participants
3 participants
n=5 Participants
Received epidural
27 participants
n=7 Participants
55 participants
n=5 Participants
28 participants
n=5 Participants
Received Duramorph
27 participants
n=7 Participants
56 participants
n=5 Participants
29 participants
n=5 Participants
Number of pads used during 24 hours postoperative
5.48 pads used
STANDARD_DEVIATION 1.95 • n=7 Participants
5.38 pads used
STANDARD_DEVIATION 2.1 • n=5 Participants
5.29 pads used
STANDARD_DEVIATION 2.27 • n=5 Participants

PRIMARY outcome

Timeframe: 24 hours postoperative

SF-MPQ2 Pain assessment scale was used to measure lowest pain level postoperative. The pain assessment was self-administered. Lowest pain was reported using a 0 to 10 scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine." Lowest pain level is reported as means for each participant group.

Outcome measures

Outcome measures
Measure
Intervention
n=29 Participants
Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery. Procare abdominal binder
Control
n=27 Participants
Group receives standard of care Standard of Care
Lowest Pain Level Postoperative
1.66 units on a scale
Standard Deviation 1.47
2.56 units on a scale
Standard Deviation 1.22

PRIMARY outcome

Timeframe: 24 hours postoperative

SF-MPQ2 Pain assessment scale was used to measure average pain level postoperative. The pain assessment was self-administered. Average pain was reported using a 0 to 10 scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine." Reported average pain level is reported as means for each participant group.

Outcome measures

Outcome measures
Measure
Intervention
n=29 Participants
Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery. Procare abdominal binder
Control
n=27 Participants
Group receives standard of care Standard of Care
Average Pain Level Postoperative
3.45 units on a scale
Standard Deviation 1.74
4.48 units on a scale
Standard Deviation 1.60

PRIMARY outcome

Timeframe: 24 hours postoperative

SF-MPQ2 Pain assessment scale was used to measure worst pain level postoperative. The pain assessment was self-administered. Worst pain was reported using a 0 to 10 scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine." Worst pain level is reported as means for each participant group.

Outcome measures

Outcome measures
Measure
Intervention
n=29 Participants
Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery. Procare abdominal binder
Control
n=27 Participants
Group receives standard of care Standard of Care
Worst Pain Level Postoperative
6.41 units on a scale
Standard Deviation 2.47
6.67 units on a scale
Standard Deviation 1.80

SECONDARY outcome

Timeframe: 24 hours from baseline

Hemoglobin concentration will be assessed 24 hours after surgery by assessing routine post-operative lab values. Outcome is reported as average difference between pre-operative hemoglobin concentration and post-operative hemoglobin concentration. The negative number indicates the drop in hemoglobin concentration postoperatively.

Outcome measures

Outcome measures
Measure
Intervention
n=29 Participants
Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery. Procare abdominal binder
Control
n=27 Participants
Group receives standard of care Standard of Care
Change in Hemoglobin Concentration
-1.84 g/dL
Standard Deviation 1.33
-1.43 g/dL
Standard Deviation 0.61

Adverse Events

Intervention

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Control

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

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Intervention
n=29 participants at risk
Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery. Procare abdominal binder
Control
n=27 participants at risk
Group receives standard of care Standard of Care
Skin and subcutaneous tissue disorders
Itching
6.9%
2/29 • Number of events 2
0.00%
0/27

Additional Information

Zachary Kuhlmann, DO

University of Kansas School of Medicine - Wichita

Phone: 316-685-7234

Results disclosure agreements

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