N/A
N=278
Post-operative Patient Positioning Device for Improvement of Post-Operative Pain
Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT04797637 ↗Enrolled (actual)
278
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Total Morphine Milliequivalent (MME) Use Postoperatively After Cesarean Delivery — 52; 68 Morphine milligram equivalents
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ABBy® Adjustable Panniculus Retractor for Wound Care (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Morphine Milliequivalent (MME) Use Postoperatively After Cesarean Delivery |
52; 68 | — |
| SECONDARY Subjective Pain Scores During Use of Patient Positioning Device |
50; 51; 25; 30 | — |
| SECONDARY Patient Satisfaction During Use of Patient Positioning Device. |
30; 33; 24; 12; 1 | — |
| SECONDARY Duration of Use of Patient Positioning Device. |
5 | — |
| SECONDARY Number of Participants With Surgical Complications in Groups With and Without Patient Positioning Device |
1; 1; 2; 0; 0; 0 | — |
| SECONDARY Surgical Costs in Groups With and Without Patient Positioning Device |
— | — |
Summary
This paucity of evidence supporting or dissuading the use of postoperative abdominal support following cesarean section for the reduction of postoperative pain leaves important clinical questions unanswered. Additionally, there is an absence of long-term outcomes associated with the use of abdominal support devices. There remains a need for the development and implementation of nonpharmacologic methods for analgesia for women following cesarean sections, along with evidence-based recommendations regarding their use in postoperative patients. The ABBy (G-Squared Medical, Brentwood, TN) is an extended-wear panniculus retractor/tissue stabilizer that is intended for use postoperatively after abdominal procedure.
It is placed directly onto patient skin, superior to a transverse incision, and is then used to elevate redundant tissues away from an incision or wound (https://www.gsquaredmedical.com/How-it-Works.html). The ABBy can be removed and replaced by patients and can be used for up to 10 days. This study aims to assess the effect of ABBy use on postoperative pain, pain medication requirement, and patient satisfaction, when used as a patient-positioning device in women following cesarean delivery.
Eligibility Criteria
Inclusion Criteria
- Age > 18 years
- Cesarean delivery
- 14 consecutive days during pregnancy)
- Allergy to device adhesive
- Active COVID-19 infection
- Patient unable to consent
Data sourced from ClinicalTrials.gov (NCT04797637). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.