Post-operative Patient Positioning Device for Improvement of Post-Operative Pain in Parturients Undergoing Cesarean Delivery: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 278
- Locations
- 1
- Primary Endpoint
- Total Morphine Milliequivalent (MME) Use Postoperatively After Cesarean Delivery
Study Overview
Brief 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.
Detailed Description
BACKGROUND:
Postoperative pain has significant short- and long-term implications for parturients undergoing cesarean delivery. Poorly controlled postoperative pain can interfere with the women's ability to care for herself and her newborn in the immediate postoperative period, and can contribute to longer length of hospitalizations. Untreated pain is associated with persistent pain, postpartum depression, and greater opioid use.
It is well established that an individualized, multimodal analgesic plan for the management of postoperative pain following cesarean delivery is associated with superior pain relief and decreased opioid consumption. While different institutional guidelines influence general practice patterns, a combination of several medications acting on different receptors has been shown to be effective in decreasing postoperative pain. In 2018, the cesarean section rate in the United States was 31.9%, compared to 20.7% in 1996. As the cesarean delivery rate increases, it is becoming more pertinent to develop and incorporate nonpharmacologic practices for postoperative pain.
The use of abdominal binders as an adjunct to pharmacologic therapy for the management of postoperative pain following major abdominal surgery has previously been discussed in surgical literature.
The utility of abdominal support within the Obstetrics literature is both sparse and conflicting.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age > 18 years
- •Cesarean delivery
- •<36 hours post-delivery
Exclusion Criteria
- •Vertical skin incision
- •Inability to place device superior to incision
- •Presence of surgical drain
- •Opioid use disorder
- •Chronic opioid use (> 14 consecutive days during pregnancy)
- •Allergy to device adhesive
- •Active COVID-19 infection
- •Patient unable to consent
Arms & Interventions
Treatment Group
Patients randomized to the treatment group will have the ABBy device applied by study personnel at the time of randomization, followed by a continuation of usual postoperative care.
Intervention: ABBy® Adjustable Panniculus Retractor for Wound Care (Device)
Standard of Care
The control group will have postoperative care per usual care
Outcomes
Primary Outcomes
Total Morphine Milliequivalent (MME) Use Postoperatively After Cesarean Delivery
Time Frame: 14 days postoperative
Postoperative analgesia will be administered to all participants as per routine guidelines on postpartum.
Secondary Outcomes
- Duration of Use of Patient Positioning Device.(Baseline to 14 days postoperative)
- Surgical Costs in Groups With and Without Patient Positioning Device(Baseline to 14 days)
- Subjective Pain Scores During Use of Patient Positioning Device(Baseline to 14 days postoperative)
- Patient Satisfaction During Use of Patient Positioning Device.(Baseline to 14 days postoperative)
- Number of Participants With Surgical Complications in Groups With and Without Patient Positioning Device(Baseline to 14 days)
Investigators
Lisa C. Zuckerwise, MD
Assistant Professor of Obstetrics and Gynecology
Vanderbilt University Medical Center