Post-operative Patient Positioning Device for Improvement of Post-Operative Pain

August 21, 2023 updated by: Lisa C. Zuckerwise, MD, Vanderbilt University Medical Center

Post-operative Patient Positioning Device for Improvement of Post-Operative Pain in Parturients Undergoing Cesarean Delivery: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

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.

ENROLLMENT/RANDOMIZATION:

All residents and Labor and Delivery staff will be apprised of the study and appropriate patients with either planned cesarean delivery or those delivered by cesarean delivery within 36 hours will have the opportunity to participate in the trial. The research team will use a daily list of all cesarean deliveries in Epic to identify potentially eligible patients for enrollment. Prior to contacting the patient, the research team member will check with the patient's nurse or care team to discuss eligibility and appropriateness for the study. Notices will also be placed in Labor and Delivery regarding the study. Study personnel will explain the study to the patient and allow ample time for the subject to ask questions related to the study. If the subject consents, she will sign the informed consent document and will be provided with a copy of the consent form prior to randomization.

Patients will be enrolled either during their delivery admission up until 36 hours after delivery. After enrolling, randomization will be performed on the obstetric unit within the first 36 hours postpartum. Participants will be randomized in a 1:1 ratio using permutated blocks of 6. REDCap will be used for randomization, using an uploaded randomization sequence. A member of the study team will access REDCap to complete randomization. The randomization result will be notated with the patient's study number and retained in the research record.

STUDY PROCEDURES:

Patients who meet inclusion criteria and undergo cesarean delivery at Vanderbilt University Hospital center will be asked to participate. Informed consent will be obtained during the delivery admission. Enrolled patients will be randomized within the first 36 hours following cesarean delivery. The 36-hour window for randomization will begin at the completion of surgical case, as marked in the Anesthetic Care Record in the EMR.

Patients randomized to the treatment group will have the ABBy device applied by study personnel at the time of randomization, followed by continuation of usual postoperative care. The control group will have postoperative care per usual care.

Cesarean delivery will be performed by patients' surgical team, with surgical technique per surgeon preference. Women in the treatment group will have the ABBy device placed above the incision within 36 hours of cesarean delivery completion. All team members placing the ABBy device will undergo training and demonstrate competence.

Postoperative analgesia will be administered to all participants as per routine guidelines on postpartum. All study patients will receive an electronic survey at 10 days postoperatively and again at 14 days for those continuing to use the ABBy device or opioid medication at the 10-day survey.

Specific medical information regarding pregnancy and delivery will be collected and analyzed from the patients' electronic medical records.

RISKS:

A rare risk exists if the patient has an unknown allergy to the adhesive material in the device, though this is estimated at less than one per one million for the silicone-based adhesive used, and per the manufacturer's report, the raw materials used in the silicone roll stock construction (PS-1860) have been analyzed for biocompatibility and found to not cause any adverse effect when used properly (Polymer Science, Monticello, IN).

There is a risk of confidentiality breech in the collection of medical information. All efforts will be made to protect the personal information of the patient by the use of study number assignment and a password-protected database. Any breech in confidentiality will be promptly reported to the Vanderbilt IRB.

Any adverse events will be reported to the Institutional Review Board in a timely manner as appropriate.

STUDY WITHDRAWAL/DISCONTINUATION:

Any patient who wishes to withdraw from the study will be allowed to withdraw. Should the patient decide to withdraw from the study, she will notify the principal investigator and her information will be deleted from the study records.

STATISTICAL CONSIDERATIONS:

Sample size: To detect a reduction in pain medication use of 40% using an alpha of 0.05 and a beta of 0.20, 108 patients per group with a total sample of 216 patients will be required. The labor and delivery unit performs about 1400 cesarean deliveries annually; therefore, assuming an 80% eligibility rate and subsequent 50% participation rate, the study would be conducted over a 12-month period.

PRIVACY/CONFIDENTIALITY:

Risks to participants are minimized by limiting this prospective study to subjects meeting the inclusion/exclusion criteria. Access to PHI will be limited to the PI and co-investigators. All patients will be de-identified by assignment of a study number. All data collected in this study will be kept electronically in a secure REDCap database. The primary risk in this study involves the disclosure of protected health information. This risk is reasonable, given the above precautions, in relation to the potential benefit to both future patients and society in general by the possibility of reducing the use of pain medication in cesarean patients.

FOLLOW-UP/RECORD RETENTION:

The study will require 1 year for complete enrollment. Participants will be actively enrolled in the study for the duration of their or delivery admission plus up to 14 days follow-up time. Research records will be retained for up to 6 years.

Study Type

Interventional

Enrollment (Actual)

278

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age > 18 years
  2. Cesarean delivery
  3. <36 hours post-delivery

Exclusion Criteria:

  1. Vertical skin incision
  2. Inability to place device superior to incision
  3. Presence of surgical drain
  4. Opioid use disorder
  5. Chronic opioid use (> 14 consecutive days during pregnancy)
  6. Allergy to device adhesive
  7. Active COVID-19 infection
  8. Patient unable to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: ABBy® Adjustable Panniculus Retractor for Wound Care
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.
Other Names:
  • Abby device
No Intervention: Standard of Care
The control group will have postoperative care per usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 days postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Pain Scores During Use of Patient Positioning Device
Time Frame: Baseline to 14 days postoperative

Postoperative analgesia will be administered to all participants as per routine guidelines on postpartum. All study patients will receive an electronic survey at 10 days postoperatively and again at 14 days for those continuing to use the ABBy device or opioid medication at the 10-day survey.

Subjective pain scores (zero to 100 sliding scale) Please provide a number that best describes pain you have experienced at its WORST since discharge? No pain (0) worst pain imaginable (100) Please provide a number that best describes the AVERAGE pain you have experienced since discharge? No pain (0) worst pain imaginable (100)
Baseline to 14 days postoperative
Patient Satisfaction During Use of Patient Positioning Device.
Time Frame: Baseline to 14 days postoperative

Postoperative analgesia will be administered to all participants as per routine guidelines on postpartum. All study patients will receive an electronic survey at 10 days postoperatively and again at 14 days for those continuing to use the ABBy device or opioid medication at the 10-day survey.

Patient satisfaction with device

Question as part of a survey to patients who had the ABBy device placed:

I would use ABBy next time (strongly agree, agree, neutral, disagree, strongly disagree)
Baseline to 14 days postoperative
Duration of Use of Patient Positioning Device.
Time Frame: Baseline to 14 days postoperative

Postoperative analgesia will be administered to all participants as per routine guidelines on postpartum. All study patients will receive an electronic survey at 10 days postoperatively and again at 14 days for those continuing to use the ABBy device or opioid medication at the 10-day survey.

Duration of use of patient positioning device Question on survey: How long did you use the ABBy? (please enter a number of days, counting from the day placed as zero)
Baseline to 14 days postoperative
Number of Participants With Surgical Complications in Groups With and Without Patient Positioning Device
Time Frame: Baseline to 14 days
Specific medical information regarding pregnancy and delivery will be collected and analyzed from the patients' electronic medical records.
Baseline to 14 days
Surgical Costs in Groups With and Without Patient Positioning Device
Time Frame: Baseline to 14 days
Additional costs resulting from surgical complications.
Baseline to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Collaborators

GSquared Medical, LLC

Investigators

  • Principal Investigator: Lisa Zuckerwise, MD, Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

July 20, 2022

Study Completion (Actual)

July 20, 2022

Study Registration Dates

First Submitted

March 9, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (Actual)

March 15, 2021

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 21, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 210266

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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