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

NCT04797637 | Completed Results FDA Device

• 1 other identifier: 210266
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

cesarean; c-section; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Total Morphine Milliequivalent (MME) Use Postoperatively After Cesarean Delivery

  Postoperative analgesia will be administered to all participants as per routine guidelines on postpartum.

  14 days postoperative

Secondary Outcomes (5)

• 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

• Duration of 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

• Surgical Costs in Groups With and Without Patient Positioning Device

  Baseline to 14 days

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

The control group will have postoperative care per usual care

Interventions

ABBy® Adjustable Panniculus Retractor for Wound Care DEVICE

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.

Also known as: Abby device

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This is a obstetric study and only affects women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Cesarean delivery
• \<36 hours post-delivery

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• GSquared Medical, LLC: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (10)

• ACOG Committee Opinion No. 742: Postpartum Pain Management. Obstet Gynecol. 2018 Jul;132(1):e35-e43. doi: 10.1097/AOG.0000000000002683.

  PMID: 29781876 BACKGROUND

• Corso E, Hind D, Beever D, Fuller G, Wilson MJ, Wrench IJ, Chambers D. Enhanced recovery after elective caesarean: a rapid review of clinical protocols, and an umbrella review of systematic reviews. BMC Pregnancy Childbirth. 2017 Mar 20;17(1):91. doi: 10.1186/s12884-017-1265-0.

  PMID: 28320342 BACKGROUND

• Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.

  PMID: 18818022 BACKGROUND

• Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.

  PMID: 26827847 BACKGROUND

• Martin JA, Hamilton BE, Osterman MJK, Driscoll AK. Births: Final Data for 2018. Natl Vital Stat Rep. 2019 Nov;68(13):1-47.

  PMID: 32501202 BACKGROUND

• Stoker KC. Use of Abdominal Binders for Postoperative Pain After Gastrointestinal Surgery: An Integrative Review. J Perianesth Nurs. 2019 Aug;34(4):829-833. doi: 10.1016/j.jopan.2018.10.010. Epub 2019 Feb 7.

  PMID: 30745077 BACKGROUND

• Ossola P, Mascioli F, Coletta D, Pizzato M, Bononi M. Evidence on postoperative abdominal binding: A systematic review with meta-analysis of randomized controlled trials. Surgeon. 2021 Aug;19(4):244-251. doi: 10.1016/j.surge.2020.07.003. Epub 2020 Aug 6.

  PMID: 32773235 BACKGROUND

• Gillier CM, Sparks JR, Kriner R, Anasti JN. A randomized controlled trial of abdominal binders for the management of postoperative pain and distress after cesarean delivery. Int J Gynaecol Obstet. 2016 May;133(2):188-91. doi: 10.1016/j.ijgo.2015.08.026. Epub 2016 Jan 14.

  PMID: 26892694 BACKGROUND

• Gustafson JL, Dong F, Duong J, Kuhlmann ZC. Elastic Abdominal Binders Reduce Cesarean Pain Postoperatively: A Randomized Controlled Pilot Trial. Kans J Med. 2018 May 18;11(2):1-19. eCollection 2018 May.

  PMID: 29796155 BACKGROUND

• Zuckerwise LC, Mulhall JC, Thompson JL, Jackson LA, McNeill-Simaan EO, Osmundson SS. Effect of panniculus elevation device on postoperative pain after cesarean delivery: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 May;5(5):100920. doi: 10.1016/j.ajogmf.2023.100920. Epub 2023 Mar 6.

  PMID: 36889439 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Lisa C. Zukerwise, MD
• Organization: Vanderbilt University Medical Center

lisa.zuckerwise@vumc.org

9144203838

Study Officials

• Lisa Zuckerwise, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology

Model Details: 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.

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 15, 2021
• Study Start: April 1, 2021
• Primary Completion: July 20, 2022
• Study Completion: July 20, 2022
• Last Updated: August 22, 2023
• Results First Posted: January 6, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)