Post-operative Patient Positioning Device for Improvement of Post-Operative Pain in Parturients Undergoing Cesarean Delivery: A Randomized Controlled Trial
Phase: NA
Conditions: Pain, Postoperative
Sponsor: Vanderbilt University Medical Center

 
Protocol Version #: 
 
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Protocol Date: 12-16-2020 
 
 
 
 
 
 
 
 
Postoperative patient positioning device for improvement of postoperative 
pain in parturients undergoing cesarean delivery: a randomized controlled 
trial 
 
Lisa C. Zuckerwise 
Obstetrics and Gynecology 
 
 
 
 
 
 
 
 
 
 
 
 
 
Joseph Connor Mulhall, MD 
Jennifer L. Thompson, MD 
Sarah S. Osmundson, MD, MS 
Edwina McNeill-Simaan, MS 
Obstetrics and Gynecology 
 
 
 
 
 
 
Table of Contents: 
 
Study Schema 
1.0 
Background 
2.0 
Rationale and Specific Aims 
3.0 
Animal Studies and Previous Human Studies 
4.0 
Inclusion/Exclusion Criteria 

 
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5.0 
Enrollment/Randomization 
6.0 
Study Procedures 
7.0 
Risks of Investigational Agents/Devices (side effects) 
8.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk to 
Participants or Others 
9.0 
Study Withdrawal/Discontinuation 
10.0 
Statistical Considerations 
11.0 
Privacy/Confidentiality Issues 
12.0 
Follow-up and Record Retention 
 

 
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1.0 
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 1, 2. Untreated pain is 
associated with persistent pain, postpartum depression, and greater opioid use3.  
 
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 consumption4. 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 19965. 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 literature6, 7. Ossala et al (2020) published a recent meta-
analysis of five randomized control trials evaluating the effectiveness of abdominal 
binders on postoperative pain following midline laparotomy. Their analysis showed 
significant reduction in postoperative pain on post-op days 1 and 5, though only one of 
the studies analyzes was from the United States, and the mean patient age was 61 
years old7.  
 
The utility of abdominal support within the Obstetrics literature is both sparse and 
conflicting. Gillier et al (2016) published the first randomized control trial in the United 
States studying the use of abdominal binders following antepartum and intrapartum 
cesarean sections performed via Pfannenstiel incisions. In their study population of 155 
women (87 binder vs 68 control), they found no difference in postoperative pain scores 
on postop days 1 and 28. Gustafson et al (2018) performed a similar, though smaller, 
study of 56 patients (29 binder vs 27 control), and did report statistically significant lower 
pain scores in the abdominal binder group (p= 0.019)9. Of note, these two studies used 
different metrics to quantify postoperative pain. Neither of these two studies followed 
patients after hospital discharge, nor did they report on other postoperative 
complications including venous thromboembolisms or surgical site infections8, 9.  
 
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, 

 
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pain medication requirement, and patient satisfaction, when used as a patient-
positioning device in women following cesarean delivery. 
 
 
2.0 
Rationale and Specific Aims 
 
Primary Objective:   To compare the effects of post-operative patient positioning device, 
the ABBy, to standard wound dressings on postoperative pain in parturients delivered by 
cesarean delivery. 
 
Primary Outcome: Postoperative opioid use post cesarean delivery 
 
Secondary Objectives:   
• 
To evaluate subjective pain scores, patient satisfaction, and duration of use of 
patient positioning device. 
• 
To evaluate surgical complication and costs in groups with and without patient 
positioning device 
 
3.0 
Animal Studies and Previous Human Studies 
 
The utility of abdominal support within the Obstetrics literature is both sparse and 
conflicting. Gillier et al (2016) published the first randomized control trial in the United 
States studying the use of abdominal binders following antepartum and intrapartum 
cesarean sections performed via Pfannenstiel incisions. In their study population of 155 
women (87 binder vs 68 control), they found no difference in postoperative pain scores 
on postop days 1 and 28. Gustafson et al (2018) performed a similar, though smaller, 
study of 56 patients (29 binder vs 27 control) and did report statistically significant lower 
pain scores in the abdominal binder group (p= 0.019)9. Of note, these two studies used 
different metrics to quantify postoperative pain. Neither of these two studies followed 
patients after hospital discharge, nor did they report on other postoperative 
complications including venous thromboembolisms or surgical site infections8, 9.  
 
4.0 
Patient Population and Eligibility 
 
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 
 
 

 
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5.0 
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.   
 
6.0 
Study Procedures 
 
Methods: 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. 
 
 
7.0 
Risks 
 

 
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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. 
 
8.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk to 
Participants or Others 
 
Any adverse events will be reported to the Institutional Review Board in a timely manner 
as appropriate. 
 
9.0 
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.   
 
10.0 
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.  
 
11.0 
Privacy/Confidentiality Issues 
 
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. 
 
12.0 
Follow-up and 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.  
 
 
References:  

 
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1. Postpartum pain management. ACOG Committee Opinion No. 742. American College of 
Obstetricians and Gynecologists. Obstet Gynecol 2018;132. DOI: 
10.1097/AOG.0000000000002683. Epub 2018 May 18. 
2. Corso, Ellena et al. “Enhanced recovery after elective caesarean: a rapid review of 
clinical protocols, and an umbrella review of systematic reviews.” BMC pregnancy and 
childbirth vol. 17,1 91. 20 Mar. 2017, doi:10.1186/s12884-017-1265-0 
3. Eisenach, James C et al. “Severity of acute pain after childbirth, but not type of delivery, 
predicts persistent pain and postpartum depression.” Pain vol. 140,1 (2008): 87-94. 
doi:10.1016/j.pain.2008.07.011 
4. Chou R., Gordon D.B., de Leon-Casasola O.A., et. al.: 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; 17: pp. 131-157. 
5. National Vital Statistics Reports, Volume 68, Number 13, November 30 2019, Births: 
Final Data for 2018. https://www.cdc.gov/nchs/data/nvsr/nvsr68/nvsr68_13-508.pdf 
6. Stoker, Kelsey Carter. “Use of Abdominal Binders for Postoperative Pain After 
Gastrointestinal Surgery: An Integrative Review.” Journal of PeriAnesthesia Nursing, vol. 
34, no. 4, 7 Feb. 2019, pp. 829–833., doi:10.1016/j.jopan.2018.10.010.  
7. Ossola, Paolo, et al. “Evidence on Postoperative Abdominal Binding: A Systematic 
Review with Meta-Analysis of Randomized Controlled Trials.” The Surgeon, 6 Aug. 2020, 
doi:10.1016/j.surge.2020.07.003.  
8. 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;133(2):188–191. 
9. Gustafson, Jamie L et al. “Elastic Abdominal Binders Reduce Cesarean Pain 
Postoperatively: A Randomized Controlled Pilot Trial.” Kansas journal of medicine vol. 
11,2 1-19. 18 May. 2018