Do Elastic Abdominal Binders Reduce Post Operative Pain and Blood Loss?

This is a pilot study investigating the use of abdominal binders after cesarean sections. The researchers are testing whether elastic abdominal binders improve postoperative pain control and reduce postoperative blood loss. Blood loss and pain control are both concerns after giving birth. It is hoped that the use of an abdominal binder after giving birth will provide a non-pharmacologic way to to reduce blood loss and manage pain.

Study Overview

• Status: Completed
• Conditions: Pain; Postpartum Hemorrhage
• Intervention / Treatment: Other: Standard of Care; Device: Procare abdominal binder

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Wesley Medical Center
    • Wichita, Kansas, United States, 67214
      • Kansas School of Medicine-Wichita

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Cesarean section at term (at least 39 weeks gestation) scheduled in advance
• Singleton gestation confirmed by ultrasound in the current pregnancy
• Body mass index 20-40 kg/m2 (at first prenatal visit or pre-pregnancy)

• None of these pregnancy complications in the current pregnancy:

  1. bleeding disorder or use of anticoagulants other than low-dose heparin
  2. abnormal placenta (placenta previa or accrete)
  3. Preoperative hemoglobin less than 10 mg/dL
  4. Chorioamnionitis (intrauterine infection)
• No chronic pain syndrome (defined as participating in formal chronic pain management within the past year)
• Able to read English and understand spoken English

Exclusion Criteria:

• Onset of labor prior to time when the cesarean was scheduled

• Complications during performance of cesarean or discovered during cesarean:

  1. placenta accreta, increta, or percreta
  2. vasa previa
  3. cesarean hysterectomy required for severe hemorrhage
  4. organ damage during cesarean (cystotomy, enterotomy, ureteral injury)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.	Device: Procare abdominal binder
Active Comparator: Control; Group receives standard of care	Other: Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lowest Pain Level Postoperative	SF-MPQ2 Pain assessment scale was used to measure lowest pain level postoperative. The pain assessment was self-administered. Lowest pain was reported using a 0 to 10 scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine." Lowest pain level is reported as means for each participant group.	24 hours postoperative
Average Pain Level Postoperative	SF-MPQ2 Pain assessment scale was used to measure average pain level postoperative. The pain assessment was self-administered. Average pain was reported using a 0 to 10 scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine." Reported average pain level is reported as means for each participant group.	24 hours postoperative
Worst Pain Level Postoperative	SF-MPQ2 Pain assessment scale was used to measure worst pain level postoperative. The pain assessment was self-administered. Worst pain was reported using a 0 to 10 scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine." Worst pain level is reported as means for each participant group.	24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hemoglobin Concentration	Hemoglobin concentration will be assessed 24 hours after surgery by assessing routine post-operative lab values. Outcome is reported as average difference between pre-operative hemoglobin concentration and post-operative hemoglobin concentration. The negative number indicates the drop in hemoglobin concentration postoperatively.	24 hours from baseline

Collaborators and Investigators

• Sponsor: Zachary Kuhlmann, DO
• Investigators: Principal Investigator: Zachary Kuhlmann, DO, University of Kansas Medical Center

Publications and helpful links

General Publications

• Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: February 5, 2013
• First Submitted That Met QC Criteria: February 5, 2013
• First Posted (Estimate): February 7, 2013

Study Record Updates

• Last Update Posted (Estimate): April 11, 2016
• Last Update Submitted That Met QC Criteria: March 10, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Pain, Postoperative; Hemorrhage; Postpartum Hemorrhage
• Other Study ID Numbers: 220121565; 12-049