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

Zachary Kuhlmann, DO60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Postpartum Hemorrhage Pain

Interventions

Procare abdominal binderDEVICE

Standard of CareOTHER

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 39 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (2)

Kansas School of Medicine-Wichita

Wichita, Kansas, United States

Wesley Medical Center

Wichita, Kansas, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 24 hours postoperative

Secondary Outcomes

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.

Time frame: 24 hours from baseline

Data from ClinicalTrials.gov

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