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Post-partum Non-pharmacologic Pain Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03903172
Recruitment Status : Enrolling by invitation
First Posted : April 4, 2019
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Sheela Barhan, Wright State University

Tracking Information
First Submitted Date  ICMJE March 15, 2019
First Posted Date  ICMJE April 4, 2019
Last Update Posted Date August 25, 2020
Actual Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2019)
  • Patient reported average pain score [ Time Frame: Average score computed from Immediately postpartum, postpartum day 0, postpartum day 1 ]
    Pain score (standard scale is 1 - no pain to 10- severe pain) will be recorded by nursing staff in electronic medical record per standard of care. Average pain score for postpartum day 0 and postpartum day 1 will be computed. High scores represent greater pain.
  • Total non-narcotic pain medication use [ Time Frame: Total non-narcotic medication use from sum of postpartum day 0 and postpartum day 1 ]
    Total non-narcotic pain medication use recorded on MAR for postpartum day 0 and postpartum day 1
  • Total narcotic pain medication use [ Time Frame: Total narcotic medication use from sum of postpartum day 0 and postpartum day 1 ]
    Total narcotic pain medication use (in morphine equivalents) as recorded on MAR for postpartum day 0 and postpartum day 1
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post-partum Non-pharmacologic Pain Management
Official Title  ICMJE Post-partum Non-pharmacologic Pain Management
Brief Summary This study aims to examine whether use of an abdominal binder for postpartum patients after vaginal delivery can effectively manage their pain and reduce the need for pharmacologic analgesics. The investigators hypothesize that use of an abdominal binder will decrease patient pain as reported on a visual analog scale of one to ten, and will decrease quantity of pain medications given. The study will be conducted at the Berry Women's Center at Miami Valley Hospital. Potential eligible participants will be approached regarding the study on admission to labor and delivery. The investigators will recruit 130 participants that will be randomized to two study arms, standard care and standard care plus abdominal binder with 65 participants in each study arm. Data will be collected prospectively while participants are admitted, and through review of electronic medical records. Potential benefits of this study include investigation of a cost-effective method for pain management that could improve patient comfort and reduce need for medications.
Detailed Description

Hypothesis Use of an abdominal binder postpartum after a vaginal delivery will be associated with lower pain scores and reduced need for pharmacologic analgesics.

Background A significant part of postpartum care involves management of patients' pain and discomfort. Etiologies of this pain include perineal pain, incisional pain, uterine involution pain, and pelvic girdle and lower back pain. Postpartum pain management primarily focuses on the former three types of pain: perineal, incisional and uterine involution. In a review of the management of postpartum pain, Eshkevari et al discuss several well-established pain management strategies employed for postpartum patients, including ibuprofen and other NSAIDs for uterine involution pain and inflammation; local anesthetics for perineal lacerations or episiotomies; warm or cold compresses for perineal pain; and opioids for post-operative or poorly controlled postpartum pain.

Data regarding management of pelvic girdle and lower back pain is scarce and the limited literature available primarily focus on the pregnant patient. Different proposed treatment or management strategies during pregnancy include physical therapy, targeted exercises, acupuncture, NSAIDS and opioids. Approximately 25% of postpartum women endorse pelvic girdle and/or lower back pain, and these types of pain can persist for as long as several weeks to 1-2 years after delivery. Therefore, management remains key for the postpartum patient as well. The proposed pathophysiology behind pelvic girdle pain and lower back pain in the context of pregnancy is widening of the pubic symphysis and increased laxity in the sacro-iliac joints (SIJ) secondary to both biomechanical shear forces of increased weight bearing and elevated levels of relaxin, a polypeptide hormone that increase laxity of ligaments. A prospective study investigating the impact of abdomino-pelvic belts at different positions on the laxity of the SIJ found that use of the abdomino-pelvic belt significantly decreased mobility of the SIJ. Additionally, pelvic belts or abdominal binders may help provide stability to muscles of the abdomen, back and spine.

Studies investigating the use of abdominal binders for pain management in post-operative patients following both cesarean section and gynecologic surgery have had mixed results. A randomized control trial examining impact of abdominal binders on patient reported pain and symptom distress found no significant difference in pain on post-operative days one and two, and the difference in distress on post-operative day two was no longer statistically significant after correction for multiple measures. Another study involving gynecologic surgery patients randomized to abdominal binder or control groups found that there was no overall significant difference in morphine use or pain scale between the groups, and the benefits were limited to a significant effect on post-operative ambulation for a subset of patients with highest risk of complications: patients > 50 years, cancer patients, and those with vertical incision. In contrast, a more recent randomized controlled trial assessing abdominal binders following cesarean delivery found that pain and symptom distress scores were significantly lower at all time points in comparison to a control group.

A common theme in the current literature regarding postpartum pain management is the need for more research. In light of the current opioid abuse epidemic, which affects approximately 2.1 million people and the U.S Department of Health and Human Services declared a public health emergency in 2017, there is a renewed emphasis utilizing non-opioid methods on pain control. As a primary source of pain in the postpartum period is associated with musculoskeletal pelvic discomfort, the use of a supportive abdomino-pelvic belt may be a non-pharmacologic modality that could reduce pain and decrease narcotic requirements in postpartum patients. No studies have directly assessed the effectiveness of abdominal binders on pain management in postpartum patients. This study aims to examine how use of an abdominal binder might impact postpartum pain, and the use of pharmacologic analgesia following vaginal delivery.

Protocol

  • Recruitment

    o Patients admitted to Labor and Delivery will be evaluated for potential participation in the study based on the inclusion and exclusion criteria outlined below. If appropriate to approach, eligible potential participants will be approached in their labor and delivery room prior to delivery. If interested in participation, the Informed Consent document will be presented and explained in the room to ensure privacy.

  • Subject Informed Consent

    • Informed consent process will take place at the Berry Women's Center at Miami Valley Hospital
    • Written and signed consent will be obtained in English.
  • Plans of obtaining informed consent:

    o Potential eligible participants will be approached in the labor and delivery room to ensure privacy. The research assistant will provide and discuss an informed consent form with the participant. The informed consent form will describe the project goals, length and rational, as well as the types of PHI that will be collected. All participants who agree to participate in the study will sign the informed consent form. All participants will be provided with a copy of the signed consent form.

  • Study design and procedures

    • After signing informed consent, participants will be assigned to the intervention or control group via block randomization
    • Those participants in the standard of care group will receive routine postpartum care
    • Those participants in the intervention group will receive an abdominal binder in addition to routine postpartum care
    • Determination of appropriate binder size will be based on a visual assessment of the patient's abdominal circumference
    • Nursing staff will evaluate participant's pain level using a visual analog scale of 1-10 a minimum of every 4 hours. Patient reported pain score and pain location will be recorded in the participant's electronic medical record. These processes do not deviate from current standards of care and documentation.
    • Additional non-pharmacologic pain relief measures utilized by patients will be documented on the data collection sheet attached to the patient's chart. These measures include heating pad, ice pack, and tucks pads
    • All medications received will be documented in the electronic medical record per usual documentation protocols
  • Sample Size Estimation & Data Analysis Plan

    • Sample size was estimated using G*Power. In order to detect a difference between groups on pain scores and use of pain medications, 65 patients per group will need to be enrolled. This will enable the investigators to detect a moderate difference (i.e., medium effect size) between the groups with a power = 80% and p at <0.05.
    • The two groups will be compared for 1. reported pain scores (assessed by nursing staff and documented in the EMR) and for 2. pain medications used (morphine equivalent as recorded in the MAR) for the duration of patients' hospital stay. T-test will be used to compare the groups on average pain scores and total pain medication use. Repeated measures analysis of variance will be used to determine differences between the groups over time.
  • Data collection plan

    • Prospective data collection with hard copy data entry form that includes PHI for participant identification, basic demographic information, delivery information (see separate document), non-pharmacologic pain relief measures used
    • Electronic medical record review for: pain scores, pain location, medications received
    • Pain score immediately postpartum
    • Pain scores (average scores) on PPD#0 and PPD#1
    • Patient reported pain locations
    • Quantity (total) of non-narcotic pain medication received on PPD#0 and PPD#1
    • Quantity (total) of narcotic pain medication received on PPD#0 and PPD#1
  • Risks

    • Allergic reaction to fabric of abdominal binder
    • Skin irritation
    • Increased discomfort or pain with use of abdominal binder
  • Mitigation of risks o If participants experience an allergic reaction or skin irritation from the abdominal binder symptomatic treatment will be offered. Participants in the experimental arm will be encouraged to keep the abdominal binders in place for 24 hours postpartum, but will be permitted to remove the abdominal binder at any time should it cause irritation, increased pain or any other adverse reaction.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Non-blinded, parallel group
Masking: None (Open Label)
Masking Description:
Open label
Primary Purpose: Treatment
Condition  ICMJE
  • Pain Management
  • Vaginal Delivery
Intervention  ICMJE Device: Abdominal binder
Abdominal binder
Study Arms  ICMJE
  • Experimental: Binder Arm
    Abdominal binder + standard of care postpartum pain management
    Intervention: Device: Abdominal binder
  • No Intervention: Standard of Care
    Standard of care postpartum pain managment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: April 2, 2019)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years of age and older
  • Pregnant
  • Admitted to labor and delivery
  • Anticipated spontaneous vaginal delivery
  • Informed consent obtained

Exclusion Criteria:

  • Documented chronic pain condition
  • Chronic narcotic use or Maternal Abstinence Treatment
  • UDS positive for opiates on admission
  • Trial of labor after cesarean
  • Lack of sufficient English proficiency to obtain informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Pregnant women will be enrolled
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03903172
Other Study ID Numbers  ICMJE Barhan-Wysong-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Data will be shard on a case by case basis.
Responsible Party Sheela Barhan, Wright State University
Study Sponsor  ICMJE Wright State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sheela Barhan, MD Wright State University
PRS Account Wright State University
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP