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临床试验/NCT03903172
NCT03903172已完成不适用

Post-partum Non-pharmacologic Pain Management

Wright State University2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
105
试验地点
2
主要终点
Any Narcotic Pain Medication Use

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

Open label

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Any Narcotic Pain Medication Use

时间窗: Any narcotic medication use from postpartum day 0 and postpartum day 1

Any narcotic pain medication use (yes/no) as recorded on MAR for postpartum day 0 and postpartum day 1

Number of Patient Using Each Type of Non-narcotic Pain Medications

时间窗: Number of patients using each type of non-narcotic medication recorded on postpartum day 0 and postpartum day 1

Number of patients using each type of non-narcotic pain medication as recorded on MAR for postpartum day 0 and postpartum day 1

Patient Reported Average Pain Score

时间窗: Average score computed from postpartum day 0, postpartum day 1

Pain score (standard scale is 0 - 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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