Transcutaneous Electrical Nerve Stimulation and Maternal Opioid Use After Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Post-operative Pain Ratings
研究概览
简要总结
We propose to explore the effects of Transcutaneous Electrical Nerve Stimulation (TENS) therapy in the pain management of postpartum women.
A. Objectives
- To determine if the addition of TENS therapy to the pain management of women post-cesarean section leads to less opioid medication use.
- To evaluate the efficacy of TENS therapy as a means of alternative pain relief for women post-cesarean section with a history of opioid use.
B. Hypotheses / Research Question(s) We hypothesize that patients that receive TENS therapy will report lower pain scores and request less opioid medication than the control group. We anticipate improved control in particular in the group of women with a history of opioid use.
Additionally, we believe that the TENS therapy will show benefits in other postpartum outcomes including time to bowel movement, level of sedation, and time to out of bed.
Overall, we anticipate that this pilot study will support the application of TENS therapy in postpartum pain management.
详细描述
OVERVIEW. This study is a pilot randomized interventional trial. Two categories of participants will be randomly assigned to an invention or control group, using a random number generator: normal cesarean without associated comorbidity, or cesarean in women with a history of opioid addiction. The control group will receive usual care. The intervention group will receive usual care plus TENS therapy beginning 8 hours after cesarean section and continuing to discharge. Both groups will receive medications for pain as requested or ordered by the doctor.
RESEARCH PROCEDURES. Patients will be identified for participation in their prenatal visit, and will be approached for study inclusion. Physicians that have a direct treatment relationship with the patient will inform the patient about the study and invite them to enroll. Consent for participation will be reviewed with the principal investigator and signed prior to delivery hospitalization. Randomization will follow consent, and patients randomized to intervention will have teaching performed about how to use the device at the time of consent.
Following cesarean delivery, subjects will be re-approached in the Postpartum Unit at Robert Wood Johnson University Hospital by study staff. The TENS device will be again reviewed, and provided to the patient, with review of instructions for use. The patients in the intervention group will be educated on the proper way to utilize the TENS unit. They will apply the the patches of the TENS unit around the C-section site. Starting 8 hours after C-Section, the TENS unit will be turned on and will remain on until the patient is discharged, to be removed for toilet and showering at the patient's discretion. Once the TENS unit is applied and turned on, the patient will not have to do anything else to maintain the therapy. Study staff will provide a record for documentation of time on/off for the unit. On the day of discharge, study staff will collect the device, and conduct a short survey about pain score. They will then review pain scores, pain medication usage and other secondary outcomes in the patient's chart. Finally, pain will be reassessed at the subject's outpatient postpartum visits by study staff.
DATA COLLECTION. Our research team members will collect the following data points from the patient's inpatient medical record: pain scale scores, medication requests/prescriptions (including name, type, and amount), time to first bowel movement, subjective incision complaints, and time to OOB. Participants will complete a survey before discharge which will solicit additional information about the postpartum recovery experience with or without TENS therapy.
DURATION OF STUDY. Study duration will be no more than 12 weeks. This will include up to 6 weeks prior to delivery for study approach and consent, delivery hospitalization, and 6 weeks postpartum for pain assessments at postpartum visits. There will be no long term follow up.
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
Not able to be masked
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged between 18 and 45 years
- •Understand and be able to follow written and oral instructions in English
- •Provide written informed consent
- •History of prior opioid addiction for half of the patients.
排除标准
- •History of cardiac arrhythmia or pacemaker usage
结局指标
主要结局
Post-operative Pain Ratings
时间窗: 3-4 post-operative days
Post-operative pain rating (0-10 scale) using Visual Analog Scale (VAS). VAS scores correspond self-report pain intensity. Higher scores mean higher pain intensity.
次要结局
- Milligrams Morphine Equivalent(3-4 post-operative days)
- Acetominophen Dosage(3-4 postoperative days)
- Ibuprofen Dosage(3-4 postoperative days)
- Time to OOB(3-4 post-operative days)
- Time to First BM(3-4 post-operative days)
- Level of Sedation(3-4 post-operative days)
- Number of Participants Who Found the Device Acceptable(3-4 days postoperatively)
- McGill Pain Questionnaire(6 weeks postoperatively)
- Neuropathic Pain Scale (NPS)(3-4 postoperative days)
- Acceptability Questionnaire(6 weeks postoperatively)
- Neuropathic Pain Scale(6 weeks postoperatively)
研究者
Adrienne Simonds PT PhD
Assistant Professor of Rehabilitation and Movement Sciences,
Rutgers, The State University of New Jersey