Clinical trial NCT03843788: TENS and Opioid Use After Cesarean Delivery
Official title: Transcutaneous Electrical Nerve Stimulation and Maternal Opioid Use After Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cesarean Section Complications
Opioid Use
Keywords: Post-cesarean pain
Transcutaneous Electrical Nerve Stimulation
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2019-02-18
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a pilot feasibility study to evaluate effectiveness and acceptability in our patient population of TENS use throughout delivery hospitalization. We aim to have 20 participants total: 5 in control and 5 in intervention without history of opioid addiction, and 5 in control and 5 in intervention with history of opioid addiction/misuse. This sample size is comparable to other shorter term pilot studies. This pilot study will serve as the basis for larger trials in the future, with larger sample size powered to demonstrate reduction in pain scores. We anticipate recruitment for this trial will take approximately 6-9 months.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

PRIMARY and SECONDARY ENDPOINTS. Primary endpoint of this pilot study is a total of 10 normal patients undergoing cesarean, and 10 patients with history of opioid addiction. Intervention will be performed in 5 patients in each group. Safety data will be reviewed following the first 10 patients to evaluate for worsening patient scores relative to controls.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

- History of cardiac arrhythmia or pacemaker usage

Primary outcomes:
measure: Post-operative Pain Ratings
timeFrame: 3-4 post-operative days
Secondary outcomes:
measure: Milligrams Morphine Equivalent
timeFrame: 3-4 post-operative days
measure: Acetominophen Dosage
timeFrame: 3-4 postoperative days
measure: Ibuprofen Dosage
timeFrame: 3-4 postoperative days
measure: Time to OOB
timeFrame: 3-4 post-operative days
measure: Time to First BM
timeFrame: 3-4 post-operative days
measure: Level of Sedation
timeFrame: 3-4 post-operative days
measure: Number of Participants Who Found the Device Acceptable
timeFrame: 3-4 days postoperatively
measure: McGill Pain Questionnaire
timeFrame: 3-4 days postoperatively
measure: Neuropathic Pain Scale (NPS)
timeFrame: 3-4 postoperative days
measure: Acceptability Questionnaire
timeFrame: 6 weeks postoperatively
measure: McGill Pain Questionnaire
timeFrame: 6 weeks postoperatively
measure: Neuropathic Pain Scale
timeFrame: 6 weeks postoperatively
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
Study officials:
affiliation: Rutgers School of Health Professions
name: Adrienne Simonds, PT PhD
role: PRINCIPAL_INVESTIGATOR
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