TENS and Opioid Use After Cesarean Delivery

Not Applicable

Terminated

Conditions: Cesarean Section Complications
Opioid Use

Interventions: Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Registration Number: NCT03843788

Lead Sponsor: Rutgers, The State University of New Jersey

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 16

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post-CS TENS	Transcutaneous Electrical Nerve Stimulation (TENS)	The patients in the intervention group will be educated on the proper way to utilize the transcutaneous electrical nerve stimulation (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. Routine pharmacologic care will also be available.
Opioid Addicted Post-CS TENS	Transcutaneous Electrical Nerve Stimulation (TENS)	Subjects will be targeted on the basis of opioid addiction and usage of methadone maintenance. The patients in the intervention group will be educated on the proper way to utilize the transcutaneous electrical nerve stimulation (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. Routine pharmacologic care will also be available.

Primary Outcome Measures

Name	Time	Method
Post-operative Pain Ratings	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.

Secondary Outcome Measures

Name	Time	Method
Milligrams Morphine Equivalent	3-4 post-operative days	Milligrams morphine equivalent (MME) is a standardized method of totaling dose of opioid medication. MME uses a conversion factor to convert opioid medication dosages into morphine equivalents, in milligrams.
Acetominophen Dosage	3-4 postoperative days	Total dosage of acetominophen in milligrams. Acetominophen is a non-opioid analgesic medication.
Ibuprofen Dosage	3-4 postoperative days	Total ibuprofen dosage in milligrams. Ibuprofen is a non-steroidal anti-inflammatory (NSAID) medication used to reduce pain and inflammation.
Time to OOB	3-4 post-operative days	Time to get out of bed (OOB) measured in hours
Time to First BM	3-4 post-operative days	Time to first bowel movement (BM) measured in hours
Level of Sedation	3-4 post-operative days	Level of sedation (0-10 scale) was measured by provider observation via a Visual Analogue Scale. Higher scores mean more sedation.
Number of Participants Who Found the Device Acceptable	3-4 days postoperatively	Device acceptability questionnaire asked participants in the intervention group if TENS positively impacted their recovery. Responses indicated the number of participants who indicated "Yes" that TENS positively impacted their recovery. Responses of "Unsure" or "No" were coded as "No" responses.
McGill Pain Questionnaire	6 weeks postoperatively	The Short-Form McGill Pain Questionnaire (SFMPQ) includes 15 items that describe the type of pain from sensory and affective domains. Each item is scored 0 to 3, with scores\>1 indicating that pain aligns with that descriptor. Higher scores indicate more severe symptoms.
Neuropathic Pain Scale (NPS)	3-4 postoperative days	Neuropathic Pain Scale (NPS) is a 10-item self-questionnaire that measures the degree of neuropathic pain. Higher scores indicate more severe pain. Total score ranges from 0 to 100, with 100 indicating the most severe neuropathic pain. Total NPS score is reported.
Acceptability Questionnaire	6 weeks postoperatively	Device acceptability questionnaire included 5 total self-report questions. Device usage (time used) and discharge medications were text entry questions. Three yes/no questions asked about impacts on pain relief, recovery and breastfeeding.
Neuropathic Pain Scale	6 weeks postoperatively	Neuropathic Pain Scale (NPS) is a 10-item questionnaire that measures the degree of neuropathic pain. Higher scores indicate more severe pain.