TENS and Opioid Use After Cesarean Delivery
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 2/20/2019 |
| Start Date: | November 9, 2018 |
| End Date: | June 2020 |
| Contact: | Adrienne Simonds, PT PhD |
| Email: | simondad@shp.rutgers.edu |
| Phone: | 609-477-8538 |
Transcutaneous Electrical Nerve Stimulation and Maternal Opioid Use After Cesarean Delivery
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.
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.
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.
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.
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
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