Trial Outcomes & Findings for TENS and Opioid Use After Cesarean Delivery (NCT NCT03843788)
NCT ID: NCT03843788
Last Updated: 2024-10-29
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
3-4 post-operative days
Results posted on
2024-10-29
Participant Flow
Participant milestones
| Measure |
Post-CS 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.
Transcutaneous Electrical Nerve Stimulation (TENS): Starting 8 hours after cesarean section, the TENS unit will be applied with charges above and below the incision. The device will be set to high frequency (\>75 Hz) for pain relief. Intensity of stimulation will be set to patient threshold using the forearm as a guide. Stimulation will be turned on titrated to the level which is felt but not painful for the patient. It 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.
|
Opioid Addicted Post-CS 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.
Transcutaneous Electrical Nerve Stimulation (TENS): Starting 8 hours after cesarean section, the TENS unit will be applied with charges above and below the incision. The device will be set to high frequency (\>75 Hz) for pain relief. Intensity of stimulation will be set to patient threshold using the forearm as a guide. Stimulation will be turned on titrated to the level which is felt but not painful for the patient. It 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.
|
Post-CS Routine Care
Routine pharmacologic care will be provided.
|
Opioid Addicted Post-CS Routine Care
Routine pharmacologic care will be provided.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
5
|
2
|
|
Overall Study
COMPLETED
|
5
|
3
|
5
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Post-CS TENS
n=5 Participants
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.
Transcutaneous Electrical Nerve Stimulation (TENS): Starting 8 hours after cesarean section, the TENS unit will be applied with charges above and below the incision. The device will be set to high frequency (\>75 Hz) for pain relief. Intensity of stimulation will be set to patient threshold using the forearm as a guide. Stimulation will be turned on titrated to the level which is felt but not painful for the patient. It 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.
|
Opioid Addicted Post-CS TENS
n=3 Participants
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.
Transcutaneous Electrical Nerve Stimulation (TENS): Starting 8 hours after cesarean section, the TENS unit will be applied with charges above and below the incision. The device will be set to high frequency (\>75 Hz) for pain relief. Intensity of stimulation will be set to patient threshold using the forearm as a guide. Stimulation will be turned on titrated to the level which is felt but not painful for the patient. It 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.
|
Post-CS Routine Care
n=5 Participants
Routine pharmacologic care will be provided.
|
Opioid Addicted Post-CS Routine Care
n=2 Participants
Routine pharmacologic care will be provided.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=15 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=2 Participants
|
15 Participants
n=15 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=15 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=2 Participants
|
15 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=15 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
3 participants
n=3 Participants
|
5 participants
n=5 Participants
|
2 participants
n=2 Participants
|
15 participants
n=15 Participants
|
|
History of prior opioid addiction
|
0 Participants
n=5 Participants
|
3 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=2 Participants
|
5 Participants
n=15 Participants
|
|
Cesarean section delivery
|
5 Participants
n=5 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=2 Participants
|
15 Participants
n=15 Participants
|
PRIMARY outcome
Timeframe: 3-4 post-operative daysPost-operative pain rating (0-10 scale) using Visual Analog Scale (VAS). VAS scores correspond self-report pain intensity. Higher scores mean higher pain intensity.
Outcome measures
| Measure |
Post-CS TENS
n=5 Participants
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.
Transcutaneous Electrical Nerve Stimulation (TENS): Starting 8 hours after cesarean section, the TENS unit will be applied with charges above and below the incision. The device will be set to high frequency (\>75 Hz) for pain relief. Intensity of stimulation will be set to patient threshold using the forearm as a guide. Stimulation will be turned on titrated to the level which is felt but not painful for the patient. It 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.
|
Opioid Addicted Post-CS TENS
n=3 Participants
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.
Transcutaneous Electrical Nerve Stimulation (TENS): Starting 8 hours after cesarean section, the TENS unit will be applied with charges above and below the incision. The device will be set to high frequency (\>75 Hz) for pain relief. Intensity of stimulation will be set to patient threshold using the forearm as a guide. Stimulation will be turned on titrated to the level which is felt but not painful for the patient. It 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.
|
Post-CS Routine Care
n=5 Participants
Routine pharmacologic care will be provided.
|
Opioid Addicted Post-CS Routine Care
n=2 Participants
Routine pharmacologic care will be provided.
|
|---|---|---|---|---|
|
Post-operative Pain Ratings
|
2.90 units on a scale
Standard Deviation 1.9
|
3.7 units on a scale
Standard Deviation 2.97
|
2.58 units on a scale
Standard Deviation 2.29
|
4.24 units on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: 3-4 post-operative daysMilligrams 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.
Outcome measures
| Measure |
Post-CS TENS
n=5 Participants
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.
Transcutaneous Electrical Nerve Stimulation (TENS): Starting 8 hours after cesarean section, the TENS unit will be applied with charges above and below the incision. The device will be set to high frequency (\>75 Hz) for pain relief. Intensity of stimulation will be set to patient threshold using the forearm as a guide. Stimulation will be turned on titrated to the level which is felt but not painful for the patient. It 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.
|
Opioid Addicted Post-CS TENS
n=3 Participants
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.
Transcutaneous Electrical Nerve Stimulation (TENS): Starting 8 hours after cesarean section, the TENS unit will be applied with charges above and below the incision. The device will be set to high frequency (\>75 Hz) for pain relief. Intensity of stimulation will be set to patient threshold using the forearm as a guide. Stimulation will be turned on titrated to the level which is felt but not painful for the patient. It 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.
|
Post-CS Routine Care
n=5 Participants
Routine pharmacologic care will be provided.
|
Opioid Addicted Post-CS Routine Care
n=2 Participants
Routine pharmacologic care will be provided.
|
|---|---|---|---|---|
|
Milligrams Morphine Equivalent
|
58.5 Milligrams
Standard Deviation 18.67
|
182.83 Milligrams
Standard Deviation 112.79
|
57 Milligrams
Standard Deviation 35.42
|
105 Milligrams
Standard Deviation 84.85
|
SECONDARY outcome
Timeframe: 3-4 postoperative daysTotal dosage of acetominophen in milligrams. Acetominophen is a non-opioid analgesic medication.
Outcome measures
| Measure |
Post-CS TENS
n=5 Participants
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.
Transcutaneous Electrical Nerve Stimulation (TENS): Starting 8 hours after cesarean section, the TENS unit will be applied with charges above and below the incision. The device will be set to high frequency (\>75 Hz) for pain relief. Intensity of stimulation will be set to patient threshold using the forearm as a guide. Stimulation will be turned on titrated to the level which is felt but not painful for the patient. It 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.
|
Opioid Addicted Post-CS TENS
n=3 Participants
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.
Transcutaneous Electrical Nerve Stimulation (TENS): Starting 8 hours after cesarean section, the TENS unit will be applied with charges above and below the incision. The device will be set to high frequency (\>75 Hz) for pain relief. Intensity of stimulation will be set to patient threshold using the forearm as a guide. Stimulation will be turned on titrated to the level which is felt but not painful for the patient. It 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.
|
Post-CS Routine Care
n=5 Participants
Routine pharmacologic care will be provided.
|
Opioid Addicted Post-CS Routine Care
n=2 Participants
Routine pharmacologic care will be provided.
|
|---|---|---|---|---|
|
Acetominophen Dosage
|
3335 Milligrams
Standard Deviation 578.68
|
3750 Milligrams
Standard Deviation 3031.08
|
1955 Milligrams
Standard Deviation 1502.96
|
5050 Milligrams
Standard Deviation 4384.06
|
SECONDARY outcome
Timeframe: 3-4 postoperative daysTotal ibuprofen dosage in milligrams. Ibuprofen is a non-steroidal anti-inflammatory (NSAID) medication used to reduce pain and inflammation.
Outcome measures
| Measure |
Post-CS TENS
n=5 Participants
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.
Transcutaneous Electrical Nerve Stimulation (TENS): Starting 8 hours after cesarean section, the TENS unit will be applied with charges above and below the incision. The device will be set to high frequency (\>75 Hz) for pain relief. Intensity of stimulation will be set to patient threshold using the forearm as a guide. Stimulation will be turned on titrated to the level which is felt but not painful for the patient. It 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.
|
Opioid Addicted Post-CS TENS
n=3 Participants
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.
Transcutaneous Electrical Nerve Stimulation (TENS): Starting 8 hours after cesarean section, the TENS unit will be applied with charges above and below the incision. The device will be set to high frequency (\>75 Hz) for pain relief. Intensity of stimulation will be set to patient threshold using the forearm as a guide. Stimulation will be turned on titrated to the level which is felt but not painful for the patient. It 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.
|
Post-CS Routine Care
n=5 Participants
Routine pharmacologic care will be provided.
|
Opioid Addicted Post-CS Routine Care
n=2 Participants
Routine pharmacologic care will be provided.
|
|---|---|---|---|---|
|
Ibuprofen Dosage
|
4680 Milligrams
Standard Deviation 1154.12
|
1400 Milligrams
Standard Deviation 916.52
|
4500 Milligrams
Standard Deviation 774.6
|
4500 Milligrams
Standard Deviation 1272.79
|
SECONDARY outcome
Timeframe: 3-4 post-operative daysTime to get out of bed (OOB) measured in hours
Outcome measures
| Measure |
Post-CS TENS
n=5 Participants
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.
Transcutaneous Electrical Nerve Stimulation (TENS): Starting 8 hours after cesarean section, the TENS unit will be applied with charges above and below the incision. The device will be set to high frequency (\>75 Hz) for pain relief. Intensity of stimulation will be set to patient threshold using the forearm as a guide. Stimulation will be turned on titrated to the level which is felt but not painful for the patient. It 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.
|
Opioid Addicted Post-CS TENS
n=3 Participants
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.
Transcutaneous Electrical Nerve Stimulation (TENS): Starting 8 hours after cesarean section, the TENS unit will be applied with charges above and below the incision. The device will be set to high frequency (\>75 Hz) for pain relief. Intensity of stimulation will be set to patient threshold using the forearm as a guide. Stimulation will be turned on titrated to the level which is felt but not painful for the patient. It 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.
|
Post-CS Routine Care
n=5 Participants
Routine pharmacologic care will be provided.
|
Opioid Addicted Post-CS Routine Care
n=2 Participants
Routine pharmacologic care will be provided.
|
|---|---|---|---|---|
|
Time to OOB
|
11.2 hours
Standard Deviation 6.3
|
16.7 hours
Standard Deviation 2.1
|
14.4 hours
Standard Deviation 6.5
|
20.0 hours
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 3-4 post-operative daysPopulation: This data were not collected due to unanticipated error.
Time to first bowel movement (BM) measured in hours
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3-4 post-operative daysPopulation: This data were not collected due to unanticipated error.
Level of sedation (0-10 scale) was measured by provider observation via a Visual Analogue Scale. Higher scores mean more sedation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3-4 days postoperativelyDevice 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.
Outcome measures
| Measure |
Post-CS TENS
n=5 Participants
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.
Transcutaneous Electrical Nerve Stimulation (TENS): Starting 8 hours after cesarean section, the TENS unit will be applied with charges above and below the incision. The device will be set to high frequency (\>75 Hz) for pain relief. Intensity of stimulation will be set to patient threshold using the forearm as a guide. Stimulation will be turned on titrated to the level which is felt but not painful for the patient. It 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.
|
Opioid Addicted Post-CS TENS
n=2 Participants
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.
Transcutaneous Electrical Nerve Stimulation (TENS): Starting 8 hours after cesarean section, the TENS unit will be applied with charges above and below the incision. The device will be set to high frequency (\>75 Hz) for pain relief. Intensity of stimulation will be set to patient threshold using the forearm as a guide. Stimulation will be turned on titrated to the level which is felt but not painful for the patient. It 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.
|
Post-CS Routine Care
n=5 Participants
Routine pharmacologic care will be provided.
|
Opioid Addicted Post-CS Routine Care
n=2 Participants
Routine pharmacologic care will be provided.
|
|---|---|---|---|---|
|
Number of Participants Who Found the Device Acceptable
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3-4 days postoperativelyThe 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. The score range is 0 to 78, with 78 representing more severe pain.
Outcome measures
| Measure |
Post-CS TENS
n=5 Participants
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.
Transcutaneous Electrical Nerve Stimulation (TENS): Starting 8 hours after cesarean section, the TENS unit will be applied with charges above and below the incision. The device will be set to high frequency (\>75 Hz) for pain relief. Intensity of stimulation will be set to patient threshold using the forearm as a guide. Stimulation will be turned on titrated to the level which is felt but not painful for the patient. It 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.
|
Opioid Addicted Post-CS TENS
n=2 Participants
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.
Transcutaneous Electrical Nerve Stimulation (TENS): Starting 8 hours after cesarean section, the TENS unit will be applied with charges above and below the incision. The device will be set to high frequency (\>75 Hz) for pain relief. Intensity of stimulation will be set to patient threshold using the forearm as a guide. Stimulation will be turned on titrated to the level which is felt but not painful for the patient. It 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.
|
Post-CS Routine Care
n=4 Participants
Routine pharmacologic care will be provided.
|
Opioid Addicted Post-CS Routine Care
n=2 Participants
Routine pharmacologic care will be provided.
|
|---|---|---|---|---|
|
McGill Pain Questionnaire
|
7.8 score on a scale
Interval 3.0 to 13.0
|
19 score on a scale
Interval 11.0 to 27.0
|
10 score on a scale
Interval 4.0 to 14.0
|
19 score on a scale
Interval 18.0 to 20.0
|
SECONDARY outcome
Timeframe: 3-4 postoperative daysNeuropathic 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.
Outcome measures
| Measure |
Post-CS TENS
n=4 Participants
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.
Transcutaneous Electrical Nerve Stimulation (TENS): Starting 8 hours after cesarean section, the TENS unit will be applied with charges above and below the incision. The device will be set to high frequency (\>75 Hz) for pain relief. Intensity of stimulation will be set to patient threshold using the forearm as a guide. Stimulation will be turned on titrated to the level which is felt but not painful for the patient. It 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.
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Opioid Addicted Post-CS TENS
n=3 Participants
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.
Transcutaneous Electrical Nerve Stimulation (TENS): Starting 8 hours after cesarean section, the TENS unit will be applied with charges above and below the incision. The device will be set to high frequency (\>75 Hz) for pain relief. Intensity of stimulation will be set to patient threshold using the forearm as a guide. Stimulation will be turned on titrated to the level which is felt but not painful for the patient. It 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.
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Post-CS Routine Care
n=4 Participants
Routine pharmacologic care will be provided.
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Opioid Addicted Post-CS Routine Care
n=2 Participants
Routine pharmacologic care will be provided.
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Neuropathic Pain Scale (NPS)
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22.4 score on a scale
Interval 9.0 to 35.0
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49 score on a scale
Interval 49.0 to 49.0
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24.875 score on a scale
Interval 8.0 to 32.5
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64.5 score on a scale
Interval 58.0 to 71.0
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SECONDARY outcome
Timeframe: 6 weeks postoperativelyPopulation: Data was not collected because participants could not be reached.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeks postoperativelyPopulation: Data was not collected because participants could not be reached.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeks postoperativelyPopulation: Data was not collected because participants could not be reached.
Neuropathic Pain Scale (NPS) is a 10-item questionnaire that measures the degree of neuropathic pain. Higher scores indicate more severe pain.
Outcome measures
Outcome data not reported
Adverse Events
Post-CS TENS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Opioid Addicted Post-CS TENS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Post-CS Routine Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Opioid Addicted Post-CS Routine Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Adrienne Simonds
Rutgers, The State University of New Jersey
Phone: 8565667190
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place