Cesarean Section Complications, Opioid Use
Conditions
Keywords
Post-cesarean pain, Transcutaneous Electrical Nerve Stimulation
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.
Interventions
DEVICETranscutaneous 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.
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Not able to be masked
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 | 3-4 days 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. The score range is 0 to 78, with 78 representing more severe pain. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| 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. | 3 |
| Post-CS Routine Care Routine pharmacologic care will be provided. | 5 |
| Opioid Addicted Post-CS Routine Care Routine pharmacologic care will be provided. | 2 |
| Total | 15 |
Baseline characteristics
| Characteristic | Post-CS TENS | Opioid Addicted Post-CS TENS | Post-CS Routine Care | Opioid Addicted Post-CS Routine Care | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 3 Participants | 5 Participants | 2 Participants | 15 Participants |
| Cesarean section delivery | 5 Participants | 3 Participants | 5 Participants | 2 Participants | 15 Participants |
| History of prior opioid addiction | 0 Participants | 3 Participants | 0 Participants | 2 Participants | 5 Participants |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Region of Enrollment United States | 5 participants | 3 participants | 5 participants | 2 participants | 15 participants |
| Sex: Female, Male Female | 5 Participants | 3 Participants | 5 Participants | 2 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 3 | 0 / 5 | 0 / 2 |
| other Total, other adverse events | 0 / 5 | 0 / 3 | 0 / 5 | 0 / 2 |
| serious Total, serious adverse events | 0 / 5 | 0 / 3 | 0 / 5 | 0 / 2 |
Outcome results
Primary
Post-operative Pain Ratings
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.
Time frame: 3-4 post-operative days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Post-CS TENS | Post-operative Pain Ratings | 2.90 units on a scale | Standard Deviation 1.9 |
| Opioid Addicted Post-CS TENS | Post-operative Pain Ratings | 3.7 units on a scale | Standard Deviation 2.97 |
| Post-CS Routine Care | Post-operative Pain Ratings | 2.58 units on a scale | Standard Deviation 2.29 |
| Opioid Addicted Post-CS Routine Care | Post-operative Pain Ratings | 4.24 units on a scale | Standard Deviation 2.9 |
Secondary
Acceptability Questionnaire
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.
Time frame: 6 weeks postoperatively
Population: Data was not collected because participants could not be reached.
Secondary
Acetominophen Dosage
Total dosage of acetominophen in milligrams. Acetominophen is a non-opioid analgesic medication.
Time frame: 3-4 postoperative days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Post-CS TENS | Acetominophen Dosage | 3335 Milligrams | Standard Deviation 578.68 |
| Opioid Addicted Post-CS TENS | Acetominophen Dosage | 3750 Milligrams | Standard Deviation 3031.08 |
| Post-CS Routine Care | Acetominophen Dosage | 1955 Milligrams | Standard Deviation 1502.96 |
| Opioid Addicted Post-CS Routine Care | Acetominophen Dosage | 5050 Milligrams | Standard Deviation 4384.06 |
Secondary
Ibuprofen Dosage
Total ibuprofen dosage in milligrams. Ibuprofen is a non-steroidal anti-inflammatory (NSAID) medication used to reduce pain and inflammation.
Time frame: 3-4 postoperative days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Post-CS TENS | Ibuprofen Dosage | 4680 Milligrams | Standard Deviation 1154.12 |
| Opioid Addicted Post-CS TENS | Ibuprofen Dosage | 1400 Milligrams | Standard Deviation 916.52 |
| Post-CS Routine Care | Ibuprofen Dosage | 4500 Milligrams | Standard Deviation 774.6 |
| Opioid Addicted Post-CS Routine Care | Ibuprofen Dosage | 4500 Milligrams | Standard Deviation 1272.79 |
Secondary
Level of Sedation
Level of sedation (0-10 scale) was measured by provider observation via a Visual Analogue Scale. Higher scores mean more sedation.
Time frame: 3-4 post-operative days
Population: This data were not collected due to unanticipated error.
Secondary
McGill Pain Questionnaire
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.
Time frame: 6 weeks postoperatively
Population: Data was not collected because participants could not be reached.
Secondary
McGill Pain Questionnaire
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. The score range is 0 to 78, with 78 representing more severe pain.
Time frame: 3-4 days postoperatively
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Post-CS TENS | McGill Pain Questionnaire | 7.8 score on a scale |
| Opioid Addicted Post-CS TENS | McGill Pain Questionnaire | 19 score on a scale |
| Post-CS Routine Care | McGill Pain Questionnaire | 10 score on a scale |
| Opioid Addicted Post-CS Routine Care | McGill Pain Questionnaire | 19 score on a scale |
Secondary
Milligrams Morphine Equivalent
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.
Time frame: 3-4 post-operative days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Post-CS TENS | Milligrams Morphine Equivalent | 58.5 Milligrams | Standard Deviation 18.67 |
| Opioid Addicted Post-CS TENS | Milligrams Morphine Equivalent | 182.83 Milligrams | Standard Deviation 112.79 |
| Post-CS Routine Care | Milligrams Morphine Equivalent | 57 Milligrams | Standard Deviation 35.42 |
| Opioid Addicted Post-CS Routine Care | Milligrams Morphine Equivalent | 105 Milligrams | Standard Deviation 84.85 |
Secondary
Neuropathic Pain Scale
Neuropathic Pain Scale (NPS) is a 10-item questionnaire that measures the degree of neuropathic pain. Higher scores indicate more severe pain.
Time frame: 6 weeks postoperatively
Population: Data was not collected because participants could not be reached.
Secondary
Neuropathic Pain Scale (NPS)
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.
Time frame: 3-4 postoperative days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Post-CS TENS | Neuropathic Pain Scale (NPS) | 22.4 score on a scale |
| Opioid Addicted Post-CS TENS | Neuropathic Pain Scale (NPS) | 49 score on a scale |
| Post-CS Routine Care | Neuropathic Pain Scale (NPS) | 24.875 score on a scale |
| Opioid Addicted Post-CS Routine Care | Neuropathic Pain Scale (NPS) | 64.5 score on a scale |
Secondary
Number of Participants Who Found the Device Acceptable
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.
Time frame: 3-4 days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Post-CS TENS | Number of Participants Who Found the Device Acceptable | 3 Participants |
| Opioid Addicted Post-CS TENS | Number of Participants Who Found the Device Acceptable | 1 Participants |
| Post-CS Routine Care | Number of Participants Who Found the Device Acceptable | 0 Participants |
| Opioid Addicted Post-CS Routine Care | Number of Participants Who Found the Device Acceptable | 0 Participants |
Secondary
Time to First BM
Time to first bowel movement (BM) measured in hours
Time frame: 3-4 post-operative days
Population: This data were not collected due to unanticipated error.
Secondary
Time to OOB
Time to get out of bed (OOB) measured in hours
Time frame: 3-4 post-operative days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Post-CS TENS | Time to OOB | 11.2 hours | Standard Deviation 6.3 |
| Opioid Addicted Post-CS TENS | Time to OOB | 16.7 hours | Standard Deviation 2.1 |
| Post-CS Routine Care | Time to OOB | 14.4 hours | Standard Deviation 6.5 |
| Opioid Addicted Post-CS Routine Care | Time to OOB | 20.0 hours | Standard Deviation 1.4 |