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The main purpose of this study is to examine if pain levels treated with intrathecal (IT) preservative-free morphine (PFM) after a cesarean section improve with the additional use of continuous subfascial wound infiltration with ropivacaine using the OnQ® elastomeric pump system.
The main purpose of this study is to examine if pain levels treated with intrathecal (IT) preservative-free morphine (PFM) after a cesarean section improve with the additional use of continuous subfascial wound infiltration with ropivacaine using the OnQ® elastomeric pump system. As a double-blinded, randomized, placebo controlled study, women undergoing first, second or third cesarean section will be randomly assigned to one of 3 different groups. Group 1 will receive saline, group 2 will be given ropivacaine 0.1%, group 3 will be given ropivacaine 0.2%, all at a rate of 8ml/hr via the OnQ® pump system. Each group will also receive an 8mL bolus of the previously assigned infusate. The investigator will assess pain at rest and with movement at different time periods during the recovery process through 3 months post operatively. The investigator will also assess if the use of this system decreases the need for other pain medications and reduces the potential side-effects of pain treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine 0.1% | Active Comparator | Subjects undergoing their first,second or third cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section. |
|
| Ropivacaine 0.2% | Experimental | Subjects undergoing their first,second or third cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section. |
|
| Normal Saline | Active Comparator | Subjects undergoing their first, second or third cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine 0.1% | Drug | Ropivacaine 0.1% is a local anaesthetic drug and will be administered as a single bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump. The bolus dose of 8ml of 0.1% ropivacaine will be administered via a multiport, silver-impregnated catheter (6-10cm) placed above the rectus muscle parallel to the fascial incision, using a preloaded syringe. The infusion will be delivered by the On-Q® elastomeric pump pre-set to deliver 8ml/hr of 0.1% ropivacaine for 72 hours post-operatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Scores During Cough From Baseline | The intensity of pain during cough will be measured using a visual analogue pain scale (VAPS). Subjects will be instructed to indicate the intensity of the pain by marking on a 100-mm vertical lines with terms describing the extremes of pain intensity. The lines are anchored with "no pain" at the bottom and "worst imaginable pain" at the top. Pain scores range from 0-100, so the change in pain score (post- minus pre-) can theoretically range from -100 to 100. A negative score indicates an improvement in pain. Higher scores indicate higher intensities of pain. | 2 hours post baseline, 6, 12, 24, 48, 72 hours post baseline |
| Change in Pain Scores During 20°Straight Leg Raise | The intensity of pain during 20° straight leg raise will be measured using a visual analogue pain scale (VAPS). Subjects will be instructed to indicate the intensity of the pain by marking on a 100-mm vertical lines with terms describing the extremes of pain intensity. The lines are anchored with "no pain" at the bottom and "worst imaginable pain" at the top. Higher scores indicate higher intensities of pain. | Baseline (At zero time, the time of the first dosing using the On-Q catheter), 2, 6, 12, 24, 48, 72 hours post baseline |
| Change in Intensity of Pain: Numerical Pain Scale (NPS) From Baseline | Post-operative pain will be measured using a numerical pain scale (NPS). Subjects will be asked to indicate the level of pain with 0 being no pain and 10 being the worst imaginable pain. Higher scores indicate higher intensities of pain. Participants will report intensity of pain at the week 6 and 3 month time points through a telephone call. | 6 weeks, 3 months |
| Change in Intensity of Pain: VAPS From Baseline | Incisional pain will be measured using a visual analogue pain scale (VAPS). Subjects will be instructed to indicate the intensity of the pain by marking on a 100-mm vertical lines with terms describing the extremes of pain intensity. The lines are anchored with "no pain" at the bottom and "worst imaginable pain" at the top. Pain scores range from 0-100, so the change in pain score (post- minus pre-) can theoretically range from -100 to 100. A negative score indicates an improvement in pain. Higher scores indicate higher intensities of pain. Participants will report intensity of pain 2hrs post intervention, 6hr, 12hr, 24hr, 48hr, and 72hr post-intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Time From Baseline to First Dose of Rescue Medications | The time to dosing with the first rescue medications like, non-steroidal anti-inflammatory drugs and morphine, for breakthrough pain will be noted. A shorter time to dosing indicates an increased intensity of pain. It will be recorded in hours post intervention. | Baseline (At zero time, the time of the first dosing using the On-Q catheter), 72 hours post-operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Dolak, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States |
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Participants were enrolled between July 2015 and July 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ropivacaine 0.1% | Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section. |
| FG001 | Ropivacaine 0.2% | Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section. |
| FG002 | Normal Saline | Subjects undergoing cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants that completed the trial were included the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ropivacaine 0.1% | Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section. |
| BG001 | Ropivacaine 0.2% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain Scores During Cough From Baseline | The intensity of pain during cough will be measured using a visual analogue pain scale (VAPS). Subjects will be instructed to indicate the intensity of the pain by marking on a 100-mm vertical lines with terms describing the extremes of pain intensity. The lines are anchored with "no pain" at the bottom and "worst imaginable pain" at the top. Pain scores range from 0-100, so the change in pain score (post- minus pre-) can theoretically range from -100 to 100. A negative score indicates an improvement in pain. Higher scores indicate higher intensities of pain. | The drop of participants at 72 hours reflects patients who were discharged early, prior to the 72 hr Visit. Other missing values occurred when patients could not be located at the scheduled time because they were not in their room. | Posted | Median | Inter-Quartile Range | score on a scale | 2 hours post baseline, 6, 12, 24, 48, 72 hours post baseline |
|
Adverse Evens were collected during follow up time (Up to 3 months post intervention).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ropivacaine 0.1% | Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section. |
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Research funded internally,no budget for data collection personnel. For LATCH scores, data not obtained by nurses during shift. Early discharge of many patients prior to the 72 hr time point. Significant patient drop out post hospital discharge.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine Egan | Emory University | 404-727-8463 | kfegan@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 6, 2019 | Jul 21, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Ropivacaine 0.2% | Drug | Ropivacaine 0.2% is a local anaesthetic drug and will be administered as a single bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump. The bolus dose of 8ml of 0.2% ropivacaine will be administered via a multiport, silver-impregnated catheter (6-10cm) placed above the rectus muscle parallel to the fascial incision, using a preloaded syringe. The infusion will be delivered by the On-Q® elastomeric pump pre-set to deliver 8ml/hr of 0.2% ropivacaine for 72 hours post-operatively. |
|
|
| Normal saline | Drug | Normal saline will be administered as a single bolus dose of 8ml of normal saline followed by an infusion of normal saline using the On-Q® elastomeric pump. The bolus dose of 8ml of normal saline will be administered via a multiport, silver-impregnated catheter (6-10cm) placed above the rectus muscle parallel to the fascial incision, using a preloaded syringe. The infusion will be delivered by the On-Q® elastomeric pump pre-set to deliver 8ml/hr normal saline for 72 hours post-operatively. |
|
| On-Q ® elastomeric pump | Device | The On-Q® elastomeric pump automatically and continuously delivers a regulated flow of 0.1% or 0.2% ropivacaine or normal saline locally to the surgical site for 72 hours post-operatively. The infusion will be delivered by pre-setting the On-Q® elastomeric pump to deliver at the rate of 8ml/hr for 72 hours post-operatively. |
|
|
| 24 hours post-intervention, 48 hrs, and 72hr post-intervention. |
| Change in McGill Pain Questionnaire Score From Baseline | Pain with movement will be assessed using the self-report mini-McGill pain questionnaire, consisting of the first 15 questions of the McGill questionnaire, scores 0-3 points for each. It can theoretically range from 0 to 45, with 45 correlating with worse pain. | 2 hours post-intervention, 6 hours, 12 hours, 24 hours, 72 hours, 6 weeks, 3 months post-intervention |
| Change in Pain Scores at Rest From Baseline | The intensity of pain at rest will be measured using a visual analogue pain scale (VAPS). Subjects will be instructed to indicate the intensity of the pain by marking on a 100-mm vertical lines with terms describing the extremes of pain intensity. The lines are anchored with "no pain" at the bottom and "worst imaginable pain" at the top. Higher scores indicate higher intensities of pain. | 2 hours post-intervention, 6 hours, 12 hours, 24 hours, 48 hous, 72 hours post baseline |
| Breastfeeding Success | Breastfeeding success will be measured using LATCH scores. The LATCH system assigns a numerical score, 0, 1, or 2, to five key components of breastfeeding: "L" is for how well the infant latches onto the breast, "A" is for the amount of audible swallowing noted, "T" is for the mother's nipple type, "C" is for the mother's level of comfort and "H" is for the amount of help the mother needs to hold her infant to the breast. The theoretical range of the Latch score is 0 to 10. Higher scores indicate higher success with breastfeeding. | In the post-anesthesia care unit (up to 2 hours post-operatively), 72 hours post-operatively |
| Number of Participants With Catheter or Infiltrate-related Issues at 24, 48 and 72 Hours Post-intervention | The cesarean section incision and the catheter insertion site will be evaluated. Any catheter or infiltrate-related issues like wound infection and seroma formation will be noted. It will be reported as number of issues. Wounds will be assessed for infection or dehiscence. Clean wound lines with no evidence of infection indicate better healing. | 24 hours, 48 hours, 72 hours post intervention |
| Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention | At the 6 week and 3-month follow-up phone calls the participant will be asked about the presence of wound dysesthesia (numbness, tingling, burning, pricking, allodynia, or hyperesthesia), occurrence of infection, dehiscence, and keloid formation. | 6 weeks postintervention, 3 months postintervention |
| Cost Analysis | A cost analysis will occur for the inpatient stay. Costs to be assessed include cost for preparation of the drugs and devices, monitoring/supervision costs based on nursing and physician interventions and cost of days spent in the hospital. | At the time of hospital discharge (average of 3 days) |
| Patient Satisfaction at 72 Hours Post Intervention | Patient satisfaction will be assessed by using the visual analog scale (VAS). The visual analog scale (VAS) for satisfaction is a horizontal line 100mm long. At the beginning and the end, there are two descriptors representing extremes of satisfaction. The subjects will be asked to rate their satisfaction by making a vertical mark on the 100mm line, where, 0= least satisfied and 100=most satisfied. Higher scores indicate higher levels of satisfaction. | 72 hours post-operatively |
| Dosing Amount of Non-steroidal Anti-inflammatory Drugs | The total dose of non-steroidal anti-inflammatory drugs (NSAIDs) in mg will be recorded for each of the first three post-operative days and after discharge as indicated, along with a cumulative total. Higher doses of NSAIDs usage indicate higher intensities of pain. | 24 post-operatively, 72 hours post-operatively |
| Amount of Opioid Use | The amount of opioid use will be quantified in terms of morphine equivalents given in mg both by post -operative day and with a cumulative total. Higher amounts of opioid use indicates higher degrees of pain. | 24 post-operatively, 72 hours post-operatively |
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section. |
| BG002 | Normal Saline | Subjects undergoing cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section. |
| OG001 | Ropivacaine 0.2% | Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section. |
| OG002 | Normal Saline | Subjects undergoing cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section. |
|
|
| Primary | Change in Pain Scores During 20°Straight Leg Raise | The intensity of pain during 20° straight leg raise will be measured using a visual analogue pain scale (VAPS). Subjects will be instructed to indicate the intensity of the pain by marking on a 100-mm vertical lines with terms describing the extremes of pain intensity. The lines are anchored with "no pain" at the bottom and "worst imaginable pain" at the top. Higher scores indicate higher intensities of pain. | The drop of participants at 72 hours reflects patients who were discharged early, prior to the 72 hr Visit. Other missing values occurred when patients could not be located at the scheduled time because they were not in their room. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline (At zero time, the time of the first dosing using the On-Q catheter), 2, 6, 12, 24, 48, 72 hours post baseline |
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| Primary | Change in Intensity of Pain: Numerical Pain Scale (NPS) From Baseline | Post-operative pain will be measured using a numerical pain scale (NPS). Subjects will be asked to indicate the level of pain with 0 being no pain and 10 being the worst imaginable pain. Higher scores indicate higher intensities of pain. Participants will report intensity of pain at the week 6 and 3 month time points through a telephone call. | The difference reflects the number of patients who were lost to follow up at 6 weeks and 3 months. | Posted | Median | Inter-Quartile Range | units on a scale | 6 weeks, 3 months |
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| Primary | Change in Intensity of Pain: VAPS From Baseline | Incisional pain will be measured using a visual analogue pain scale (VAPS). Subjects will be instructed to indicate the intensity of the pain by marking on a 100-mm vertical lines with terms describing the extremes of pain intensity. The lines are anchored with "no pain" at the bottom and "worst imaginable pain" at the top. Pain scores range from 0-100, so the change in pain score (post- minus pre-) can theoretically range from -100 to 100. A negative score indicates an improvement in pain. Higher scores indicate higher intensities of pain. Participants will report intensity of pain 2hrs post intervention, 6hr, 12hr, 24hr, 48hr, and 72hr post-intervention. | The differences in the number of participants reflect patients who were discharged earlier than 72 hours and patients whose assessments could not be completed because they were not available (out of the room, etc). All 0 values are real reports of "no pain", which was the median score for Outcome 3. None of them represent missing values or NA. | Posted | Median | Inter-Quartile Range | units on a scale | 24 hours post-intervention, 48 hrs, and 72hr post-intervention. |
|
|
|
| Primary | Change in McGill Pain Questionnaire Score From Baseline | Pain with movement will be assessed using the self-report mini-McGill pain questionnaire, consisting of the first 15 questions of the McGill questionnaire, scores 0-3 points for each. It can theoretically range from 0 to 45, with 45 correlating with worse pain. | The differences in number of participants reflect patients who were discharged earlier than 72 hours and patients whose assessments could not be completed because they were not available (out of the room, etc. ) | Posted | Median | Inter-Quartile Range | score on a scale | 2 hours post-intervention, 6 hours, 12 hours, 24 hours, 72 hours, 6 weeks, 3 months post-intervention |
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|
| Primary | Change in Pain Scores at Rest From Baseline | The intensity of pain at rest will be measured using a visual analogue pain scale (VAPS). Subjects will be instructed to indicate the intensity of the pain by marking on a 100-mm vertical lines with terms describing the extremes of pain intensity. The lines are anchored with "no pain" at the bottom and "worst imaginable pain" at the top. Higher scores indicate higher intensities of pain. | The differences in number of participants reflect patients who were discharged earlier than 72 hours and patients whose assessments could not be completed because they were not available (out of the room, etc. ) | Posted | Median | Inter-Quartile Range | score on a scale | 2 hours post-intervention, 6 hours, 12 hours, 24 hours, 48 hous, 72 hours post baseline |
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| Secondary | Change in Time From Baseline to First Dose of Rescue Medications | The time to dosing with the first rescue medications like, non-steroidal anti-inflammatory drugs and morphine, for breakthrough pain will be noted. A shorter time to dosing indicates an increased intensity of pain. It will be recorded in hours post intervention. | Posted | Median | Inter-Quartile Range | Hours | Baseline (At zero time, the time of the first dosing using the On-Q catheter), 72 hours post-operatively |
|
|
|
| Secondary | Breastfeeding Success | Breastfeeding success will be measured using LATCH scores. The LATCH system assigns a numerical score, 0, 1, or 2, to five key components of breastfeeding: "L" is for how well the infant latches onto the breast, "A" is for the amount of audible swallowing noted, "T" is for the mother's nipple type, "C" is for the mother's level of comfort and "H" is for the amount of help the mother needs to hold her infant to the breast. The theoretical range of the Latch score is 0 to 10. Higher scores indicate higher success with breastfeeding. | Data was not obtained/recorded by nurses during shift and some patients were not available (out of the room, etc). | Posted | Median | Inter-Quartile Range | score on a scale | In the post-anesthesia care unit (up to 2 hours post-operatively), 72 hours post-operatively |
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| Secondary | Number of Participants With Catheter or Infiltrate-related Issues at 24, 48 and 72 Hours Post-intervention | The cesarean section incision and the catheter insertion site will be evaluated. Any catheter or infiltrate-related issues like wound infection and seroma formation will be noted. It will be reported as number of issues. Wounds will be assessed for infection or dehiscence. Clean wound lines with no evidence of infection indicate better healing. | Posted | Count of Participants | Participants | 24 hours, 48 hours, 72 hours post intervention |
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| Secondary | Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention | At the 6 week and 3-month follow-up phone calls the participant will be asked about the presence of wound dysesthesia (numbness, tingling, burning, pricking, allodynia, or hyperesthesia), occurrence of infection, dehiscence, and keloid formation. | Posted | Count of Participants | Participants | 6 weeks postintervention, 3 months postintervention |
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| Secondary | Cost Analysis | A cost analysis will occur for the inpatient stay. Costs to be assessed include cost for preparation of the drugs and devices, monitoring/supervision costs based on nursing and physician interventions and cost of days spent in the hospital. | Posted | Mean | Standard Deviation | Dollars | At the time of hospital discharge (average of 3 days) |
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| Secondary | Patient Satisfaction at 72 Hours Post Intervention | Patient satisfaction will be assessed by using the visual analog scale (VAS). The visual analog scale (VAS) for satisfaction is a horizontal line 100mm long. At the beginning and the end, there are two descriptors representing extremes of satisfaction. The subjects will be asked to rate their satisfaction by making a vertical mark on the 100mm line, where, 0= least satisfied and 100=most satisfied. Higher scores indicate higher levels of satisfaction. | Posted | Mean | Standard Deviation | units on a scale | 72 hours post-operatively |
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| Secondary | Dosing Amount of Non-steroidal Anti-inflammatory Drugs | The total dose of non-steroidal anti-inflammatory drugs (NSAIDs) in mg will be recorded for each of the first three post-operative days and after discharge as indicated, along with a cumulative total. Higher doses of NSAIDs usage indicate higher intensities of pain. | Posted | Mean | Standard Deviation | mg | 24 post-operatively, 72 hours post-operatively |
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| Secondary | Amount of Opioid Use | The amount of opioid use will be quantified in terms of morphine equivalents given in mg both by post -operative day and with a cumulative total. Higher amounts of opioid use indicates higher degrees of pain. | Posted | Mean | Standard Deviation | mg | 24 post-operatively, 72 hours post-operatively |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Ropivacaine 0.2% | Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG002 | Normal Saline | Subjects undergoing cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| Change in score at 6-hours post baseline |
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| Change in score at 12-hours post baseline |
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| Change in score at 24-hours post baseline |
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| Change in score at 48-hours post baseline |
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| Change in score at 72-hours post baseline |
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| Change at 3 months post intervention |
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| Change in score at 72 hours post intervention |
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| 6 hrs post Baseline |
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| 12 hrs post Baseline |
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| 24 hrs post Baseline |
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| 48 hrs post Baseline |
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| 72 hrs post Baseline |
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| 6 weeks post Baseline |
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| 3 months post Baseline |
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| Change in score at 6-hours post baseline |
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| Change in score at 12-hours post baseline |
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| Change in score at 24-hours post baseline |
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| Change in score at 48-hours post baseline |
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| Change in score at 72-hours post baseline |
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| 72 hours post intervention |
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| 72 hours post intervention |
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| 6 Weeks- Dehiscence |
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| 6 Weeks- Keloid Formation |
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| 3 Months- Wound Dysesthesia |
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| 3 Months - Infection |
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| 3 Months- Dehiscence |
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| 3 Months- Keloid Formation |
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