Use of On-Q Pump for Pain Post C-Section

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Multimodal Post-Cesarean Analgesia With Spinal Morphine and Continuous Wound Infiltration of Ropivacaine Using the OnQ® Elastomeric Pump: A Dose-Ranging Study Using a High-Volume, Low-Dose Protocol

Conditions
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Pain

Intervention / Treatment
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* Drug: Normal saline
* Device: On-Q ® elastomeric pump
* Drug: Ropivacaine 0.1%
* Drug: Ropivacaine 0.2%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients at Emory University Hospital Midtown undergoing non-emergent, scheduled or unscheduled first, second or third Cesarean sections Patients who are American Society of Anesthesiology (ASA) Class I-III Patients are at least 34 weeks pregnant Patients to receive spinal anesthesia for their procedure Patients who are 18 years of age or older Patient willing and able to provide written informed consent Exclusion Criteria: Patients with 3 or more prior Cesarean sections Patients undergoing emergent cesarean section with or without general anesthesia Patients with known allergy to morphine, ketorolac, and/or amide local anesthetics Patients who will not receive spinal anesthesia Patients who are less than 34 weeks pregnant Patients with significant maternal cardiac, liver or renal disease Patients with maternal history of narcotic abuse or dependency Patient with pre-operative fever (>100.4 degrees F) Patients less than 18 years old

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ropivacaine 0.1%<br>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. | Drug: Ropivacaine 0.1%<br>* 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.<br>* Other names: Naropin;Device: On-Q ® elastomeric pump<br>* 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.<br>* Other names: On-Q PainBuster;|
| Experimental: Ropivacaine 0.2%<br>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. | Drug: Ropivacaine 0.2%<br>* 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.<br>* Other names: Naropin;Device: On-Q ® elastomeric pump<br>* 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.<br>* Other names: On-Q PainBuster;|
| Active Comparator: Normal Saline<br>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. | Drug: Normal saline<br>* 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.<br>Device: On-Q ® elastomeric pump<br>* 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.<br>* Other names: On-Q PainBuster;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesia, Cesarean section, Opiates