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

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ClinicalTrials.gov Identifier: NCT02579629
Recruitment Status : Enrolling by invitation
First Posted : October 19, 2015
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
James Dolak, Emory University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Drug: Ropivacaine 0.1% Drug: Ropivacaine 0.2% Drug: Normal saline Device: On-Q ® elastomeric pump Phase 4

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: 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
Study Start Date : July 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: Ropivacaine 0.1%
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%
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.
Other Name: Naropin

Device: On-Q ® elastomeric pump
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.
Other Name: On-Q PainBuster

Experimental: Ropivacaine 0.2%
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%
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.
Other Name: Naropin

Device: On-Q ® elastomeric pump
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.
Other Name: On-Q PainBuster

Active Comparator: Normal Saline
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
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.

Device: On-Q ® elastomeric pump
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.
Other Name: On-Q PainBuster




Primary Outcome Measures :
  1. Change in pain scores during cough [ Time Frame: Baseline (At zero time, the time of the first dosing using the On-Q catheter), 2 hours 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. Higher scores indicate higher intensities of pain.

  2. Change in pain scores during cough [ Time Frame: 6 hours from baseline,12 hours 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. Higher scores indicate higher intensities of pain.

  3. Change in pain scores during cough [ Time Frame: 24 hours from baseline, 48 hours from baseline, 72 hours 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. Higher scores indicate higher intensities of pain.

  4. Change in pain scores during 20°straight leg raise [ Time Frame: Baseline (At zero time, the time of the first dosing using the On-Q catheter), 2 hours from baseline ]
    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.

  5. Change in pain scores during 20°straight leg raise [ Time Frame: 6 hours from baseline,12 hours from baseline ]
    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.

  6. Change in pain scores during 20°straight leg raise [ Time Frame: 24 hours from baseline, 48 hours from baseline, 72 hours from baseline ]
    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.

  7. Change in intensity of pain [ Time Frame: 24 hours, 48 hours, 72 hours, 6 weeks, 3 months ]
    Post-operative pain will be quantitated 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.


Secondary Outcome Measures :
  1. Change in McGill pain questionnaire score [ Time Frame: Baseline (At zero time, the time of the first dosing using the On-Q catheter), 2 hours, 6 hours, 12 hours, 24 hours, 72 hours, 6 weeks, 3 months ]
    Pain with movement will be assessed using the self-report McGill pain questionnaire.This is composed of 78 words, of which subjects will choose those that best describe their experience of pain. Seven words are selected from the following categories: dimension 1 to 10 (pain descriptors); dimensions 11 to 15 (affective components of pain), dimension 16 (evaluation of pain), and dimension 17 to 20 (miscellaneous). Scores are calculated by summing values associated with each word. Scores range from 0 (no pain) to 78 (severe pain). Participants will respond to the McGill pain questionnaire at the week 6 and 3 month time points through a telephone call.

  2. Time to first dose of rescue medications [ Time Frame: Baseline (At zero time, the time of the first dosing using the On-Q catheter), 72 hours post-operatively ]
    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.

  3. Breastfeeding success [ Time Frame: In the post-anesthesia care unit (up to 2 hours post-operatively), 72 hours post-operatively ]
    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. Higher scores indicate higher success with breastfeeding.

  4. Change in post-operative wound evaluation [ Time Frame: 24 hours, 48 hours, 72 hours ]
    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. Wounds will be assessed for infection or dehiscence. Clean wound lines with no evidence of infection indicate better healing.

  5. Change in post-operative wound healing [ Time Frame: 6 weeks, 3 months ]
    At the 4-6 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. Pain scores at rest [ Time Frame: Baseline (At zero time, the time of the first dosing using the On-Q catheter), 2 hours, 6 hours, 12 hours, 24 hours, 72 hours ]
    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.

  7. Cost analysis [ Time Frame: At the time of hospital discharge (average of 3 days) ]
    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.

  8. Patient satisfaction [ Time Frame: 72 hours post-operatively ]
    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.

  9. Dosing amount of non-steroidal anti-inflammatory drugs [ Time Frame: 24 post-operatively, 72 hours post-operatively ]
    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.

  10. Severity of opioid side effects [ Time Frame: Baseline (At zero time, the time of the first dosing using the On-Q catheter), 72 hours post-operatively ]
    The severity of opioid central and/or systemic side effects like pruritus, nausea, vomiting, somnolence, and respiratory depression will be assessed.

  11. Amount of opioid use [ Time Frame: 24 post-operatively, 72 hours post-operatively ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Female patients at Emory University Hospital Midtown undergoing non-emergent, scheduled or unscheduled first, second or third Cesarean sections
  2. Patients who are American Society of Anesthesiology (ASA) Class I-III
  3. Patients are at least 34 weeks pregnant
  4. Patients to receive spinal anesthesia for their procedure
  5. Patients who are 18 years of age or older
  6. Patient willing and able to provide written informed consent

Exclusion Criteria:

  1. Patients with 3 or more prior Cesarean sections
  2. Patients undergoing emergent cesarean section with or without general anesthesia
  3. Patients with known allergy to morphine, ketorolac, and/or amide local anesthetics
  4. Patients who will not receive spinal anesthesia
  5. Patients who are less than 34 weeks pregnant
  6. Patients with significant maternal cardiac, liver or renal disease
  7. Patients with maternal history of narcotic abuse or dependency
  8. Patient with pre-operative fever (>100.4 degrees F)
  9. Patients less than 18 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579629


Locations
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United States, Georgia
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: James Dolak, MD Emory University

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Responsible Party: James Dolak, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT02579629     History of Changes
Other Study ID Numbers: IRB00073292
First Posted: October 19, 2015    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by James Dolak, Emory University:
Analgesia
Cesarean section
Opiates

Additional relevant MeSH terms:
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Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents