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

September 24, 2020 updated by: James Dolak, Emory University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital Midtown

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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.
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 Names:
  • On-Q PainBuster
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 Names:
  • Naropin
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.
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 Names:
  • On-Q PainBuster
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Pain Scores During Cough From Baseline
Time Frame: 2 hours post baseline, 6, 12, 24, 48, 72 hours post 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
Time Frame: Baseline (At zero time, the time of the first dosing using the On-Q catheter), 2, 6, 12, 24, 48, 72 hours post 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.
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
Time Frame: 6 weeks, 3 months
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
Time Frame: 24 hours post-intervention, 48 hrs, and 72hr post-intervention.
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
Time Frame: 2 hours post-intervention, 6 hours, 12 hours, 24 hours, 72 hours, 6 weeks, 3 months post-intervention
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
Time Frame: 2 hours post-intervention, 6 hours, 12 hours, 24 hours, 48 hous, 72 hours post 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Time From Baseline 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. 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
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. 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
Time Frame: 24 hours, 48 hours, 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
Time Frame: 6 weeks postintervention, 3 months postintervention
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
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.
At the time of hospital discharge (average of 3 days)
Patient Satisfaction at 72 Hours Post Intervention
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.
72 hours post-operatively
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.
24 post-operatively, 72 hours post-operatively
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.
24 post-operatively, 72 hours post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: James Dolak, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 25, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 25, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00073292

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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