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

NCT02579629 | Completed Phase 4 Results

• 1 other identifier: IRB00073292
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Analgesia; Cesarean section; Opiates

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (8)

• Change in Time From Baseline to First Dose of Rescue Medications

  Baseline (At zero time, the time of the first dosing using the On-Q catheter), 72 hours post-operatively

• Breastfeeding Success

  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

  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

  6 weeks postintervention, 3 months postintervention

• Cost Analysis

  At the time of hospital discharge (average of 3 days)

Study Arms (3)

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.

Drug: Ropivacaine 0.1%; Device: On-Q ® elastomeric pump

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.

Drug: Ropivacaine 0.2%; Device: On-Q ® elastomeric pump

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.

Drug: Normal saline; Device: On-Q ® elastomeric pump

Interventions

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.

Also known as: Naropin

Ropivacaine 0.1%

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.

Also known as: Naropin

Ropivacaine 0.2%

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.

Normal Saline

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.

Also known as: On-Q PainBuster

Normal Saline; Ropivacaine 0.1%; Ropivacaine 0.2%

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Ropivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

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.

Results Point of Contact

• Title: Katherine Egan
• Organization: Emory University

kfegan@emory.edu

404-727-8463

Study Officials

• James Dolak, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: October 19, 2015
• Study Start: July 1, 2015
• Primary Completion: July 25, 2019
• Study Completion: July 25, 2019
• Last Updated: October 14, 2020
• Results First Posted: August 12, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)