PainPhase 4NCT02579629

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

A Phase 4 study testing Ropivacaine 0.1%, Ropivacaine 0.2% and Normal saline in people with Pain, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Pain
What is being tested?: Ropivacaine 0.1%, Ropivacaine 0.2% and Normal saline
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteUnited States
Study dates: Jul 2015to 25 Jul 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

Patients with maternal history of narcotic abuse or dependency
Patient with pre-operative fever (>100.4 degrees F)
Patients less than 18 years old

Trial locations and contacts

1 site in 1 country.

United States1 site

Emory University Hospital Midtown
Atlanta, Georgia, 30308

Other trials in United States

About this study

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

Read the 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.

Conditions: Pain
Being tested: Ropivacaine 0.1%, Ropivacaine 0.2%, Normal saline, On-Q ® elastomeric pump
Keywords: Analgesia, Cesarean section, Opiates
Medical subject headings: Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ropivacaine 0.1%Drug
Also called Naropin
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.
Ropivacaine 0.2%Drug
Also called Naropin
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 salineDrug
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 pumpDevice
Also called On-Q PainBuster
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.

Study groups in NCT02579629
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Drug: Normal saline; Device: On-Q ® elastomeric pump

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 post-operatively, 72 hours post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 201525 Jul 2019

First posted19 Oct 2015 (estimated)
Study startJul 2015
Primary completion25 Jul 2019
Study completion25 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PainStudies of the same condition, open and under way.
More trials run by Emory UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02579629
Sponsor's protocol ID: IRB00073292
Status last verified: Sep 2020
First submitted: 25 Aug 2015
Last updated: 14 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02579629
Acronym / sponsor ID: IRB00073292
Conditions: Pain
Keywords: Analgesia, Cesarean section, Opiates
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Study start: Jul 2015
Primary completion: 25 Jul 2019 (actual)
Study completion: 25 Jul 2019 (actual)
First posted: 19 Oct 2015 (estimated)
Results: Posted 12 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Ropivacaine 0.1%	Active comparator	Drug: Ropivacaine 0.1%, Device: On-Q ® elastomeric pumpSubjects 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	Drug: Ropivacaine 0.2%, Device: On-Q ® elastomeric pumpSubjects 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	Drug: Normal saline, Device: On-Q ® elastomeric pumpSubjects 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ropivacaine 0.1%Also: NaropinRopivacaine 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.	Drug	Ropivacaine 0.1%
Ropivacaine 0.2%Also: NaropinRopivacaine 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.	Drug	Ropivacaine 0.2%
Normal salineNormal 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.	Drug	Normal Saline
On-Q ® elastomeric pumpAlso: On-Q PainBusterThe 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.	Device	Normal Saline, Ropivacaine 0.1%, Ropivacaine 0.2%

Primary outcome

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.
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.
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.
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.
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.
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.

8 secondary outcomes

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
Breastfeeding Success
Time frame: 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
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
Cost Analysis
Time frame: At the time of hospital discharge (average of 3 days)
Patient Satisfaction at 72 Hours Post Intervention
Time frame: 72 hours post-operatively
Dosing Amount of Non-steroidal Anti-inflammatory Drugs
Time frame: 24 post-operatively, 72 hours post-operatively
Amount of Opioid Use
Time frame: 24 post-operatively, 72 hours post-operatively

Results and safety

Results posted to the registry on 12 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ropivacaine 0.1%	22	20
Ropivacaine 0.2%	20	19
Normal Saline	22	20

Primary outcome: Change in Pain Scores During Cough From Baseline

Time frame: 2 hours post baseline, 6, 12, 24, 48, 72 hours post baseline. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Ropivacaine 0.1% n = 20	Ropivacaine 0.2% n = 19	Normal Saline n = 20
Change in score at 2-hours post baseline	4 (0 to 15)	1 (-4.5 to 18.5)	20.5 (4.75 to 36.25)
Change in score at 6-hours post baseline	10 (4 to 27)	3 (-8 to 10)	10.5 (3.75 to 30.75)
Change in score at 12-hours post baseline	14.5 (4 to 26)	2 (-4 to 13)	15.5 (9.75 to 41.25)
Change in score at 24-hours post baseline	20 (1.5 to 45.5)	27 (0 to 36)	15.5 (9.75 to 41.25)
Change in score at 48-hours post baseline	13 (6.5 to 39.75)	2 (-2.5 to 26.5)	15 (-0.5 to 35.75)
Change in score at 72-hours post baseline	6.5 (-1.5 to 32.25)	0 (0 to 20)	3 (-1.5 to 15)

Population analysed: 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.

Primary outcome: 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. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Ropivacaine 0.1% n = 20	Ropivacaine 0.2% n = 19	Normal Saline n = 20
Change in score at 2-hours post baseline	4 (1.5 to 12.5)	5 (0 to 17.5)	10.5 (1.75 to 31)
Change in score at 6-hours post baseline	8 (1 to 18)	0 (-2 to 6.5)	5 (0.75 to 19.5)
Change in score at 12-hours post baseline	-6.5 (-22.5 to 0)	0 (-2.5 to 1.5)	-6.5 (-28.5 to 0)
Change in score at 24-hours post baseline	9 (0.75 to 23.75)	0 (0 to 21.25)	16 (0.75 to 29)
Change in score at 48-hours post baseline	9.5 (0.75 to 21.25)	3 (0 to 22.5)	17 (0.75 to 27)
Change in score at 72-hours post baseline	1 (-3 to 8.25)	3 (0 to 10)	2.5 (0 to 12)

Primary outcome: Change in Intensity of Pain: Numerical Pain Scale (NPS) From Baseline

Time frame: 6 weeks, 3 months. Median (Inter-Quartile Range). Unit: units on a scale

Measure	Ropivacaine 0.1% n = 17	Ropivacaine 0.2% n = 19	Normal Saline n = 17
Change at 6 weeks post intervention	3 (0 to 5)	2 (0 to 4)	5 (2.5 to 6.5)
Change at 3 months post intervention	0 (0 to 3)	0 (0 to 0)	0 (0 to 0.75)

Population analysed: The difference reflects the number of patients who were lost to follow up at 6 weeks and 3 months.

Primary outcome: Change in Intensity of Pain: VAPS From Baseline

Time frame: 24 hours post-intervention, 48 hrs, and 72hr post-intervention.. Median (Inter-Quartile Range). Unit: units on a scale

Measure	Ropivacaine 0.1% n = 20	Ropivacaine 0.2% n = 19	Normal Saline n = 20
Change in score at 24 hours post intervention	0 (0 to 5.75)	0 (0 to 13)	0 (0 to 44.5)
Change in score at 48 hours post intervention	0 (0 to 11.25)	0 (0 to 13.5)	0 (0 to 12.28)
Change in score at 72 hours post intervention	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)

Population analysed: 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.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Evens were collected during follow up time (Up to 3 months post intervention).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ropivacaine 0.1%	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Ropivacaine 0.2%	0 of 19 (0%)	0 of 19 (0%)	0 of 19
Normal Saline	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James Dolak, MD principal investigator

Emory University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ropivacaine 0.1%, Ropivacaine 0.2% and Normal saline in people with Pain, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain Scores During Cough From Baseline (time frame: 2 hours post baseline, 6, 12, 24, 48, 72 hours post baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02579629.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.