Post-operative PainNCT05131178
Post-operative Cesarean Trial of Pain Control
A study testing ON-Q Pump® with continuous infusion of bupivacaine and ON-Q Pump® with continuous infusion of saline in people with Post-operative Pain and Cesarean Section, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study plans to learn more about postoperative pain management after cesarean deliveries (C-sections). As a part of standard of care, the Children's Hospital Colorado's Colorado Fetal Care Center (CFCC) follows the standard Enhanced Recovery After Cesarean (ERAC) guidelines to manage pain following C-section… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Post-operative Pain, Cesarean Section
- What is being tested?
- ON-Q Pump® with continuous infusion of bupivacaine and ON-Q Pump® with continuous infusion of saline
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2021to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant patients 18 years of age or older
- Patients undergoing both scheduled and unscheduled cesarean deliveries at CFCC
Who cannot join
- Active substance abuse (ex methamphetamines) determined by patient report, toxin screen, or screening physician's determination
- Current treatment for chronic pain involving opiate receptor agonism or antagonism (i.e. suboxone, methadone, naltrexone, oxycodone)
- Contraindication to neuraxial anesthesia
- Known allergies to common anesthetic medications
- Inability to consent to study procedures
- Patient receiving general anesthesia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Deion Pena contact
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80011
Liz Torres, 720-777-1661, Elizabeth.Torres@childrenscolorado.org
About this study
Official title: Double Blind Randomized Trial of Post-operative Cesarean Continuous Infusion of Bupivacaine Versus Placebo for Local Incisional Pain Control
This study plans to learn more about postoperative pain management after cesarean deliveries (C-sections). As a part of standard of care, the Children's Hospital Colorado's Colorado Fetal Care Center (CFCC) follows the standard Enhanced Recovery After Cesarean (ERAC) guidelines to manage pain following C-section delivery. In addition, the CFCC uses an FDA approved medical device called the ON-Q ® Pump, which continuously delivers local anesthetic medication to control pain in the area of your procedure. The local anesthetic used is bupivacaine, which is FDA approved for use to control local pain after C-sections. The CFCC has found a significant reduction in opioid use after adopting both of these procedures. The study aims to determine if the ERAC protocol or ON-Q ® Pump continuous infusion is responsible for lower opioid use by comparing bupivacaine (treatment) versus saline (placebo) groups.
- Conditions
- Post-operative Pain, Cesarean Section
- Being tested
- ON-Q Pump® with continuous infusion of bupivacaine, ON-Q Pump® with continuous infusion of saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ON-Q Pump® with continuous infusion of bupivacaineDevice
270 ml of 0.5 % bupivacaine. The device being used is a fixed flow pump meaning the rate of 2 mL/hour. The pump is connected to the catheter and left in place for up to 4 post-operative days or until the completion of the infusion.
ON-Q Pump® with continuous infusion of salineDevice
270 mL of normal saline. The device being used is a fixed flow pump meaning the rate of 2 mL/hour. The pump is connected to the catheter and left in place for up to 4 post-operative days or until the completion of the infusion.
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | ON-Q Pump® with continuous infusion of saline (270 mL of normal saline) Receives: Device: ON-Q Pump® with continuous infusion of saline |
| Bupivacaine | Experimental | ON-Q Pump® with continuous infusion of bupivacaine (270 ml of 0.5 % bupivacaine) Receives: Device: ON-Q Pump® with continuous infusion of bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total postoperative opioid use
Total postoperative opioid use in morphine equivalents through discharge
Measured: Post-operative day 4
Secondary outcomes (16)
Patient satisfaction survey with Visual Analog Scale (VAS) Pain Score
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).
Measured: At hospital discharge (about post-operative day 5)
Antiemetic use at Baseline
Daily antiemetic use by number of doses through discharge
Measured: Baseline
Antiemetic use at post-operative day 1
Daily antiemetic use by number of doses through discharge
Measured: Post-operative day 1
Antiemetic use at post-operative day 2
Daily antiemetic use by number of doses through discharge
Measured: Post-operative day 2
Antiemetic use at post-operative day 3
Daily antiemetic use by number of doses through discharge
Measured: Post-operative day 3
Antiemetic use at post-operative day 4
Daily antiemetic use by number of doses through discharge
Measured: Post-operative day 4
Antiemetic use at hospital discharge (about post-operative day 5)
Daily antiemetic use by number of doses through discharge
Measured: At hospital discharge (about post-operative day 5)
Visual Analog Scale (VAS) Pain Score at Baseline
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).
Measured: Baseline
Visual Analog Scale (VAS) Pain Score at post-operative day 1
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).
Measured: Post-operative day 1
Visual Analog Scale (VAS) Pain Score at post-operative day 2
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).
Measured: Post-operative day 2
Visual Analog Scale (VAS) Pain Score at post-operative day 3
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).
Measured: Post-operative day 3
Visual Analog Scale (VAS) Pain Score at post-operative day 4
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).
Measured: Post-operative day 4
Time to advance to regular diet
Time to advance to regular diet through discharge
Measured: Up to post-operative day 4
Time to first ambulation
Time to first ambulation
Measured: Up to post-operative day 4
Return on bowel function
Return on bowel function (pass gas or bowel movement)
Measured: Up to post-operative day 4
Edinburgh Depression scale at hospital discharge (about post-operative day 5)
The 10-item Edinburgh Depression Scale (EDS) measures depressive symptoms. It includes three sub-scales: anhedonia, anxiety and depression. Possible total scores range from 0 to 30, with higher scores indicating more depressive symptoms and a worse outcome.
Measured: At hospital discharge (about post-operative day 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start7 Nov 2021
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Avanos Medical, Children's Hospital Colorado, Colorado Fetal Care Center
- Responsible party
- Sponsor
- Investigators
- Michael Zaretsky, MD, Principal investigator, Children's Hospital Colorado - Colorado Fetal Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131178
- Sponsor's protocol ID
- 21-2810
- Status last verified
- Feb 2026
- First submitted
- 10 Nov 2021
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Randomized Trial of Post-operative Cesarean Continuous Infusion of Bupivacaine Versus Placebo for Local Incisional Pain Control
- ClinicalTrials.gov ID
- NCT05131178
- Acronym / sponsor ID
- 21-2810
- Conditions
- Post-operative Pain, Cesarean Section
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Avanos Medical, Children's Hospital Colorado, Colorado Fetal Care Center
- Study start
- 7 Nov 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study plans to learn more about postoperative pain management after cesarean deliveries (C-sections). As a part of standard of care, the Children's Hospital Colorado's Colorado Fetal Care Center (CFCC) follows the standard Enhanced Recovery After Cesarean (ERAC) guidelines to manage pain following C-section delivery. In addition, the CFCC uses an FDA approved medical device called the ON-Q ® Pump, which continuously delivers local anesthetic medication to control pain in the area of your procedure. The local anesthetic used is bupivacaine, which is FDA approved for use to control local pain after C-sections. The CFCC has found a significant reduction in opioid use after adopting both of these procedures. The study aims to determine if the ERAC protocol or ON-Q ® Pump continuous infusion is responsible for lower opioid use by comparing bupivacaine (treatment) versus saline (placebo) groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline | Placebo comparator | Device: ON-Q Pump® with continuous infusion of salineON-Q Pump® with continuous infusion of saline (270 mL of normal saline) |
| Bupivacaine | Experimental | Device: ON-Q Pump® with continuous infusion of bupivacaineON-Q Pump® with continuous infusion of bupivacaine (270 ml of 0.5 % bupivacaine) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant patients 18 years of age or older
- Patients undergoing both scheduled and unscheduled cesarean deliveries at CFCC
Key exclusion criteria (6 listed)
- Active substance abuse (ex methamphetamines) determined by patient report, toxin screen, or screening physician's determination
- Current treatment for chronic pain involving opiate receptor agonism or antagonism (i.e. suboxone, methadone, naltrexone, oxycodone)
- Contraindication to neuraxial anesthesia
- Known allergies to common anesthetic medications
- Inability to consent to study procedures
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 |
|---|---|---|
| ON-Q Pump® with continuous infusion of bupivacaine270 ml of 0.5 % bupivacaine. The device being used is a fixed flow pump meaning the rate of 2 mL/hour. The pump is connected to the catheter and left in place for up to 4 post-operative days or until the completion of the infusion. | Device | Bupivacaine |
| ON-Q Pump® with continuous infusion of saline270 mL of normal saline. The device being used is a fixed flow pump meaning the rate of 2 mL/hour. The pump is connected to the catheter and left in place for up to 4 post-operative days or until the completion of the infusion. | Device | Saline |
Primary outcome
Total postoperative opioid use
Time frame: Post-operative day 4
Total postoperative opioid use in morphine equivalents through discharge
16 secondary outcomes
Patient satisfaction survey with Visual Analog Scale (VAS) Pain Score
Time frame: At hospital discharge (about post-operative day 5)
Antiemetic use at Baseline
Time frame: Baseline
Antiemetic use at post-operative day 1
Time frame: Post-operative day 1
Antiemetic use at post-operative day 2
Time frame: Post-operative day 2
Antiemetic use at post-operative day 3
Time frame: Post-operative day 3
Antiemetic use at post-operative day 4
Time frame: Post-operative day 4
Antiemetic use at hospital discharge (about post-operative day 5)
Time frame: At hospital discharge (about post-operative day 5)
Visual Analog Scale (VAS) Pain Score at Baseline
Time frame: Baseline
Visual Analog Scale (VAS) Pain Score at post-operative day 1
Time frame: Post-operative day 1
Visual Analog Scale (VAS) Pain Score at post-operative day 2
Time frame: Post-operative day 2
Visual Analog Scale (VAS) Pain Score at post-operative day 3
Time frame: Post-operative day 3
Visual Analog Scale (VAS) Pain Score at post-operative day 4
Time frame: Post-operative day 4
Time to advance to regular diet
Time frame: Up to post-operative day 4
Time to first ambulation
Time frame: Up to post-operative day 4
Return on bowel function
Time frame: Up to post-operative day 4
Edinburgh Depression scale at hospital discharge (about post-operative day 5)
Time frame: At hospital discharge (about post-operative day 5)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- 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.
Deion Pena contact
Michael Zaretsky, MD principal investigator
Children's Hospital Colorado - Colorado Fetal Care Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ON-Q Pump® with continuous infusion of bupivacaine and ON-Q Pump® with continuous infusion of saline in people with Post-operative Pain and Cesarean Section, run by University of Colorado, Denver 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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 6 Feb 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Manager (720-777-7080, Kaylene.Ross@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total postoperative opioid use (time frame: Post-operative day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2026.