100 Participants Needed

ON-Q Pump® Pain Control for Post-Cesarean Pain

CR
CR
DP
Overseen ByDeion Pena
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: University of Colorado, Denver
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores better ways to manage pain after C-sections. Researchers are using the ON-Q Pump®, a device that continuously delivers the pain-relieving medication bupivacaine (also known as Marcaine or Sensorcaine). The goal is to determine if this method can reduce the need for opioid painkillers compared to standard recovery guidelines. Participants should be pregnant patients undergoing a C-section at the Colorado Fetal Care Center. As an unphased trial, this study provides a unique opportunity to contribute to innovative pain management solutions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently being treated for chronic pain with certain medications like suboxone, methadone, or oxycodone.

What prior data suggests that the ON-Q Pump® is safe for post-cesarean pain management?

Research shows that bupivacaine is a safe and effective option for managing pain after C-sections. As an FDA-approved local anesthetic, it is considered safe for this use. Studies have found that using bupivacaine during cesarean deliveries helps reduce pain and the need for opioids, which are strong painkillers with serious side effects. Reducing opioid use is beneficial.

In one study, patients who received bupivacaine during surgery reported less pain, indicating its effectiveness and minimal issues. Additionally, when used with the ON-Q Pump, bupivacaine continuously delivers medicine to the needed area, controlling pain with few side effects.

The research and FDA approval for this type of pain control suggest bupivacaine is safe for use in people.12345

Why are researchers excited about this trial?

Researchers are excited about using the ON-Q Pump® with bupivacaine for post-cesarean pain control because it offers a targeted approach that differs from the standard of care, which often involves systemic medications like oral opioids or NSAIDs. This treatment uses a local anesthetic, bupivacaine, delivered directly to the surgical site through a continuous infusion, potentially reducing the need for systemic pain medications and their associated side effects. By directly targeting the pain area, it may provide more effective and consistent pain relief with fewer unwanted side effects compared to traditional options.

What evidence suggests that the ON-Q Pump® is effective for post-cesarean pain management?

Research shows that using bupivacaine with the ON-Q Pump can greatly reduce pain after a C-section. In this trial, participants will receive either bupivacaine or saline through the ON-Q Pump. Studies have found that bupivacaine decreases the need for opioids, which are strong painkillers, after surgery. For example, one study found that using bupivacaine directly in the wound reduces both pain and the need for extra opioid painkillers. Another study confirmed these results, showing that bupivacaine can effectively manage pain and reduce opioid use after a cesarean delivery. This makes bupivacaine with the ON-Q Pump a promising option for better pain control after C-sections.12678

Who Is on the Research Team?

MZ

Michael Zaretsky, MD

Principal Investigator

Children's Hospital Colorado - Colorado Fetal Care Center

Are You a Good Fit for This Trial?

This trial is for pregnant patients aged 18 or older who are undergoing scheduled or unscheduled C-sections at the Colorado Fetal Care Center. It's not for those with chronic pain treatment involving opiates, inability to consent, general anesthesia during delivery, active substance abuse, contraindications to spinal anesthesia, or allergies to anesthetic meds.

Inclusion Criteria

I am having a cesarean delivery at CFCC, planned or emergency.

Exclusion Criteria

I cannot have spinal or epidural anesthesia.
I will be under general anesthesia for a procedure.
You have allergies to commonly used anesthetic medications.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either bupivacaine or saline via the ON-Q Pump for post-operative pain management

Up to 5 days
In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain scores and opioid use

Up to post-operative day 5
In-hospital monitoring

What Are the Treatments Tested in This Trial?

Interventions

  • Bupivacaine
  • ON-Q Pump®
  • Saline

Trial Overview

The study compares two post-C-section pain management methods: one uses the ON-Q Pump® to deliver bupivacaine (a local anesthetic), and the other uses the same pump but with saline (placebo). The goal is to see which method leads to lower opioid use after surgery.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: BupivacaineExperimental Treatment1 Intervention
Group II: SalinePlacebo Group1 Intervention

Bupivacaine is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Marcaine for:
🇪🇺
Approved in European Union as Marcaine for:
🇨🇦
Approved in Canada as Sensorcaine for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

Colorado Fetal Care Center

Collaborator

Trials
1
Recruited
100+

Avanos Medical

Collaborator

Trials
9
Recruited
1,900+

Children's Hospital Colorado

Collaborator

Trials
121
Recruited
5,135,000+

Citations

Analgesic effectiveness of wound infiltration with bupivacaine ...

According to a study by Hussein et al., 89.8% of pain in patients after a cesarean section is moderate to severe. The duration of surgery, the ...

Efficacy of Single Wound Infiltration With Bupivacaine and ...

In this study, wound infiltration with a single administration of bupivacaine and adrenaline during cesarean delivery reduced postoperative pain and opioid use.

Efficacy of Single Wound Infiltration With Bupivacaine and ...

Single wound infiltration with bupivacaine and adrenaline significantly reduced postoperative pain and postpartum use of rescue opioid analgesics.

Improving Pain Management After Cesarean Birth Using ...

Transversus abdominis plane blocks with liposomal bupivacaine can reduce opioid use and pain after cesarean birth, improving recovery.

Evaluation of Bupivacaine Local Infiltration Effect with or ...

The findings of this study indicate that the use of bupivacaine can effectively reduce pain and the need for opioid painkillers in women undergoing cesarean ...

Wound Infiltration With Bupivacaine/Adrenalin During ...

Thus study evaluates the advantage of infiltration of the surgical wound by local anesthetics in cesarean section on post operative pain relief.

Comparing the Effect of Bupivacaine and Ropivacaine in ...

The results suggest that ropivacaine and bupivacaine are two efficient drugs in anesthesia in the cesarean section, ropivacaine is a better choice due to little ...

What efficacy supports the use of liposomal bupivacaine for ...

The primary outcome (11-point pain scores with movement at 48 hours after delivery) was similar in both the liposomal bupivacaine (median 4) and ...