900 Participants Needed

Pain Medication for Postoperative Pain

(CARES Trial)

Recruiting at 4 trial locations
KD
SH
SC
Overseen BySarah Clark, BA
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Michigan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you have not used significant pain medications like opioids or NSAIDs recently. If you've used these medications frequently in the past 30 days, you may not be eligible to participate.

What data supports the effectiveness of the drugs used for postoperative pain management?

Research shows that non-steroidal anti-inflammatory drugs (NSAIDs) and acetaminophen are effective for managing postoperative pain, often reducing the need for opioids, which can have more side effects. Combining these drugs with opioids can improve pain relief and reduce opioid-related side effects like nausea and sedation.12345

Is ketorolac safe for managing postoperative pain?

Ketorolac, a nonsteroidal anti-inflammatory drug (NSAID), is generally considered safe for short-term use in managing postoperative pain, with minimal risk of serious side effects like kidney issues, bleeding, or stomach problems when used appropriately.678910

How is the drug combination of NSAIDs and opioids unique for postoperative pain management?

This drug combination is unique because it uses both NSAIDs and opioids to manage postoperative pain, aiming to reduce the amount of opioids needed while still providing effective pain relief. This approach helps minimize the risk of opioid-related side effects and the potential for chronic pain development.15111213

What is the purpose of this trial?

This trial is being completed to compare two commonly used options to treat pain after surgery. Participants that undergo gallbladder removal, hernia repair, and breast lump removal will be eligible to enroll. Eligible participants will be randomized to 1 of 2 groups of medications (Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) plus acetaminophen or low dose opioids plus acetaminophen).It is anticipated that the NSAID group will have superior clinical outcomes and fewer side effects when compared to the opioid group.

Research Team

MB

Mark Bicket, MD

Principal Investigator

University of Michigan

Eligibility Criteria

The CARES trial is for patients having low-risk surgeries like gallbladder removal, hernia repair, or breast lump removal. They must not have used significant pain medication recently and should be free from other surgeries or life-threatening conditions in the next 6 months. Those with specific allergies to NSAIDs, opioids, or acetaminophen can't join.

Inclusion Criteria

I haven't used strong painkillers or NSAIDs much before surgery.
I am having a low-risk surgery like gallbladder removal, hernia repair, or breast lumpectomy.

Exclusion Criteria

I do not expect to have any surgeries in the next 6 months and believe I will live longer than 6 months.
I am not allergic or unable to take NSAIDs, opioids, or acetaminophen.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either NSAIDs plus acetaminophen or low dose opioids plus acetaminophen for pain management post-surgery

7 days
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain intensity and adverse events

6 months
Multiple visits (in-person and virtual)

Long-term follow-up

Participants are monitored for chronic pain and healthcare utilization related to pain

180 days post surgery

Treatment Details

Interventions

  • Acetaminophen
  • NSAID
  • Opioid
Trial Overview This study compares two pain management strategies after surgery: one group will receive NSAIDs plus acetaminophen while the other gets low-dose opioids plus acetaminophen. Patients are randomly assigned to these groups to see which has better outcomes and fewer side effects.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Opioid regimenExperimental Treatment2 Interventions
Group II: NSAID regimenExperimental Treatment2 Interventions
Surgical teams will elect for one of the medications within the treatment arm to which the patient is randomized.

NSAID is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺
Approved in European Union as NSAIDs for:
  • Pain relief
  • Inflammation
  • Fever reduction
  • Postoperative pain management
🇺🇸
Approved in United States as NSAIDs for:
  • Pain relief
  • Inflammation
  • Fever reduction
  • Postoperative pain management
  • Arthritis
  • Menstrual cramps
🇨🇦
Approved in Canada as NSAIDs for:
  • Pain relief
  • Inflammation
  • Fever reduction
  • Postoperative pain management
🇯🇵
Approved in Japan as NSAIDs for:
  • Pain relief
  • Inflammation
  • Fever reduction
🇨🇳
Approved in China as NSAIDs for:
  • Pain relief
  • Inflammation
  • Fever reduction
🇨🇭
Approved in Switzerland as NSAIDs for:
  • Pain relief
  • Inflammation
  • Fever reduction
  • Postoperative pain management

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+

Findings from Research

Postoperative pain is common and can lead to chronic pain if not treated effectively; multimodal analgesia, including NSAIDs and opioids, is recommended to manage this pain safely.
The combination of dexketoprofen and tramadol is highlighted as a particularly effective and safe option for postoperative pain control, helping to minimize opioid use and reduce the risk of persistent pain.
New Insights Into the Pharmacological Management of Postoperative Pain: A Narrative Review.Mayoral Rojals, V., Charaja, M., De Leon Casasola, O., et al.[2022]
Postoperative therapy with NSAIDs after tonsillectomy may lead to a higher rate of reoperations, suggesting that their use should be approached with caution.
COX-2 inhibitors combined with intravenous opioids enhance recovery and functional outcomes after knee replacement surgery, indicating a beneficial approach for pain management in this context.
[New insights in postoperative pain therapy].Brack, A., Böttiger, BW., Schäfer, M.[2006]
A multimodal approach to pain control after orthopedic surgery, which includes nonopioid agents like intravenous acetaminophen and intranasal ketorolac, offers better pain relief with fewer side effects compared to using opioids alone.
This review highlights the importance of incorporating newer nonopioid medications alongside established treatments like ketamine and gabapentinoids to enhance analgesia, especially in the context of the ongoing opioid epidemic.
Updates on Multimodal Analgesia for Orthopedic Surgery.Pitchon, DN., Dayan, AC., Schwenk, ES., et al.[2018]

References

New Insights Into the Pharmacological Management of Postoperative Pain: A Narrative Review. [2022]
[New insights in postoperative pain therapy]. [2006]
Updates on Multimodal Analgesia for Orthopedic Surgery. [2018]
Efficacy of nonsteroidal anti-inflammatory drugs in the management of postoperative pain. [2022]
Post-operative analgesic effects of paracetamol, NSAIDs, glucocorticoids, gabapentinoids and their combinations: a topical review. [2022]
Perioperative single dose ketorolac to prevent postoperative pain: a meta-analysis of randomized trials. [2022]
Ketorolac for postoperative pain in children. [2022]
Ketorolac in the era of cyclo-oxygenase-2 selective nonsteroidal anti-inflammatory drugs: a systematic review of efficacy, side effects, and regulatory issues. [2022]
Are NSAIDs Safe? Assessing the Risk-Benefit Profile of Nonsteroidal Anti-inflammatory Drug Use in Postoperative Pain Management. [2021]
Single-dose intravenous ibuprofen for acute postoperative pain in adults. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Celecoxib significantly reduces opioid use after shoulder arthroplasty. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Recent management advances in acute postoperative pain. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Ketoprofen produces modality-specific inhibition of pain behaviors in rats after plantar incision. [2022]
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