Pain Medication for Postoperative Pain

(CARES Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Mark Bicket, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of Michigan

Must not be taking: Opioids, NSAIDs

Disqualifiers: Other surgery, Life expectancy, others

No Placebo Group

Prior Safety Data

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 5 11 12 13}

Research Team

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.

Trial 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 (Other)
• NSAID (Non-Steroidal Anti-Inflammatory Drug)
• Opioid (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

Group I: Opioid regimen Experimental Treatment 2 Interventions

Group II: NSAID regimen Experimental Treatment 2 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 Canada, Japan, China, Switzerland for the following indications:

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

Research Locations Nearby Select from list below to view details:

Temple University - Temple Health Philadelphia, PA

Washington University in Saint Louis Saint Louis, MO

Henry Ford Health System Detroit, MI

Unity Health Toronto Toronto, Canada

More Trial Locations

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1891

Patients Recruited

6,458,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Patients Recruited

27,110,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Insights Into the Pharmacological Management of Postoperative Pain: A Narrative Review. Mayoral Rojals, V., Charaja, M., De Leon Casasola, O., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New insights in postoperative pain therapy]. Brack, A., Böttiger, BW., Schäfer, M.[2006]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updates on Multimodal Analgesia for Orthopedic Surgery. Pitchon, DN., Dayan, AC., Schwenk, ES., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of nonsteroidal anti-inflammatory drugs in the management of postoperative pain. Moote, C.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-operative analgesic effects of paracetamol, NSAIDs, glucocorticoids, gabapentinoids and their combinations: a topical review. Dahl, JB., Nielsen, RV., Wetterslev, J., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative single dose ketorolac to prevent postoperative pain: a meta-analysis of randomized trials. De Oliveira, GS., Agarwal, D., Benzon, HT.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketorolac for postoperative pain in children. McNicol, ED., Rowe, E., Cooper, TE.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketorolac in the era of cyclo-oxygenase-2 selective nonsteroidal anti-inflammatory drugs: a systematic review of efficacy, side effects, and regulatory issues. Macario, A., Lipman, AG.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are NSAIDs Safe? Assessing the Risk-Benefit Profile of Nonsteroidal Anti-inflammatory Drug Use in Postoperative Pain Management. Chang, RW., Tompkins, DM., Cohn, SM.[2021]

A single study involving 201 participants indicated that intravenous (IV) ibuprofen provided at least 50% pain relief in 32% of patients compared to 22% in the placebo group, suggesting a potential benefit, although the evidence is of very low certainty.

The study found no serious adverse events associated with IV ibuprofen, and the rate of any adverse events was similar between ibuprofen and placebo, indicating that it may be a safe option for postoperative pain management, but further research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-dose intravenous ibuprofen for acute postoperative pain in adults. Ferguson, MC., Schumann, R., Gallagher, S., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Celecoxib significantly reduces opioid use after shoulder arthroplasty. Burns, KA., Robbins, LM., LeMarr, AR., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent management advances in acute postoperative pain. Argoff, CE.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketoprofen produces modality-specific inhibition of pain behaviors in rats after plantar incision. Spofford, CM., Ashmawi, H., Subieta, A., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

New Insights Into the Pharmacological Management of Postoperative Pain: A Narrative Review. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

[New insights in postoperative pain therapy]. [2006]

3. United States pubmed.ncbi.nlm.nih.gov

Updates on Multimodal Analgesia for Orthopedic Surgery. [2018]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy of nonsteroidal anti-inflammatory drugs in the management of postoperative pain. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Post-operative analgesic effects of paracetamol, NSAIDs, glucocorticoids, gabapentinoids and their combinations: a topical review. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Perioperative single dose ketorolac to prevent postoperative pain: a meta-analysis of randomized trials. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Ketorolac for postoperative pain in children. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Ketorolac in the era of cyclo-oxygenase-2 selective nonsteroidal anti-inflammatory drugs: a systematic review of efficacy, side effects, and regulatory issues. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Are NSAIDs Safe? Assessing the Risk-Benefit Profile of Nonsteroidal Anti-inflammatory Drug Use in Postoperative Pain Management. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Single-dose intravenous ibuprofen for acute postoperative pain in adults. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Celecoxib significantly reduces opioid use after shoulder arthroplasty. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Recent management advances in acute postoperative pain. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Ketoprofen produces modality-specific inhibition of pain behaviors in rats after plantar incision. [2022]