Nonopioid Pain Medication for Post-Surgical Hip Pain

Recruiting at 2 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Must not be taking: Narcotics

Disqualifiers: Alcohol abuse, Pregnancy, Renal impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

188 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if pain after hip surgery can be controlled without narcotic pain medications like Oxycodone. The study compares a standard pain treatment using Oxycodone to a non-opioid regimen, which includes medicines like Ibuprofen and Acetaminophen. Individuals scheduled for hip arthroscopy at Mayo Clinic, who haven't used narcotics in the past six months and don't have certain allergies, might be suitable candidates. As a Phase 4 trial, this research explores how an already FDA-approved and effective treatment benefits more patients, contributing to broader pain management strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude people who have used narcotics in the past 6 months.

What is the safety track record for these treatments?

Research has shown that a pain control plan using ibuprofen, gabapentin, acetaminophen, and methocarbamol is generally well-tolerated by most people. Gabapentin, in particular, significantly reduces the need for opioid painkillers after surgery, benefiting those who wish to avoid narcotics. Methocarbamol, a muscle relaxant, also helps reduce pain immediately after surgery. While these medications have been used separately for various conditions, their combined use in this plan offers a promising alternative to opioids. Overall, this treatment aims to manage pain effectively while reducing the risk of side effects associated with opioid use. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for post-surgical hip pain, which typically involves opioid medications like Oxycodone, the new non-opioid pain control regimen offers a different approach. This treatment is unique because it combines Ibuprofen, Gabapentin, Acetaminophen, and Methocarbamol to manage pain without the use of opioids. Researchers are excited about this treatment because it targets pain through multiple pathways, potentially reducing the risk of opioid dependence and side effects. This multi-drug regimen could provide effective pain relief while minimizing the negative impacts associated with opioid use.

What evidence suggests that this trial's treatments could be effective for post-surgical hip pain?

Research has shown that non-opioid medications can effectively manage pain after hip surgery. In this trial, participants in the Non-Opiate Pain Control Group will receive a regimen including gabapentin, methocarbamol, acetaminophen, and ibuprofen. One study found that gabapentin reduces the need for opioids after surgery. Another study showed that methocarbamol eases post-surgery pain more effectively than other pain relievers. Additionally, acetaminophen and ibuprofen are known for relieving pain and reducing swelling. This combination of medications offers a comprehensive approach to managing pain from different angles without using narcotics. These findings suggest that non-opioid treatments can effectively control pain after hip surgery. ^{4 5 6 7 8}

Who Is on the Research Team?

Kelechi Okoroha, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals scheduled for a primary hip arthroscopy at Mayo Clinic, Rochester, MN. It's not suitable for those with allergies to pain medications like Motrin or Tylenol, history of substance abuse, recent narcotic use, pregnant women, or people with kidney issues or stomach ulcers.

Inclusion Criteria

I am scheduled for a hip arthroscopy at Mayo Clinic in Rochester, MN.

Exclusion Criteria

I am allergic or intolerant to common pain or inflammation medications.

I have been diagnosed with peptic ulcer disease.

I have had bleeding in my digestive tract.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard of care pain medication or a non-opiate pain control regimen following hip arthroscopy

2 weeks

1 visit (in-person) for surgery, followed by home-based recovery

Follow-up

Participants are monitored for changes in pain score using a visual analog scale

2 weeks

1 visit (in-person) for follow-up assessment

What Are the Treatments Tested in This Trial?

Interventions

• Acetaminophen
• Gabapentin
• Ibuprofen
• Methocarbamol
• Nonopioid Pain Control Regimen
• Oxycodone

Trial Overview The study tests the effectiveness of a non-narcotic pain control regimen after hip surgery using Acetaminophen (Tylenol), Methocarbamol (Robaxin), Oxycodone (a mild opioid), Ibuprofen (Motrin), and Gabapentin.

How Is the Trial Designed?

Group I: Non-Opiate Pain Control Group Experimental Treatment 4 Interventions

Subjects will receive a non-opiate pain control regime using Ibuprofen, Gabapentin, Acetaminophen, Methocarbamol for pain control following hip arthroscopy procedure.

Group II: Standard of Care Group Active Control 1 Intervention

Subjects will receive standard of care pain medication Oxycodone for pain control following hip arthroscopy procedure

Nonopioid Pain Control Regimen is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Nonopioid Pain Management for:

• Pain management after arthroscopic hip procedures
• Mild to moderate pain
• Chronic pain

Approved in European Union as Nonopioid Pain Management for:

• Pain management after surgical procedures
• Mild to moderate pain
• Chronic pain

Approved in Canada as Nonopioid Pain Management for:

• Pain management after surgical procedures
• Mild to moderate pain
• Chronic pain

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

In a study of 100 patients undergoing total hip arthroplasty, a nonnarcotic oral pain management protocol resulted in lower mean pain scores during the first 24 hours post-surgery compared to a traditional narcotic-based protocol.

The nonnarcotic approach not only provided adequate pain control but also significantly reduced opioid consumption and adverse effects, indicating a safer alternative for pain management after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective evaluation of 2 different pain management protocols for total hip arthroplasty. Post, ZD., Restrepo, C., Kahl, LK., et al.[2022]

Nonopioid analgesics, such as paracetamol, NSAIDs, and metamizol, play a crucial role in managing postoperative pain, but their use is often inadequate, leading to poor pain control in many patients.

Recent findings suggest that while paracetamol is less effective than NSAIDs, both nonselective and COX-2 selective NSAIDs show similar efficacy, with COX-2 inhibitors being preferable for short-term use due to their lower adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonopioid analgesics for postoperative pain management. Pogatzki-Zahn, E., Chandrasena, C., Schug, SA.[2022]

Multimodal analgesic regimens, which combine different types of pain relief medications, are effective in preventing periods of inadequate pain control after joint arthroplasty, ensuring better pain management.

Key components of these regimens include acetaminophen, COX-2 inhibitors, gabapentinoids, glucocorticoids, and local anesthetics like bupivacaine, emphasizing the importance of both the timing and mechanism of action for optimal pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closing the Gaps in Postsurgical Pain Management. Scuderi, GR.[2015]

Multimodal pain management strategies that include nonopioid medications can effectively control postoperative pain while reducing the side effects associated with opioid use, which is crucial for patients with opioid dependence or other health issues.

Recent data indicates that nonopioid analgesics have favorable safety profiles, making them a valuable option in contemporary pain management for postoperative patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Nonopioid Analgesics in Perioperative Pain Control. Thomas, DA., West, M., Legler, A., et al.[2019]

Patients with prior opioid use after hand and upper-extremity surgery required significantly more opioid pills (28.8 pills) compared to nonopioid users (14.5 pills) and were less satisfied with their pain control.

Switching to a different opioid reduced the number of pills used by prior opioid users (24.6 pills) compared to those who continued on the same opioid (37.9 pills), indicating that alternative prescribing strategies may help manage postoperative pain more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Pain Management of Non-"Opioid-Naive" Patients Undergoing Hand and Upper-Extremity Surgery. Wong, KA., Goyal, KS.[2021]

Gabapentin has been shown to significantly reduce postoperative pain and opioid consumption in the immediate postoperative period, based on a systematic review of four randomized controlled trials.

The review highlights the importance of gabapentin as a nonopioid analgesic that can enhance patient satisfaction, although further research is needed to strengthen the findings and include diverse patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid-Sparing Anesthesia: Gabapentin and Postoperative Pain. Ladich, EM., Zhou, KQ., Spence, DL., et al.[2023]

In a study of 244 patients undergoing hand and upper-extremity surgery, providing written prescriptions for nonopioids did not significantly impact postoperative pain control or the amount of medication consumed.

Patients who had soft tissue procedures tended to use more nonopioids than opioids after surgery, regardless of whether they received a written prescription, suggesting a preference for nonopioid pain management in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Written Prescription for Over-the-Counter Nonopioid Pain Medications Does Not Increase the Likelihood of Use after Ambulatory Hand and Upper Extremity Surgery. Lynch, DJ., Lin, JS., Goyal, KS.[2022]

A study involving 61 patients who underwent meniscectomy or meniscal repair found that a multimodal nonopioid pain regimen provided equivalent pain control compared to a traditional opioid regimen, with no significant differences in pain levels during the first 10 days post-surgery.

Both pain management strategies resulted in similar patient-reported outcomes and side effects, indicating that nonopioid protocols can be a safe and effective alternative to opioids for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal Nonopioid Pain Protocol Provides Equivalent Pain Versus Opioid Control Following Meniscus Surgery: A Prospective Randomized Controlled Trial. Jildeh, TR., Okoroha, KR., Kuhlmann, N., et al.[2021]

A study of 32,511 opioid-naïve surgical patients showed that the use of multimodal analgesia increased significantly from 2012 to 2018, leading to a decrease in high-risk opioid prescriptions at discharge from 34.1% to 17.7%.

Despite improvements in pain management, about 20% of patients still received high-risk opioid prescriptions, indicating that careful consideration of pre-discharge opioid use and multimodal analgesia is essential for safe prescribing practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association of multimodal analgesia and high-risk opioid discharge prescriptions in opioid-naive surgical patients. Langnas, E., Rodriguez-Monguio, R., Luo, Y., et al.[2023]

In a study of 182 patients undergoing inguinal hernia surgery, intravenous parecoxib resulted in higher patient satisfaction (87%) compared to intravenous propacetamol (70%) for postoperative pain management.

Although parecoxib had a higher average cost per patient (€6.65 vs €5.28 for propacetamol), the incremental cost per additional patient satisfied was only slightly higher (€8.02), suggesting that parecoxib may provide better value in terms of patient satisfaction despite its higher cost.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost analysis applied to postoperative analgesia regimens: a comparison between parecoxib and propacetamol. Tilleul, P., Weickmans, H., Sean, PT., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6942092/

Postoperative Pain Management Strategies in Hip Arthroscopy In a meta-analysis of randomized controlled trials conducted by Han et al., gabapentin significantly reduced postoperative opioid consumption by ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11439489/

Comparative Review of Postoperative Analgesic Use After ... This narrative review examines the comparative efficacy, safety, and implications of using opioids versus non-opioid analgesics in managing postoperative pain ...

3. go.drugbank.com go.drugbank.com/conditions/DBCOND0053819

Hip Arthroscopy (DBCOND0053819) Associated Data ; NCT05076110. Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures. Acetaminophen · Gabapentin · Ibuprofen · Methocarbamol ...

4. researchgate.net researchgate.net/publication/371376681_Association_between_Postoperative_Methocarbamol_and_Postoperative_Pain_Opioid_Dose_Requirements_A_Retrospective_Cohort_Study

Association Between Postoperative Methocarbamol and ... Conclusion The present study showed a higher efficacy of methocarbamol in post-operative pain reduction in comparison to nefopam. No serious ...

5. cureus.com cureus.com/articles/247392-evaluating-the-efficacy-of-methocarbamol-and-nefopam-in-orthopedic-surgical-pain

Evaluating the Efficacy of Methocarbamol and Nefopam in ... The goal of this study was to compare the effectiveness of methocarbamol and nefopam for treating post-operative pain following orthopedic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11216677/

Use of Muscle Relaxants for Acute Postoperative Pain The results showed that methocarbamol resulted in significantly lower pain scores in the immediate postoperative period, but intercostal nerve ...

7. aaos.org aaos.org/globalassets/quality-and-practice-resources/dod/painalleviationcpg.pdf

Pharmacologic, Physical, and Cognitive Pain Alleviation for ... This CPG evaluates therapeutic interventions for pain alleviation, improved function, and less opioid use after musculoskeletal injury or.

8. digitalrepository.unm.edu digitalrepository.unm.edu/cgi/viewcontent.cgi?article=1080&context=unm_jor

Multimodal Analgesia in Orthopaedic Surgery and ... The use of gabapentin has been shown to be more effective in perioperative pain control after lumbar spine procedures,28 however these data are confounded by ...