Opioid Reduced Regimen for Postoperative Pain

Overseen By Carla M. Edwards

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Must not be taking: Opioids

Disqualifiers: Chronic pain, Substance use, Diabetes, others

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

170 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to manage pain after hip surgery by reducing the number of opioid pills prescribed. The study compares two groups: one receives fewer opioids and more non-opioid medications like Tylenol and gabapentin (part of the opioid-reduced regimen), while the other receives the usual amount of opioids. The goal is to determine if the reduced opioid plan can still effectively control pain. The trial seeks adults undergoing hip arthroscopy who haven't recently used opioids and are open to trying a new pain management plan. As an unphased trial, it offers a unique opportunity to explore innovative pain management strategies that could enhance recovery experiences.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, since the trial is for opioid-naive patients, you should not be taking opioids within 6 weeks prior to surgery.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that gabapentin, when used in a plan with fewer opioids, can help manage post-surgical pain and may reduce the need for opioids. One study found that patients taking gabapentin experienced less pain in the first 24 hours after surgery, indicating its effectiveness in pain reduction.

Gabapentin is generally well-tolerated, with most people not experiencing serious side effects. Common side effects might include dizziness or drowsiness, but these are usually mild and resolve on their own.

Tylenol (acetaminophen) is also commonly used for pain relief and is generally safe when taken as directed. Combining fewer opioid pills with gabapentin and Tylenol aims to manage pain effectively while reducing the risk of opioid-related side effects.

Overall, while no treatment is without risk, research supports using gabapentin and Tylenol with fewer opioids as a generally safe approach to managing post-surgical pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the opioid reduced regimen for postoperative pain because it aims to significantly cut down the use of oxycodone by 50% compared to standard treatments, which typically involve higher doses of opioids like Norco (hydrocodone-acetaminophen). This regimen includes Tylenol and gabapentin, which are non-opioid alternatives, offering pain relief while potentially reducing the risk of opioid dependency and side effects. By integrating these medications, the treatment could provide effective pain management with fewer opioids, a promising advancement in addressing the opioid crisis and enhancing patient recovery post-surgery.

What evidence suggests that this trial's treatments could be effective for postoperative pain?

Research has shown that gabapentin can greatly reduce the need for opioids after surgery. One study found that people used 35% fewer opioids in the first 24 hours when they took gabapentin. Another study showed that gabapentin lowered pain levels by an average of 1.04 points during the same period. In this trial, participants in the experimental group will receive a pain management plan using gabapentin, Tylenol, and fewer Norco pills, aiming to effectively control pain while reducing opioid use. This approach supports the goals of managing pain well and minimizing opioid consumption. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 who speak English, have not taken opioids in the last 6 weeks, and are undergoing their first hip arthroscopy. They must consent to participate and be opioid-naive. People with severe joint damage, prior infections, substance use disorders, certain chronic diseases or pain conditions, previous surgery on the same joint, or a recent history of cancer cannot join.

Inclusion Criteria

English speaking

Written and informed consent for study participation

I haven't taken any opioid medications in the last 6 weeks.

Exclusion Criteria

I regularly use opioids without severe side effects.

I have conditions like rheumatism, diabetes, thyroid issues, depression, or anxiety.

I am scheduled for or have had a revision surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Randomization and Surgery

Participants are randomized to a postoperative pain management protocol and undergo hip arthroscopy

1 day

1 visit (in-person)

Postoperative Treatment

Participants follow their assigned pain management protocol, including medication and documentation of pain levels and medication use

4 weeks

Daily self-reporting

Follow-up

Participants are monitored for safety and effectiveness, with follow-up visits at 1, 3, 6, and 12 months postoperatively

12 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Opioid reduced regimen

Trial Overview

The study compares two post-surgery pain management plans after primary hip arthroscopy: one group receives a reduced number of opioid pills plus gabapentin and Tylenol; the other gets a standard regimen with more opioids. Patients will be randomly assigned to either group after giving consent.

How Is the Trial Designed?

Group I: Experimental Group - Opioid Reduced Experimental Treatment 1 Intervention

Experimental - opioid reduced: 50% less oxycodone relative to control group * Tylenol extra strength (1000 mg, three times daily for 10 days following surgery) * Gabapentin (300 mg at night for 10 days following surgery) * Norco (hydrocodone-acetaminophen) 5mg-325mg, 5 total pills The following non-opioid medications are standard of care at our practice following hip arthroscopy and, thus, will be prescribed to patients regardless of the group they are randomized to: aspirin (325 mg, two times daily for 30 days) and Indocin (75 mg extended release, one time daily for 10 days).

Group II: Control Group Placebo Group 1 Intervention

Control Group will receive the following pain medication regimen: \- Norco (hydrocodone-acetaminophen) 5mg-325mg, 30 total pills The following non-opioid medications are standard of care at our practice following hip arthroscopy and, thus, will be prescribed to patients regardless of the group they are randomized to: aspirin (325 mg, two times daily for 30 days) and Indocin (75 mg extended release, one time daily for 10 days).

Opioid reduced regimen is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Neurontin for:

• Seizures
• Neuropathic pain
• Postherpetic neuralgia

Approved in European Union as Gabapentin for:

• Epilepsy
• Neuropathic pain

Approved in Canada as Gabapentin for:

• Seizures
• Neuropathic pain

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Published Research Related to This Trial

In a study involving 410 patients undergoing various surgeries, perioperative gabapentin did not significantly affect the time to pain resolution after surgery, indicating it may not be effective for immediate postoperative pain management.

However, gabapentin did lead to a 24% increase in the rate of opioid cessation post-surgery, suggesting it could help reduce reliance on opioids after operations, which is important for preventing chronic opioid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Perioperative Gabapentin on Postoperative Pain Resolution and Opioid Cessation in a Mixed Surgical Cohort: A Randomized Clinical Trial. Hah, J., Mackey, SC., Schmidt, P., et al.[2022]

This systematic review and meta-analysis will evaluate the effectiveness of gabapentinoids (pregabalin and gabapentin) in managing postoperative pain compared to other analgesics or placebo, focusing on pain intensity within the first 12 hours after surgery.

The study aims to clarify the role of gabapentinoids in reducing opioid use and associated adverse effects, providing high-quality evidence to support their use in multimodal analgesia regimens for postoperative patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative use of gabapentinoids for the management of postoperative acute pain: protocol of a systematic review and meta-analysis. Verret, M., Lauzier, F., Zarychanski, R., et al.[2023]

In a study of over 967,000 older patients undergoing major surgery, perioperative use of gabapentin was linked to a higher risk of delirium (28% increase), new antipsychotic use, and pneumonia, indicating potential safety concerns for this age group.

Despite these risks, there was no significant difference in in-hospital death rates between gabapentin users and nonusers, suggesting that while gabapentin may help with pain management, its use in older patients requires careful consideration of the associated risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative Gabapentin Use and In-Hospital Adverse Clinical Events Among Older Adults After Major Surgery. Park, CM., Inouye, SK., Marcantonio, ER., et al.[2023]

In a study of 35 patients undergoing functional endoscopic sinus surgery, gabapentin did not significantly reduce post-operative pain or opioid consumption compared to a placebo, indicating it may not be effective for this specific procedure.

The results showed that many patients (15 out of 35) did not require any post-operative opioids, suggesting that routine opioid prescriptions after such surgeries could be minimized, which may help address concerns about opioid misuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gabapentin and postoperative pain and opioid consumption: A double-blind randomized controlled trial of perioperative pain management for sinus surgery. Lerner, DK., Gray, M., Liu, K., et al.[2023]

In a study of 52 patients undergoing lower extremity orthopedic surgery, preemptive oral Gabapentin (600 mg) significantly reduced total opioid consumption in the first 24 hours post-surgery, with an average of 74.13 mg in the Gabapentin group compared to 123.53 mg in the control group (p = 0.001).

Gabapentin also led to lower pain scores on the Visual Analogue Scale (VAS) at 2 hours (1.23 vs. 2.12, p=0.04) and 24 hours (2.19 vs. 2.77, p=0.02) postoperatively, while showing minimal sedation effects comparable to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Preemptive Gabapentin for Lower Extremity Orthopedic surgery under Subarachnoid Block. Hamal, PK., Shrestha, AB., Shrestha, RR.[2022]

In a study of 682 adolescent patients undergoing posterior spinal fusion for idiopathic scoliosis, the addition of gabapentin to pain management protocols significantly reduced opioid use without affecting the length of hospital stay or average pain scores during the first three postoperative days.

While gabapentin-containing protocols were effective in lowering opioid consumption, the variability in results across different sites makes it challenging to determine the exact impact of gabapentin on overall outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of gabapentin on length of stay, opioid use, and pain scores in posterior spinal fusion for adolescent idiopathic scoliosis: a retrospective review across a multi-hospital system. Zhang, DA., Brenn, B., Cho, R., et al.[2023]

A review of 90 trials (31 for pregabalin and 59 for gabapentin) showed that only 24% adequately reported adverse events (AEs) at specified perioperative time points, highlighting a significant gap in safety assessment in post-operative pain treatment studies.

Only 7 out of 10 recommendations from the CONSORT Extension for Harms were typically followed, with 18% of trials not describing their AE assessment methods, indicating a need for improved reporting standards to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event assessment and reporting in trials of newer treatments for post-operative pain. Hoffer, D., Smith, SM., Parlow, J., et al.[2018]

In a study of 50 patients undergoing spinal surgery, preoperative administration of 1,200 mg of gabapentin significantly reduced pain scores in the first 4 hours post-surgery compared to a placebo group.

Patients taking gabapentin also consumed much less morphine (16.3 mg) than those on placebo (42.8 mg), and experienced fewer side effects like vomiting and urinary retention, highlighting gabapentin's potential to enhance postoperative pain management and reduce opioid-related complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic effects of gabapentin after spinal surgery. Turan, A., Karamanlioğlu, B., Memiş, D., et al.[2022]

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Seventy-two hours of perioperative gabapentin use may promote opioid cessation after surgery and decrease the duration of postoperative opioid use.

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Postoperative pain control aims to reduce the negative consequences of acute postsurgical pain and help the patient transition smoothly back to normal function.

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