Opioid Reduced Regimen for Postoperative Pain

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Rush University Medical Center

Must not be taking: Opioids

Disqualifiers: Chronic pain, Substance use, Diabetes, others

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study will be a prospective, single-blinded, randomized controlled trial (RCT), investigating the influence of the number of opioid pills prescribed following primary hip arthroscopy. All patients who sign the consent form will be enrolled in the suited and randomized to one of the two treatment arms. The intervention group will receive 5 Norco pills, gabapentin (30 mg, once daily for 10 days following surgery), and Tylenol (1000 mg, three times daily for 10 days following surgery) while the control will receive the standard at our practice of 30 Norco pills.

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.

What data supports the idea that Opioid Reduced Regimen for Postoperative Pain (also known as: Opioid reduced regimen, Neurontin, Gabapentin) is an effective treatment?

The available research shows that using gabapentin, a drug in the Opioid Reduced Regimen, can effectively reduce the need for opioids after surgery. For example, one study found that adding gabapentin to pain management protocols for spinal surgery in adolescents helped reduce opioid use and maintain good pain control. Another study on sinus surgery patients also suggested that gabapentin could lower both pain levels and the amount of opioids needed. These findings indicate that gabapentin can be a helpful part of managing pain after surgery, potentially reducing the risks associated with opioid use. ^{1 2 3 4 5}

What safety data exists for using gabapentin in postoperative pain management?

The safety of gabapentin in postoperative pain management has been studied in various contexts. Research indicates that gabapentin is used to reduce opioid consumption in perioperative pain management, but its safety, especially among older adults, remains uncertain. Studies have reviewed its effects on opioid use, pain scores, and length of hospital stay, with mixed results. A review of adverse event reporting in trials highlights the need for better assessment of gabapentin's safety profile. While gabapentinoids are recommended for perioperative use, the evidence supporting their safety is not fully clear. ^{1 2 4 6 7}

Is the drug Opioid reduced regimen (Neurontin, Gabapentin) a promising option for reducing pain after surgery?

Yes, the drug Gabapentin, part of the Opioid reduced regimen, is promising for reducing pain and the need for opioids after surgery. Studies show it can help manage pain effectively and reduce opioid use, which is important because opioids can have serious side effects and risk of addiction. ^{2 3 4 7 8}

Research Team

Eligibility Criteria

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

I am between 18 and 80 years old.

English speaking

Written and informed consent for study participation

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.

Trial Timeline

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)

Treatment Details

Interventions

• Opioid reduced regimen (Behavioural Intervention)

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.

Participant Groups

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 Canada for the following indications:

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+

Dr. Omar B. Lateef

Rush University Medical Center

Chief Executive Officer since 2022

MD from Des Moines University, Fellowship in Pulmonary and Critical Care Medicine at Rush University Medical Center

Dr. Paul E. Casey

Rush University Medical Center

Chief Medical Officer since 2021

MD, MBA

Findings from Research

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]

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 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]

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 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]

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]

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 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]

References

1. England 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. [2023]

2. United States 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. [2023]

3. United States 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. [2022]

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

Perioperative Gabapentin Use and In-Hospital Adverse Clinical Events Among Older Adults After Major Surgery. [2023]

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

Analgesic effects of gabapentin after spinal surgery. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Adverse event assessment and reporting in trials of newer treatments for post-operative pain. [2018]

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

Perioperative use of gabapentinoids for the management of postoperative acute pain: protocol of a systematic review and meta-analysis. [2023]

8. Nepal pubmed.ncbi.nlm.nih.gov

Efficacy of Preemptive Gabapentin for Lower Extremity Orthopedic surgery under Subarachnoid Block. [2022]