Opioid-Free Pain Management for Postoperative Pain

Age: Any Age

Sex: Female

Trial Phase: Phase 4

Sponsor: Northwell Health

Must not be taking: Illicit substances, Gabapentin

Disqualifiers: Pregnancy, Renal disease, Seizure disorder, 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

Compensation: Varies

Number of Visits: 1

70 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a double-arm randomized control trial evaluating the impact of preoperative opioid-free analgesia on time to trial of void in ambulatory urogynecologic surgeries. The investigators hypothesize that receipt of acetaminophen, celecoxib and gabapentin preoperatively versus acetaminophen alone will reduce the time to trial of void in patients undergoing same-day minor urogynecologic procedures.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are currently using gabapentin at home, you cannot participate in the trial.

What data supports the effectiveness of the drug acetaminophen for opioid-free postoperative pain management?

Research shows that acetaminophen (also known as paracetamol) is effective for treating postsurgical pain and can reduce the need for opioids, which helps minimize opioid-related side effects. It is commonly used in pediatric postoperative pain management and has been shown to be safe and effective in various acute pain models. ^{1 2 3 4 5}

Is opioid-free pain management using acetaminophen safe for postoperative pain?

Acetaminophen (also known as paracetamol) is generally considered safe for managing mild-to-moderate pain, including postoperative pain, when used at recommended doses. However, it may not provide sufficient pain relief on its own for some patients, and combining it with other medications like weak opioids can be a safer alternative to anti-inflammatory drugs, which have potential gastrointestinal and cardiovascular risks. ^{1 6 7 8 9}

What makes the drug combination of Acetaminophen, Celecoxib, and Gabapentin unique for managing postoperative pain?

This drug combination is unique because it aims to manage postoperative pain without using opioids, which are commonly associated with risks of addiction and side effects. Acetaminophen and Celecoxib help reduce inflammation and pain, while Gabapentin is used for nerve-related pain, providing a comprehensive approach to pain management. ^{1 5 10 11 12}

Eligibility Criteria

This trial is for patients scheduled for same-day minor urogynecologic surgeries who can take medications like acetaminophen, celecoxib, and gabapentin. Specific eligibility criteria are not provided.

Inclusion Criteria

In good general health as evidenced by medical history

I am willing and able to follow the study rules and attend all appointments.

Provision of signed and dated informed consent form

Exclusion Criteria

I do not speak English or Spanish.

I am under 18 years old.

I have a serious heart condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative Treatment

Participants receive preoperative opioid-free analgesia with acetaminophen, celecoxib, and gabapentin or acetaminophen alone

Single day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for time to trial of void after surgery

1-2 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Acetaminophen
• Celecoxib
• Gabapentin

Trial Overview The study tests if taking a combination of acetaminophen, celecoxib, and gabapentin before surgery helps patients recover bladder function faster than just acetaminophen alone. It's a randomized control trial with two groups.

Participant Groups

Group I: Standard of Care (SOC) (acetaminophen) and investigational product (celecoxib + gabapentin) Experimental Treatment 3 Interventions

one time dose of 1000mg acetaminophen orally combined with 400mg celecoxib orally, and 300mg gabapentin orally

Group II: Standard of Care (SOC) (acetaminophen) Active Control 1 Intervention

one time dose of 1000mg acetaminophen orally

Acetaminophen is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Tylenol for:

• Pain relief
• Fever reduction

Approved in European Union as Paracetamol for:

• Pain relief
• Fever reduction

Approved in Canada as Tylenol for:

• Pain relief
• Fever reduction

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Findings from Research

In a study of 120 children undergoing adenoidectomy or tonsillotomy, the combination of intravenous ketoprofen and paracetamol significantly reduced the need for rescue analgesia compared to either drug alone, with only 17.5% of the combination group requiring additional pain relief.

Children receiving only paracetamol experienced the highest pain scores and the earliest need for rescue analgesia, indicating that the combination therapy is more effective for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Tonsillotomy and adenotonsillectomy in childhood. Study on postoperative pain therapy]. Platzer, M., Likar, R., Stettner, H., et al.[2021]

In a study of 120 children undergoing tonsillectomy, intravenous paracetamol and dipyrone provided effective pain relief compared to a placebo, with significant reductions in pain scores at specific time points post-surgery.

Both paracetamol and dipyrone resulted in lower requirements for rescue analgesia (pethidine) compared to placebo, indicating their efficacy in managing postoperative pain without significant adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Administration of paracetamol versus dipyrone by intravenous patient-controlled analgesia for postoperative pain relief in children after tonsillectomy]. Sener, M., Kocum, A., Caliskan, E., et al.[2015]

In a study of 120 children undergoing tonsillectomy, both intravenous paracetamol and dipyrone provided effective pain relief compared to a placebo, particularly noted at 6 hours post-surgery.

Both medications significantly reduced the need for additional pain relief (pethidine) compared to the placebo group, indicating their efficacy in managing postoperative pain without significant adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Administration of paracetamol versus dipyrone by intravenous patient-controlled analgesia for postoperative pain relief in children after tonsillectomy. Sener, M., Kocum, A., Caliskan, E., et al.[2017]

Multimechanistic approaches to postoperative pain relief, including the use of acetaminophen, can improve pain management, reduce the need for opioids, and lower the risk of opioid-related side effects, enhancing overall surgical outcomes.

Oral acetaminophen, especially when combined with opioids, has been shown to be safe and effective for managing postsurgical pain, and transitioning from intravenous to oral formulations is a reasonable strategy for continued pain control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous multimechanistic postoperative analgesia: a rationale for transitioning from intravenous acetaminophen and opioids to oral formulations. Pergolizzi, JV., Raffa, RB., Tallarida, R., et al.[2013]

A survey of 1,500 anesthesia departments in Germany revealed that rectally administered acetaminophen is the standard for postoperative pain management in pediatric patients, with an increased use of opioids compared to past practices.

Despite the availability of various pain management options, 71.1% of anesthesiologists believe that postoperative pain management for children still requires improvement, indicating a need for better strategies and techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Postoperative pain therapy in pediatrics. Results of a representative survey in Germany]. Bremerich, DH., Neidhart, G., Roth, B., et al.[2019]

NSAIDs are generally more effective than paracetamol for pain relief in dental surgery, while their effectiveness is similar in major and orthopedic surgeries, indicating that the choice of pain management may depend on the type of surgery.

Paracetamol is a safer alternative to NSAIDs due to its lower incidence of adverse effects, making it a preferred option for high-risk patients; combining paracetamol with NSAIDs may enhance pain relief, but more research is needed to assess potential side effects from this combination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effect of paracetamol, NSAIDs or their combination in postoperative pain management: a qualitative review. Hyllested, M., Jones, S., Pedersen, JL., et al.[2022]

Chronic pain affects up to 50% of the European population, leading to a growing need for safe and effective pain management strategies, especially among the elderly with complex health issues.

While traditional pain relievers like NSAIDs and paracetamol are effective, they carry risks such as gastrointestinal issues and cardiovascular events, prompting a shift towards safer alternatives like fixed-dose combinations of paracetamol with weak opioids, such as tramadol, for managing moderate-to-severe pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain management today - what have we learned? Langford, RM.[2022]

In a study of 56 pediatric patients undergoing ambulatory surgery, the combination of acetaminophen and B vitamins resulted in significantly better pain management, with 58% of patients reporting a pain score of less than 2 immediately after surgery.

Patients receiving the acetaminophen + B vitamins combination also had a higher rate of discharge with a pain score of less than 1 (89%), indicating that this combination is both effective and safe for postoperative analgesia in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective analgesic between acetominophen + B vitamins vs. acetominophen in pediatric ambulatory surgery. Galván-Montaño, A., Reyes-García, G., Suárez-Roa, Mde L., et al.[2018]

In a study of 40 children aged 5-15 undergoing tonsillectomy, scheduled doses of acetaminophen (60 mg/kg orally or 90 mg/kg rectally) were found to be insufficient for managing postoperative pain, with many children reporting severe pain post-surgery.

The findings suggest that current recommended doses of acetaminophen may not provide adequate pain relief for children after tonsillectomy, indicating a need for further research into higher doses or alternative analgesics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examination of acetaminophen for outpatient management of postoperative pain in children. Rømsing, J., Hertel, S., Harder, A., et al.[2019]

In a study of 76 pediatric patients undergoing adenotonsillectomy, paracetamol alone was found to be effective and safe for managing postoperative pain, with an average pain intensity of 3.36 on a scale and a duration of pain lasting about 3 days.

Postoperative pain was notably more intense in patients who had surgery due to infectious conditions, but overall, the procedure had a low complication rate, with only 3.9% experiencing self-limited bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Efficacy of Paracetamol in the Control of Pain After Adenotonsillectomy in the Pediatric Population. Costa, R., Fernandes, Â., Fonseca, R.[2022]

In a study of 43 children undergoing bilateral myringotomy and tube placement, preoperative administration of either acetaminophen or ibuprofen did not significantly reduce postoperative pain compared to a placebo.

The Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) scores showed no differences among the groups at various time points, indicating that neither analgesic provided effective pain relief in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative analgesia with preoperative oral ibuprofen or acetaminophen in children undergoing myringotomy. Bennie, RE., Boehringer, LA., McMahon, S., et al.[2019]

Effective pain management after surgery involves pre-discharge discussions about expected pain and a clear management plan, with paracetamol and non-steroidal anti-inflammatory drugs being suitable for most patients.

While short-acting opioids can be used for a limited time post-surgery, they must be carefully monitored due to the risk of adverse effects and misuse, and gabapentinoids are primarily effective for neuropathic pain rather than nociceptive pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of postsurgical pain in the community. MacPherson, R., Pattullo, G.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Tonsillotomy and adenotonsillectomy in childhood. Study on postoperative pain therapy]. [2021]

2. Brazil pubmed.ncbi.nlm.nih.gov

[Administration of paracetamol versus dipyrone by intravenous patient-controlled analgesia for postoperative pain relief in children after tonsillectomy]. [2015]

3. Brazil pubmed.ncbi.nlm.nih.gov

Administration of paracetamol versus dipyrone by intravenous patient-controlled analgesia for postoperative pain relief in children after tonsillectomy. [2017]

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

Continuous multimechanistic postoperative analgesia: a rationale for transitioning from intravenous acetaminophen and opioids to oral formulations. [2013]

5. Germany pubmed.ncbi.nlm.nih.gov

[Postoperative pain therapy in pediatrics. Results of a representative survey in Germany]. [2019]

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

Comparative effect of paracetamol, NSAIDs or their combination in postoperative pain management: a qualitative review. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Pain management today - what have we learned? [2022]

8. Mexico pubmed.ncbi.nlm.nih.gov

Effective analgesic between acetominophen + B vitamins vs. acetominophen in pediatric ambulatory surgery. [2018]

9. France pubmed.ncbi.nlm.nih.gov

Examination of acetaminophen for outpatient management of postoperative pain in children. [2019]

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

Evaluation of the Efficacy of Paracetamol in the Control of Pain After Adenotonsillectomy in the Pediatric Population. [2022]

11. France pubmed.ncbi.nlm.nih.gov

Postoperative analgesia with preoperative oral ibuprofen or acetaminophen in children undergoing myringotomy. [2019]

12. Australia pubmed.ncbi.nlm.nih.gov

Management of postsurgical pain in the community. [2021]