Acetaminophen for Post-Op Pain After Bariatric Surgery

Overseen By Mindy Rodden, PhD, RN, CPNP-AC

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Opioids

Disqualifiers: Chronic pain, Opioid use, 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 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Up to 3 months

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of different forms of acetaminophen, a common pain reliever, for managing pain after weight-loss surgeries such as gastric bypass and sleeve gastrectomy. The researchers aim to determine whether liquid or tablet forms of the medication better control pain for these patients, as their bodies may process drugs differently. Individuals who recently underwent one of these surgeries and have no issues with acetaminophen are suitable candidates for the study. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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, it focuses on acetaminophen use after surgery, so it's best to discuss your current medications with the trial coordinators.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude patients with chronic pain syndromes or opioid use, which might suggest some restrictions on pain medications.

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

Research has shown that acetaminophen is generally a safe choice for managing pain after weight-loss surgery. It effectively relieves pain and may reduce the need for stronger pain medications. Acetaminophen is a well-known and commonly used pain reliever, approved for various conditions.

This trial tests two forms of acetaminophen: a tablet and a liquid, both administered at a dose of 650 mg by mouth. Although the specific effects on individuals who have undergone weight-loss surgery are still under study, acetaminophen is usually well-tolerated. Weight-loss surgery can alter how medicines are absorbed, which is why both tablet and liquid forms are being examined.

Acetaminophen is known for having fewer side effects than many other pain relievers, especially when used as directed. However, following dosing instructions carefully is crucial to avoid potential issues like liver damage. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using acetaminophen for post-op pain after bariatric surgery because it offers a non-opioid alternative, potentially reducing the risk of opioid-related side effects and dependency. Unlike opioids, which are often used for managing post-surgical pain, acetaminophen works by inhibiting the synthesis of prostaglandins, thereby reducing pain and fever. The trial is also testing two forms of acetaminophen—tablet and liquid—providing flexibility in administration, which can be particularly beneficial for patients who have difficulty swallowing pills after bariatric surgery. This approach could enhance patient comfort and recovery while minimizing opioid exposure.

What evidence suggests that this trial's treatments could be effective for post-op pain after bariatric surgery?

Research has shown that acetaminophen is an effective option for managing pain after bariatric surgery, as it can reduce the need for stronger pain medications. In this trial, participants will receive either the tablet or liquid form of acetaminophen. For patients who have undergone gastric bypass or sleeve surgery, the liquid form might provide better pain relief, possibly due to changes in how the body absorbs medicine post-surgery. Some studies suggest that higher doses of acetaminophen may be necessary to achieve the same pain relief in individuals with obesity. Overall, acetaminophen remains a promising choice for pain relief after these surgeries. ^{1 3 4 5 6}

Who Is on the Research Team?

Daniel T Abazia, PharmD, BCPS, CPPS

Principal Investigator

Rutgers University - Ernest Mario School of Pharmacy

Are You a Good Fit for This Trial?

This trial is for adults with morbid obesity who have undergone Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy. Participants should be in need of postoperative pain management and able to take oral medication. Specific details on inclusion and exclusion criteria are not provided.

Inclusion Criteria

I am 18 or older and eligible for weight loss surgery.

Exclusion Criteria

I do not have a chronic pain condition or a history of opioid use.

Exclusion of patients from vulnerable populations as outlined by federal guidelines: children, prisoners, pregnant women, and mentally disabled persons.

I am allergic to acetaminophen or its inactive ingredients, or I cannot take pills.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive either acetaminophen tablets or liquid formulation for post-operative pain management

Up to 3 months

Daily administration during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain control and morphine equivalents

4 weeks

1-2 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Acetaminophen

Trial Overview The study aims to compare the effectiveness of liquid versus pill forms of acetaminophen for managing post-op pain in bariatric surgery patients, considering their unique drug metabolism challenges.

How Is the Trial Designed?

Group I: Oral acetaminophen - Tablet Experimental Treatment 1 Intervention

Acetaminophen 650 mg tablet by mouth

Group II: Oral acetaminophen - Liquid Experimental Treatment 1 Intervention

Acetaminophen 650 mg liquid by mouth

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?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Rutgers Robert Wood Johnson Medical School

Collaborator

Trials

7

Recruited

18,000+

Published Research Related to This Trial

A systematic review of four randomized controlled trials involving 349 patients found that intravenous (IV) acetaminophen significantly reduced postoperative pain scores and opioid use within 24 hours after bariatric surgery.

Patients receiving IV acetaminophen had a mean difference in pain scores of -0.66 and used 6.44 fewer morphine equivalent doses compared to those receiving a placebo, indicating its efficacy in pain management without affecting the length of hospital stay.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous Acetaminophen Versus Placebo in Post-bariatric Surgery Multimodal Pain Management: a Meta-analysis of Randomized Controlled Trials. Lee, Y., Yu, J., Doumouras, AG., et al.[2022]

Administering intravenous paracetamol before surgical incision in bariatric surgery patients significantly reduced postoperative pain, as indicated by lower visual analog scale (VAS) scores compared to administration at the end of the operation.

Patients who received preincisional paracetamol also required fewer opioids and tramadol for pain management post-surgery, highlighting the efficacy of early analgesia in reducing overall pain and opioid consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of timing of intravenous paracetamol on perioperative pain and cytokine levels following laparoscopic bariatric surgery, a randomized controlled trial. Semyonov, M., Bartulovic, A., Cohen, N., et al.[2022]

In a study of 180 children undergoing adenoidectomy, oral naproxen (10 mg/kg) significantly reduced the need for rescue analgesics compared to paracetamol (20 mg/kg) and placebo, indicating its efficacy in managing post-operative pain.

The addition of pethidine (1 mg/kg) further decreased the need for rescue fentanyl by 30% and halved the number of doses required, but it also doubled the incidence of post-operative nausea and vomiting (PONV), highlighting a trade-off between pain management and side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral naproxen but not oral paracetamol reduces the need for rescue analgesic after adenoidectomy in children. Korpela, R., Silvola, J., Laakso, E., et al.[2013]

Antipyretic analgesics, including aspirin, acetaminophen, and newer 2-arylpropionic acids like ibuprofen and naproxen, are widely used for treating various pain conditions, including those related to infections and minor surgeries.

While many of these medications are considered safe at low doses and available over-the-counter, their varying pharmacodynamic and pharmacokinetic properties mean that they are not equally effective for all types of pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[2-Arylpropionic acids. Role in pain therapy]. Brune, K., Hinz, B.[2006]

A study involving 251 children aged 2-12 years showed that a fixed-dose combination of paracetamol and ibuprofen for pain management after tonsillectomy was well tolerated and effective, with no significant differences in pain scores or rescue medication use between two different dosing groups.

The combination analgesic demonstrated a good safety profile, with the most common side effects being mild (nausea and vomiting), and a low incidence of postoperative bleeding at 4.4%, indicating it can be a reliable option for managing pain at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic effectiveness, pharmacokinetics, and safety of a paracetamol/ibuprofen fixed-dose combination in children undergoing adenotonsillectomy: A randomized, single-blind, parallel group trial. Playne, R., Anderson, BJ., Frampton, C., et al.[2019]

Paracetamol, first marketed in the U.K. in 1956, is widely used as an analgesic (pain reliever) and antipyretic (fever reducer).

It has gained popularity among both healthcare professionals and the public as a safer alternative to aspirin for pain and fever management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paracetamol. Meredith, TJ., Goulding, R.[2019]

In a study of 104 patients undergoing bariatric surgery, those who received intravenous acetaminophen (IV APAP) used significantly fewer opioid pain medications postoperatively, with reductions of 21 mg for laparoscopic sleeve gastrectomy (LSG) and 33 mg for laparoscopic Roux-en-Y gastric bypass (LRYGB).

Patients treated with IV APAP also experienced a shorter hospital stay and returned to normal bowel function faster, although their pain scores were similar to those who only received opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing multimodal analgesia with intravenous acetaminophen and opioids in postoperative bariatric patients. Song, K., Melroy, MJ., Whipple, OC.[2014]

In a study of 97 patients undergoing thyroid surgery, ketoprofen provided significantly better pain relief compared to propacetamol alone in the first two hours post-surgery, indicating its greater efficacy as an analgesic.

The combination of propacetamol and ketoprofen did not enhance pain relief compared to ketoprofen alone, suggesting that using both together may not be necessary for effective postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Propacetamol and ketoprofen after thyroidectomy. Fourcade, O., Sanchez, P., Kern, D., et al.[2019]

In a study of 120 patients recovering from laparoscopic cholecystectomy, the use of metamizol significantly reduced the consumption of piritramide, an opioid pain medication, compared to other treatments upon discharge from the post-anesthesia care unit.

Overall, while parecoxib showed a lower pain intensity at 24 hours post-surgery, the differences in efficacy among the non-opioid analgesics (parecoxib, metamizol, and paracetamol) were generally weak, indicating that none provided a strong advantage in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, controlled trial on non-opioid analgesics and opioid consumption for postoperative pain relief after laparoscopic cholecystectomy. Abdulla, S., Eckhardt, R., Netter, U., et al.[2022]

Acetaminophen is a well-tolerated first-line pain reliever and fever reducer in children, commonly used in pediatric care with minimal side effects.

The introduction of intravenous acetaminophen in the U.S. provides an important alternative for pediatric patients near end-of-life who may have difficulty with oral intake or rectal administration, enhancing pain management options in palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of intravenous acetaminophen (paracetamol) in a pediatric patient at the end of life: case report. Marks, AD., Keefer, P., Saul, D.[2013]

In a randomized controlled trial involving 100 patients undergoing bariatric surgery, the use of IV acetaminophen did not significantly reduce direct hospital costs or postoperative pain scores compared to a control group receiving normal saline.

However, patients in the IV acetaminophen group experienced significantly fewer emergency department visits for abdominal pain and incurred lower indirect costs, suggesting that IV acetaminophen may improve overall patient outcomes and satisfaction despite similar direct costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IV Acetaminophen Results in Lower Hospital Costs and Emergency Room Visits Following Bariatric Surgery: a Double-Blind, Prospective, Randomized Trial in a Single Accredited Bariatric Center. El Chaar, M., Stoltzfus, J., Claros, L., et al.[2018]

Intravenous paracetamol (1 g) has been shown to provide significantly better pain relief than placebo in adults after surgeries, and it also reduces the need for opioid pain relief, making it an effective first-line treatment.

In pediatric patients, intravenous paracetamol (15 mg/kg) demonstrated similar pain relief and fever reduction compared to propacetamol (30 mg/kg), with a good safety profile and very rare adverse reactions (<1/10,000).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous paracetamol (acetaminophen). Duggan, ST., Scott, LJ.[2022]

Paracetamol is a widely used and effective analgesic and antipyretic, with a strong safety profile when used as directed, making it the preferred choice for treating mild to moderate pain in various populations, including children and pregnant women.

Despite concerns about liver toxicity in cases of overdose, early treatment with N-acetylcysteine can prevent serious damage, and ongoing research suggests potential new therapeutic applications for paracetamol beyond pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paracetamol: past, present, and future. Prescott, LF.[2022]

In a study of 183 patients undergoing laparoscopic Roux-en-Y gastric bypass, the use of scheduled intravenous acetaminophen reduced the demand for narcotic analgesics by 25% and the total dosage required by 20% in the first 24 hours post-surgery.

These findings support the routine use of multimodal analgesia, including intravenous acetaminophen, to minimize narcotic use and its associated side effects in bariatric surgery patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scheduled intravenous acetaminophen reduces postoperative narcotic analgesic demand and requirement after laparoscopic Roux-en-Y gastric bypass. Saurabh, S., Smith, JK., Pedersen, M., et al.[2015]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06658574

Oral Acetaminophen for Post-Op Pain Management in ... This evidence leads to the hypothesis that higher dosing of oral acetaminophen is required to achieve adequate pain control when compared to non-obese patients.

2. trialx.com trialx.com/clinical-trials/listings/310657/oral-acetaminophen-for-post-op-pain-management-in-bariatric-surgery-patients/

Oral Acetaminophen for Post-Op Pain Management in ... H1: The investigators hypothesize that based on post-operative changes, the liquid formulation of acetaminophen will result in improved pain control among ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9019635/

The Effect of Scheduled Intravenous Acetaminophen in an ... In this study, we found that IV acetaminophen, within the context of an ERP abdominal surgery population, was not very effective at reducing postoperative pain ...

4. jpsmjournal.com jpsmjournal.com/article/S0885-3924(24)00044-7/fulltext

Management of Pain Medication in Patients With a History ... Management of Pain Medication in Patients With a History of Bariatric Surgery: A Systematic Review - Journal of Pain and Symptom Management.

5. withpower.com withpower.com/trial/phase-2-bariatric-surgery-gastric-bypass-10-2024-bead0

Acetaminophen for Post-Op Pain After Bariatric Surgery Yes, acetaminophen is a promising option for pain relief after bariatric surgery. Studies show it can help manage pain effectively, reduce the need for stronger ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4671470/

Effect of Intravenous Acetaminophen on Postoperative ... Our retrospective chart-review analysis indicates that IV acetaminophen is ineffective in reducing opioid consumption in bariatric surgery patients.