Non-Narcotic Pain Medication for Post-Surgery Pain in Bariatric Patients

Overseen By William Smith, BS, CCRP

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of California, Davis

Must not be taking: Oral pain medications

Disqualifiers: Men, Arthritis, Fibromyalgia, 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: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to managing pain after weight loss surgery. Some patients will receive the usual pain medications, including strong drugs like morphine, while others will try a mix of non-narcotic options such as Tylenol and Gabapentin, a medication for nerve pain. This combination of non-narcotic options is known as Multimodal Analgesia. The goal is to determine if the non-narcotic methods can control pain as effectively without the side effects of stronger drugs. Women with a BMI over 30 undergoing weight loss surgery at UC Davis may be suitable candidates if they have never had major abdominal surgery before. As a Phase 4 trial, this study involves treatments that are already FDA-approved and proven effective, aiming to understand how they can benefit more patients.

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 excludes people who need daily oral pain medications. This might mean you should not be on regular pain meds to participate.

What is the safety track record for these treatments?

Research shows that the pain treatment under study, called multimodal analgesia, is usually easy for people to handle. This method can manage post-surgical pain while reducing opioid use. Patients often receive a mix of medications like Gabapentin and Tylenol to control pain. These drugs are generally safe and have been widely used for pain relief.

Gabapentin plays a key role in this treatment and often manages nerve pain. Most people tolerate it well, though some might experience mild side effects like dizziness or tiredness. Serious side effects are rare. Tylenol (also known as acetaminophen) is another common pain reliever and is safe when used as directed.

Overall, studies on various surgeries have shown that using these medications together in multimodal analgesia reduces the need for stronger painkillers and manages pain effectively. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the new non-narcotic pain management approach for post-surgery pain in bariatric patients because it offers a way to manage pain without relying on opioids like Dilaudid or Morphine. This treatment uses a combination of Gabapentin and Tylenol (Ofirmev) administered through IV and oral forms, which can reduce the risk of opioid-related side effects and dependency. Gabapentin, taken before and after surgery, helps in modulating nerve signals, while Tylenol aids in reducing fever and alleviating pain. By providing effective pain relief without narcotics, this approach could lead to faster recovery times and improved patient safety.

What evidence suggests that Multimodal Analgesia might be an effective treatment for post-surgery pain in bariatric patients?

Research has shown that using a combination of different pain relief methods, known as multimodal analgesia, effectively manages post-surgery pain. In this trial, some participants will receive this multimodal approach, which includes medications like Gabapentin and Tylenol to manage pain without relying on narcotics. Studies have found that this approach works better than the usual method of using only opioids, often given for surgeries like weight loss surgery. Specifically, patients have reported feeling less pain and needing fewer opioids, which can be addictive. This method reduces the use of opioids and their possible side effects. Overall, multimodal analgesia provides a safer way to handle pain after surgery. ^{4 6 7 8 9}

Who Is on the Research Team?

Barbara Jachniewicz, MSN, CRNFA,

Principal Investigator

Nurse Practitioner, Department of Surgery

Mohamed R Ali, MD, FACS

Principal Investigator

Professor of Surgery

Are You a Good Fit for This Trial?

This trial is for women aged 35-65 with obesity (BMI >=30) who are undergoing bariatric surgery at UC Davis Medical Center and have an ASA score of ≤3. Candidates must not have had previous abdominal surgeries, be planning additional procedures, or suffer from chronic pain conditions like arthritis or fibromyalgia.

Inclusion Criteria

My health is stable enough for surgery according to the ASA score.

My BMI is 30 or higher.

I am between 35 and 65 years old.

Exclusion Criteria

My health is severely limited by my illness.

I do not qualify for weight loss surgery according to NIH standards.

I am a man.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Patients receive Gabapentin pre-operatively on-call 120 minutes prior to surgery starting

1 day

Post-operative Treatment

Post surgery, patients receive pain control medications: standard care group with PCA and narcotics, experimental group with Gabapentin and Tylenol

14 days

Daily monitoring for 3 days, periodic contact up to 14 days

Follow-up

Participants are monitored for pain control and usage of rescue medications

14 days

What Are the Treatments Tested in This Trial?

Interventions

• Multimodal Analgesia

Trial Overview The study compares standard pain control medications to a regimen of non-narcotic drugs in post-bariatric surgery patients. One group will receive typical analgesics while the other will get alternative options with rescue meds available if necessary.

How Is the Trial Designed?

Group I: Multi-Modal Experimental Treatment 10 Interventions

Patients will receive Gabapentin pre-operatively on-call 120 minutes prior to surgery starting. Patients at the conclusion of surgery will have additional doses of Ofirmev (IV Tylenol) and Gabapentin via IV based on patients pre-operative weight. Post surgery the patient will be transitioned to oral pain medications (Tylenol and Gabapentin) with rescue medications available for breakthrough pain control.

Group II: Standard of Care Active Control 8 Interventions

The group will receive the standard of care pain control protocol after index Bariatric Surgery which includes the use of a PCA (patient controlled analgesia) with Dilaudid or Morphine Sulphate, transitioning to oral narcotic based pain control medications.

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

Approved in United States as Multimodal Analgesia for:

• Postoperative pain management
• Acute pain management

Approved in European Union as Multimodal Analgesia for:

• Perioperative pain management
• Chronic pain management

Approved in Canada as Multimodal Analgesia for:

• Postoperative pain management
• Trauma pain management

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Published Research Related to This Trial

In a study of 271 patients undergoing laparoscopic bariatric surgery, the multimodal analgesia (MMA) approach combined with methadone resulted in significantly lower rates of moderate to severe postoperative pain compared to traditional opioid-based techniques.

However, this MMA approach was also associated with a higher incidence of intraoperative hypotension, indicating a potential safety concern that needs to be monitored during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of three intraoperative analgesic strategies in laparoscopic bariatric surgery: a retrospective study of immediate postoperative outcomes. Silva, LMD., Ho, AMH., Oliveira, DR., et al.[2022]

Intravenous acetaminophen (APAP) is a safe and effective option for managing mild-to-moderate postoperative pain, with a favorable side effect profile and no significant drug-drug interactions.

Using intravenous APAP can help reduce opioid consumption and its associated adverse effects, making it a preferred choice in situations where surgical bleeding is a concern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative intravenous acetaminophen and NSAIDs. Smith, HS.[2022]

Multimodal analgesia, which involves using a combination of different pain relief medications, has been shown to improve pain management after surgery, particularly for pain associated with movement.

Despite the promising results, more research is needed to determine the best combinations of analgesics for specific surgical procedures and to evaluate potential side effects in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synergism between analgesics. Kehlet, H.[2019]

The novel multimodal pain management strategy significantly reduced intraoperative opioid requirements, with experimental patients receiving an average of 158 mcg of fentanyl compared to 299 mcg in the control group (p < 0.01).

Patients in the experimental group experienced lower postoperative pain scores and shorter hospital stays (3.0 days vs. 4.1 days, p = 0.04), indicating improved recovery outcomes without increasing complication rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of a novel pain management strategy: evaluating the impact on patient outcomes. Keller, DS., Tahilramani, RN., Flores-Gonzalez, JR., et al.[2022]

In a study of 181 patients undergoing laparoscopic Roux-en-Y gastric bypass surgery, a multimodal analgesia approach using intravenous acetaminophen and ketorolac significantly reduced postoperative narcotic consumption by 73.8% compared to traditional hydromorphone patient-controlled analgesia.

Patients receiving the multimodal treatment also experienced fewer instances of needing antiemetic rescue medication, with only 20.2% requiring it compared to 34.8% in the hydromorphone group, indicating a potential reduction in opioid-related side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal analgesia reduces narcotic requirements and antiemetic rescue medication in laparoscopic Roux-en-Y gastric bypass surgery. Ziemann-Gimmel, P., Hensel, P., Koppman, J., et al.[2013]

Multimodality nonopioid analgesia has been shown to be effective for managing pain, suggesting it can be a valuable alternative to opioids.

The decision to use opioids or nonopioids for pain control should be guided by a careful assessment of the risks and benefits associated with each treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonopioid Adjuncts and Alternatives. Husain, Q., Banks, C., Gray, ST.[2021]

In a study of 20 severely obese patients undergoing open gastric bypass, those who received combined preemptive and preventive analgesia reported significantly less pain and used 40% less narcotic medication during their hospital stay compared to those receiving placebo.

The benefits of this analgesic approach were evident even after the local anesthetic effects wore off, suggesting it may be an effective strategy for managing pain while minimizing the risks of sedation and respiratory depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined preemptive and preventive analgesia in morbidly obese patients undergoing open gastric bypass: A pilot study. Kamelgard, JI., Kim, KA., Atlas, G.[2013]

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 412 bariatric surgery patients, multimodal intraoperative analgesia significantly improved postoperative outcomes, including better pain control, shorter recovery times, and reduced opioid use compared to traditional morphine-based analgesia.

The combination of tramadol, acetaminophen, and diclofenac was particularly effective, leading to fewer complications and facilitating faster recovery, making it a safe and efficacious option for managing pain in bariatric surgery patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative Analgesia for Fast-Track Laparoscopic Bariatric Surgery. Bamgbade, OA., Oluwole, O., Khaw, RR.[2018]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0007091224004756

Efficacy of nonopioid analgesics and adjuvants in ... Multimodal anaesthesia improves pain relief in patients with obesity, but its effect on reducing opioid use, which is associated with significant adverse ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28120147/

Perioperative Analgesia for Fast-Track Laparoscopic ... Conclusions: Multimodal intraoperative analgesia provides better postoperative analgesia, less complications and better perioperative outcomes and facilitates ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12156663/

Evaluating the Role of Multimodal Analgesia - PubMed Central The study demonstrated that MMA significantly improved postoperative pain management compared to standard opioid-based care. Pain scores, measured using the VAS ...

4. rapm.bmj.com rapm.bmj.com/content/early/2025/07/17/rapm-2025-106720

Optimal multimodal analgesia combinations to reduce pain ... Conclusion Our findings further support existing evidence on the effectiveness of MMA in reducing postoperative pain and opioid use following ...

5. healthcatalyst.com healthcatalyst.com/learn/success-stories/multimodal-pain-management-mission-health

Multimodal Pain Management Approach Reduces Opioid ... Mission Health sought a comprehensive, data-driven, evidence-based approach to reduce opioid prescribing after bariatric surgery, decreasing the risk for misuse ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7999688/

Efficacy of Multimodal Analgesia for Postoperative Pain ... In conclusion, our data suggest MMA is an effective method of pain control and opioid reduction in patients undergoing surgery for head and neck ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04240626

Multimodal Analgesia Effect on Post Surgical Patient Post surgery the patient will be transitioned to oral pain medications (Tylenol and Gabapentin) with rescue medications available for breakthrough pain control.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6515722/

Multimodal analgesia as an essential part of enhanced ... Several studies have estimated moderate-to-severe pain scores as high as 30% in the 24 hours after surgery.[7,8] The solution to this is proper preoperative ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2405603022000085

Perioperative management of acute pain by multimodal ... This is a prospective cohort study designed to evaluate a multimodal protocol of postoperative analgesia in subjects with morbid obesity undergoing LSG.