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

60 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Multimodal Analgesia for post-surgery pain in bariatric patients?

Research shows that multimodal analgesia, which uses a combination of different pain relief methods, can reduce the need for narcotic painkillers and their side effects in bariatric surgery patients. This approach can lead to better pain control, faster recovery, and improved patient satisfaction. ^{1 2 3 4 5}

Is multimodal pain management safe for humans?

Multimodal pain management, which uses a combination of different pain relief methods, is generally considered safe and can reduce the need for narcotics, which often have unwanted side effects. Studies suggest it may lead to fewer complications and better overall health outcomes after surgery. ^{1 2 3 6 7}

How is multimodal analgesia treatment different for post-surgery pain in bariatric patients?

Multimodal analgesia is unique because it combines different types of pain relief methods to reduce the need for narcotics, which can have side effects. This approach is particularly beneficial for bariatric patients as it helps manage pain effectively while minimizing the risk of complications associated with narcotic use. ^{1 2 5 8 9}

What is the purpose of this trial?

Patients undergoing Bariatric Surgery at the University of California Davis Medical Center will be divided into two groups, one receiving Standard of Care pain control medications vs the second group which will receive non-narcotic pain medications with rescue pain medications available if needed

Research Team

Barbara Jachniewicz, MSN, CRNFA,

Principal Investigator

Nurse Practitioner, Department of Surgery

Mohamed R Ali, MD, FACS

Principal Investigator

Professor of Surgery

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

References

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

Multimodal analgesia reduces narcotic requirements and antiemetic rescue medication in laparoscopic Roux-en-Y gastric bypass surgery. [2013]

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

Perioperative Analgesia for Fast-Track Laparoscopic Bariatric Surgery. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Perioperative intravenous acetaminophen and NSAIDs. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Pilot study of a novel pain management strategy: evaluating the impact on patient outcomes. [2022]

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

Combined preemptive and preventive analgesia in morbidly obese patients undergoing open gastric bypass: A pilot study. [2013]

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

Nonopioid Adjuncts and Alternatives. [2021]

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

Synergism between analgesics. [2019]

8. Brazil pubmed.ncbi.nlm.nih.gov

Comparison of three intraoperative analgesic strategies in laparoscopic bariatric surgery: a retrospective study of immediate postoperative outcomes. [2022]

9. United States 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. [2022]