Pain Management Strategies for Postoperative Pain

Overseen By Anna Valencia

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Arizona

Must not be taking: Narcotics, Insulin, Steroids, others

Disqualifiers: Chronic pain, Kidney disease, 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: 3

244 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. However, if you are on chronic pain management with narcotics, you cannot participate in the trial.

What data supports the effectiveness of the treatment TAP Block with Liposomal Bupivacaine for managing postoperative pain?

Research shows that non-narcotic pain regimens can effectively control postoperative pain and reduce the need for narcotics, as seen in studies comparing non-opioid and opioid pain control strategies. Additionally, multimodal pain management strategies have been shown to decrease narcotic use and improve patient outcomes. ^{1 2 3 4 5}

Is the pain management treatment generally safe for humans?

Non-narcotic pain management options, like those using nonsteroidal anti-inflammatory drugs, are being researched for their safety, as they avoid narcotic side effects like breathing problems and nausea, but they may have risks like bleeding and kidney issues. Opioid painkillers, while effective, can lead to adverse events, especially in patients who haven't used them before. ^{1 3 6 7 8}

How does the Narcotic Regimen, Non-Narcotic Regimen treatment for postoperative pain differ from other treatments?

This treatment is unique because it combines narcotic and non-narcotic medications to manage postoperative pain, aiming to reduce the side effects associated with narcotics like respiratory issues and nausea, while still providing effective pain relief. ^{2 3 6 9 10}

What is the purpose of this trial?

This study aims to better understand the role that narcotic vs. non-narcotic multimodal pain management play in patients' pain following bariatric surgery (Laproscopic Surgery and Robotic Assisted Surgery). Participation in this study will last approximately 90 days following surgery. During that 90 day period, participants will be asked to report pain and nausea every 4 hours to a study coordinator or nurse while they are recovering in the hospital. Following discharge from the hospital patients will be asked to report pain, nausea, and any medical changes 7 days, 30 days, and 90 days from surgical date. The procedures and medications used in this study are FDA approved medical therapies and are part of Standard of Care for this population. This study aims to therapeutically investigate efficacy of the proposed pain management regimens. The procedures and individual medications are not the subject of research as they are considered routine well established and documented interventions for obesity and the treatment of post operative pain.

Eligibility Criteria

This trial is for adults over 18 who are scheduled for elective Laparoscopic or Robotic Sleeve Gastrectomy bariatric surgery with a BMI over 35. It's not for those pregnant, on chronic pain narcotics, having re-operative bariatric surgery, unable to walk, with significant liver disease, insulin-treated diabetes, advanced kidney disease, pulmonary hypertension or heart failure.

Inclusion Criteria

Patient of Principal Investigator or Co-Investigator

I am scheduled for weight loss surgery at the BUMCP Bariatric Clinic.

My BMI is over 35.

Exclusion Criteria

I am planning to have or have had a second bariatric surgery.

I am on pain medication since my first visit or before surgery.

I have been diagnosed with Congestive Heart Failure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Recovery

Participants undergo bariatric surgery and initial recovery with pain management protocols

1 week

In-hospital stay

Post-operative Monitoring

Participants report pain and nausea every 4 hours while in the hospital and at 7, 30, and 90 days post-surgery

90 days

3 follow-up visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Narcotic Regimen
• Non-Narcotic Regimen
• TAP Block

Trial Overview The study compares four pain management strategies after bariatric surgery: narcotic and non-narcotic regimens both with and without TAP block (a local anesthesia technique). Participants will report their pain and nausea levels regularly during a 90-day post-surgery period.

Participant Groups

Group I: narcotic regimen with TAP block Active Control 1 Intervention

Patient will receive Tap Block and will be administered the Narcotic Pain Regimen post-operatively

Group II: non-narcotic regimen with no TAP block Active Control 1 Intervention

Patient will not receive TAP block and will be administered Non-narcotic Pain Regimen post-operatively

Group III: non-narcotic regimen with TAP block Active Control 1 Intervention

Patient will receive Tap Block and will be administered Non-narcotic Pain Regimen post-operatively

Group IV: narcotic regimen with no TAP block Active Control 1 Intervention

Patient will not receive TAP block and will be administered the Narcotic Pain Regimen post-operatively

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Findings from Research

In a study of 182 patients undergoing inguinal hernia surgery, intravenous parecoxib resulted in higher patient satisfaction (87%) compared to intravenous propacetamol (70%) for postoperative pain management.

Although parecoxib had a higher average cost per patient (€6.65 vs €5.28 for propacetamol), the incremental cost per additional patient satisfied was only slightly higher (€8.02), suggesting that parecoxib may provide better value in terms of patient satisfaction despite its higher cost.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost analysis applied to postoperative analgesia regimens: a comparison between parecoxib and propacetamol. Tilleul, P., Weickmans, H., Sean, PT., et al.[2018]

A study involving 61 patients who underwent meniscectomy or meniscal repair found that a multimodal nonopioid pain regimen provided equivalent pain control compared to a traditional opioid regimen, with no significant differences in pain levels during the first 10 days post-surgery.

Both pain management strategies resulted in similar patient-reported outcomes and side effects, indicating that nonopioid protocols can be a safe and effective alternative to opioids for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal Nonopioid Pain Protocol Provides Equivalent Pain Versus Opioid Control Following Meniscus Surgery: A Prospective Randomized Controlled Trial. Jildeh, TR., Okoroha, KR., Kuhlmann, N., et al.[2021]

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 13,389 opioid-free patients who underwent surgery, 9.1% experienced opioid-related adverse drug events (ORADEs) after receiving postoperative opioids, highlighting a significant risk in this population.

Patients with ORADEs faced severe consequences, including 32% higher hospitalization costs, 45% longer hospital stays, and 2.2 times the odds of mortality, emphasizing the need for careful management of opioid use post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Burden of Opioid-Related Adverse Drug Events on Hospitalized Previously Opioid-Free Surgical Patients. Urman, RD., Seger, DL., Fiskio, JM., et al.[2023]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Simple frameshifts in minimally invasive surgery postoperative pain management significantly reduce opiate prescriptions. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Cost analysis applied to postoperative analgesia regimens: a comparison between parecoxib and propacetamol. [2018]

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

Decreasing postoperative narcotics in reconstructive pelvic surgery: a randomized controlled trial. [2018]

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

Multimodal Nonopioid Pain Protocol Provides Equivalent Pain Versus Opioid Control Following Meniscus Surgery: A Prospective Randomized Controlled Trial. [2021]

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

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

6. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of Analgesic Effects of Ketorolac Plus Apotel to Meperidine in Patients Undergoing Right Thoracotomy: A Double-Blind Randomized Clinical Trial. [2023]

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

Narcotic-Free, Over-the-Counter Pain Management After Wide-Awake Hand Surgery. [2022]

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

The Burden of Opioid-Related Adverse Drug Events on Hospitalized Previously Opioid-Free Surgical Patients. [2023]

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

Pain Management in Plastic Surgery. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Regional analgesia in neonates undergoing thoracoabdominal surgeries: A pilot study. [2019]