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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores different pain management strategies for individuals undergoing bariatric surgery, a procedure that aids in weight loss. It examines both narcotic (opioid-based) and non-narcotic (non-opioid) pain relief options, as well as a TAP block (Transversus Abdominis Plane Block, a type of local anesthesia). Participants will report their pain and nausea during their hospital stay and at intervals over 90 days post-surgery. Ideal participants are those planning elective laparoscopic or robotic sleeve gastrectomy surgery with a BMI over 35. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand its benefits for a broader patient population.

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 is the safety track record for these treatments?

Research has shown that the treatments tested in this study are generally safe for patients. For the narcotic treatment plan, studies have found that a mix of different pain relief methods can effectively manage pain and reduce risks associated with opioids, such as addiction or side effects. These opioid-based treatments are commonly used and recommended for managing post-surgery pain.

For the non-narcotic treatment plan, research suggests that non-opioid painkillers can also effectively reduce pain after surgery. Although they might not be as strong as narcotics, they tend to have fewer side effects and a lower risk of addiction. However, some non-narcotic options, like pregabalin, can cause serious side effects, so careful use is important.

The TAP block, a type of anesthesia that numbs the belly area, is generally considered safe and effective for immediate pain relief after surgery. It is often used to enhance patient comfort post-operation.

All these treatments are part of standard care and are well-documented for managing post-surgery pain. Participants in the trial might experience some common side effects, but these treatments are widely used and understood. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for postoperative pain management because they explore the effectiveness of incorporating a TAP block, a type of regional anesthesia, alongside both narcotic and non-narcotic pain regimens. Unlike standard care options that often rely heavily on narcotics, these treatment combinations aim to reduce narcotic use by potentially enhancing pain control with the TAP block. The non-narcotic regimen with TAP block is particularly promising as it could offer effective pain relief without the side effects associated with opioids. By experimenting with these combinations, researchers hope to find a more balanced approach to managing pain after surgery, potentially improving patient recovery and reducing reliance on narcotics.

What evidence suggests that this trial's treatments could be effective for postoperative pain management?

Research shows that narcotic medications often manage post-surgery pain, with about 89.6% of patients using them. In this trial, one group will receive a narcotic regimen with a TAP block, a type of anesthesia that numbs the abdominal area, while another group will receive the narcotic regimen without the TAP block. Studies also indicate that non-narcotic treatments can manage pain effectively, with only 10.4% of patients experiencing moderate to severe pain after surgery. In this trial, some participants will receive a non-narcotic regimen with a TAP block, and others will receive the non-narcotic regimen without the TAP block. Additionally, using a TAP block with liposomal bupivacaine can significantly reduce the need for extra pain medication. Both narcotic and non-narcotic methods effectively manage pain, and a TAP block can enhance their effectiveness. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11973795/

Comparing Analgesic Regimen Effectiveness and Safety ... The primary effectiveness outcome is patient-reported worst daily pain intensity over the first 7 days after surgery. The primary safety outcome ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2957391225000361

Clinical practice guidelines for postoperative pain ... The control group used postoperative intravenous opioids. Pooled results showed that, compared with controls, opioid‑sparing regimens reduced resting VAS ...

3. link.springer.com link.springer.com/article/10.1007/s40122-025-00762-2

The Impact of Opioid-Sparing Analgesia on Postoperative ... Opioids play an essential role in pain management; recent studies indicate that 89.6% of patients receive opioid treatment postoperatively [3].

4. clinicalpainadvisor.com clinicalpainadvisor.com/news/opioid-sparing-analgesia-postoperative-pain/

Opioid-Sparing Analgesia Linked to Reduced ... The primary outcome was total morphine consumption within 24 hours after surgery, measured in intravenous morphine milligram equivalents (IMME).

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7543219/

Postoperative Pain Management of Non–“Opioid-Naive” ... Furthermore, 41.4% of opioid users sought more pills after surgery compared with 14.0% among nonopioid users. The pain control program was more effective in ...

6. link.springer.com link.springer.com/article/10.1007/s44254-023-00043-1

Perioperative multimodal analgesia: a review of efficacy ... Multimodal analgesic strategies, however, can adequately manage postoperative pain and minimize the risks associated with opioids. In this ...

7. janesthanalgcritcare.biomedcentral.com janesthanalgcritcare.biomedcentral.com/articles/10.1186/s44158-025-00272-9

Effectiveness and safety of opioid-free anesthesia compared ... No OFA regimens showed a statistically significant effect over OBA in reducing postoperative pain within the first 24 h following surgery.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04498559

Patient Knowledge on Pain Management and Safe Opioid ... The purpose of this study is to examine what patients currently know about opioids, including their role in pain management, side effects, risks of abuse, and ...