Autonomic Neural Blockade for Postoperative Symptoms in Bariatric Surgery

Overseen By Herbert Hedberg, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Endeavor Health

Must not be taking: Opiates

Disqualifiers: Allergy to study meds, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to manage pain and nausea after weight-loss surgery. It examines whether a special nerve block, known as intraoperative autonomic neural blockade (ANB), can reduce the need for pain and anti-nausea medications in the days following surgery. Participants will receive either the usual care or this new nerve block during their operation. Suitable candidates include those with severe obesity planning to undergo specific weight-loss surgeries, such as gastric bypass or sleeve gastrectomy. As an unphased trial, this study provides a unique opportunity to explore innovative pain management techniques post-surgery.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking opiates regularly, you cannot participate in the trial.

What prior data suggests that autonomic neural blockade is safe for bariatric surgery patients?

Research has shown that intraoperative autonomic neural blockade (ANB) is safe during surgery. ANB helps control pain and reduces the need for pain medications, such as opioids, after surgery. Studies indicate that patients tolerate ANB well, with no serious side effects reported. This suggests that ANB can manage pain and nausea without harming patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the autonomic neural blockade (ANB) for postoperative symptoms in bariatric surgery because it offers a novel approach compared to standard care, which typically involves local anesthetic injections at incision sites. Unlike traditional methods that focus solely on numbing the incision area, ANB specifically targets the autonomic nerves along the perigastric tissues and celiac trunk, which may play a role in postoperative pain and recovery. This targeted approach could potentially lead to better pain management and faster recovery times. Additionally, the use of both standard and liposomal bupivacaine in the ANB method allows for sustained pain relief, which is a significant step forward in enhancing the postoperative experience for bariatric surgery patients.

What evidence suggests that autonomic neural blockade is effective for reducing postoperative symptoms in bariatric surgery?

This trial will compare the effectiveness of intraoperative autonomic neural blockade (ANB) with the standard of care for managing postoperative symptoms in bariatric surgery. Research has shown that ANB can effectively reduce pain and nausea after surgery. Studies have found that ANB decreases the need for painkillers, especially opioids, following weight-loss surgery. ANB blocks nerve signals that cause pain and nausea, making recovery more comfortable. This treatment has proven safe and effective in managing these symptoms immediately after surgery, helping to ease discomfort and lessen the need for pain medications. ^{1 2 3 6 7}

Who Is on the Research Team?

Herbert Hedberg, MD

Principal Investigator

Endeavor Health

Are You a Good Fit for This Trial?

This trial is for individuals undergoing sleeve gastrectomy or gastric bypass surgery who may experience postoperative pain and nausea. It's not suitable for those with opioid use disorder or other conditions that would exclude them from safely participating.

Inclusion Criteria

I am between 18 and 90 years old.

Individuals able and willing to consent and participate in all study activities

I am severely obese and planning to have weight loss surgery.

Exclusion Criteria

Patients taking opiates chronically

Patients allergic to study medications

Patients with any prior adverse reaction to ingredients included in the block

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo laparoscopic bariatric surgery with either standard care or additional autonomic neural blockade

1 day

1 visit (in-person)

Immediate Post-operative Monitoring

Participants are monitored for pain and nausea, and pain medication usage is recorded for 72 hours post-surgery

3 days

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on nausea and pain symptoms

1 week

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Intraoperative autonomic neural blockade (ANB)

Trial Overview The study tests if autonomic nerve block (ANB), which aims to block pain and nausea signals, can reduce the need for anti-nausea medication and lessen pain/nausea after bariatric surgery compared to standard care.

How Is the Trial Designed?

Group I: Laparoscopic Paragastric Autonomic Neural Blockade Experimental Treatment 1 Intervention

ANB will be performed in addition to administration of local anesthetic to abdominal incisions (standard of care). The block is administered via syringe attached to IV tubing and 25g hypodermic needle. The needle and tubing are introduced through a laparoscopic port with the cap in place, and the needle is grasped and cap removed in the abdomen. The needle is advance into perigastric tissue along the lesser curve, the lack of vascular penetration is confirmed with aspiration, and the anesthetic (0.5% bupivacaine-10ml, 50mg and Liposomal bupivacaine-10ml, 133mg) is injected. 10ml is distributed along the lesser curve, and 5ml on either side of the celiac trunk, identified by dividing the lesser omentum and elevating the stomach.

Group II: Laparoscopic Standard of Care Abdominal Wall Block Active Control 1 Intervention

Laparoscopic bariatric surgeries are performed with local anesthetic injected into the abdominal wall only. This may be with transversus abdominis block or local injection at the port sites. At our institution, standard of care is local injection at port sites with bupivacaine (30ml) spread among the five small incisions. This standard will be maintained for every patient in the study.

Who Is Running the Clinical Trial?

Endeavor Health

Lead Sponsor

Trials

135

Recruited

742,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40032662/

Intraoperative autonomic neural blockade: comparison ... Intraoperative autonomic neural blockade (ANB) has demonstrated efficacy in addressing these issues, with the duration of the effect its most important ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07104825

Autonomic Neural Blockade in Bariatric Surgery There is evidence autonomic neural blockade (ANB) improves pain and nausea in the immediate postoperative period. ANB has been shown to be therapeutic in the ...

3. journals.lww.com journals.lww.com/anesthesia-analgesia/fulltext/2024/09000/impact_on_anesthetic_agent_consumption_after.16.aspx

Impact on Anesthetic Agent Consumption After Autonomic... The intraoperative autonomic neural blockade (ANB) was found safe and effective in controlling pain and associated symptoms and reducing analgesic ...

4. liebertpub.com liebertpub.com/doi/full/10.1089/bari.2023.0038?doi=10.1089/bari.2023.0038

Impact of Autonomic Neural Blockade Timing During ... Conclusions: ANB safely and effectively reduces postoperative pain, PONV, and the need for analgesics, especially opioids after LSG, regardless of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11305619/

Impact on Anesthetic Agent Consumption After Autonomic ... The intraoperative autonomic neural blockade (ANB) was found safe and effective in controlling pain and associated symptoms and reducing ...

6. liebertpub.com liebertpub.com/doi/10.1089/bari.2023.0038

Impact of Autonomic Neural Blockade Timing During ... Conclusions: ANB safely and effectively reduces postoperative pain, PONV, and the need for analgesics, especially opioids after LSG, regardless of ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38091501/

Impact on Anesthetic Agent Consumption After Autonomic ... The intraoperative autonomic neural blockade (ANB) was found safe and effective in controlling pain and associated symptoms and reducing ...