Autonomic Neural Blockade in Bariatric Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorEndeavor Health

About this trial

The purpose of this research is to evaluate if autonomic nerve block (ANB- blocking pain and nausea signals) decreases pain and anti-nausea medication requirements as well as the experience of pain/nausea during the first 72 hours after sleeve gastrectomy or gastric bypass surgery. Participants will be randomly assigned either to the standard of care or the ANB group before surgery. As part of standard of care, in both groups, laparoscopic bariatric surgery will be initiated with local anesthetic injected into the abdominal wall. In the ANB group, participants will be given an additional injection of local anesthetic medication to block nerves on and around the stomach.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Adults, ages 18-90

All patients with severe obesity undergoing laparoscopic/robotic gastric bypass or sleeve gastrectomy

Disqualifiers

Patients taking opiates chronically

Patients allergic to study medications

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

Adults unable to consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intraoperative autonomic neural blockade (ANB)

    Procedure/Surgery

    Local anesthetic block of the neurovascular tissue along the lesser curve of the stomach and celiac trunk during sleeve gastrectomy or gastric bypass surgery.

  • Laparoscopic Standard of Care Abdominal Wall Block

    Procedure/Surgery

    Administration of local anesthetic to abdominal incisions (standard of care)

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Laparoscopic Paragastric Autonomic Neural BlockadeExperimental treatment 1 intervention
Group B: Laparoscopic Standard of Care Abdominal Wall BlockActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain medication consumed post-operatively

Total Morphine milligram equivalents (MMEs) of pain medication utilized during the first 72hrs after bariatric surgery

Time frame
Post-op 72 hours

Secondary outcomes

1

Numerical Pain Rating Scale

Numerical pain scale from 0 (no pain) to 10 (worst pain possible)

Time frame
Day of surgery, post-op days 1, 2 and 3.
2

Nausea, retching and vomiting symptoms

Proportion of patients reporting nausea, retching and vomiting on post-op days 1, 2 and 3.

Time frame
Post-op days 1, 2 and 3.

Other outcomes

Sponsors and contacts

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