Autonomic Neural Blockade in Bariatric Surgery

Part of paid clinical trials in Evanston, Illinois.

Sponsor
Endeavor Health
Study ID
NCT07104825
Status
Not Yet Recruiting

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Conditions

  • Bariatric Surgery Candidate
  • Nausea and Vomiting, Postoperative
  • Opioid Use
  • Pain, Postoperative

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Intraoperative autonomic neural blockade (ANB) — PROCEDURE
    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
    Administration of local anesthetic to abdominal incisions (standard of care)

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Laparoscopic Paragastric Autonomic Neural Blockade
    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.
  • Active Comparator: Laparoscopic Standard of Care Abdominal Wall Block
    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.

Primary Outcome Measure

Pain medication consumed post-operatively [ Time Frame: Post-op 72 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Endeavor HealthEvanstonIllinois60201
Pulido Rachel
[email protected]

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