Bariatric Surgery Candidate, Nausea and Vomiting, Postoperative, Opioid Use, Pain, Postoperative
Conditions
Keywords
Autonomic, blockade, bariatric surgery
Brief summary
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.
Detailed description
Gastric bypass and sleeve gastrectomy are the most common and successful weight loss surgeries. The advancement of laparoscopic, minimally invasive techniques allows these procedures to be performed with low morbidity and a relatively easy recovery, when broadly considering abdominal surgery. The major complaints postoperatively are abdominal pain and nausea, which can require medications to control and may prolong hospital stay. 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 surgical environment providing extended analgesia for pain following surgery. This study is a single-blinded randomized controlled trial comparing the total morphine milligram equivalents (MMEs) of pain medication used 72 hours post-operative period in patients who received the ANB vs standard of care. In the ANB group, additional local anesthetic block of the neurovascular tissue along the lesser curve of the stomach and celiac trunk will be performed using 0.5% bupivacaine 10ml, 50mg and Liposomal bupivacaine 10ml, 133mg dose. Study participants will not be told if they received the block, but the surgeon will be aware of which study group participants are assigned.
Interventions
PROCEDUREIntraoperative autonomic neural blockade (ANB)
Local anesthetic block of the neurovascular tissue along the lesser curve of the stomach and celiac trunk during sleeve gastrectomy or gastric bypass surgery.
PROCEDURELaparoscopic Standard of Care Abdominal Wall Block
Administration of local anesthetic to abdominal incisions (standard of care)
Sponsors
Endeavor Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The study participants will be blinded to treatment arm assignments.
Intervention model description
A single-blinded randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Pregnant women * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain medication consumed post-operatively | Post-op 72 hours | Total Morphine milligram equivalents (MMEs) of pain medication utilized during the first 72hrs after bariatric surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Pain Rating Scale | Day of surgery, post-op days 1, 2 and 3. | Numerical pain scale from 0 (no pain) to 10 (worst pain possible) |
| Nausea, retching and vomiting symptoms | Post-op days 1, 2 and 3. | Proportion of patients reporting nausea, retching and vomiting on post-op days 1, 2 and 3. |
Countries
United States
Contacts
CONTACTHerbert Hedberg, MD
PRINCIPAL_INVESTIGATORHerbert Hedberg, MD
Endeavor Health
Outcome results
None listed