Post Operative Pain
Conditions
Keywords
robotic surgery, sleeve gastrectomy, zynrelef, exparel
Brief summary
The purpose of this study is to evaluate the use of an injectable combination of bupivacaine and meloxicam (Zynrelef) vs injectable liposomal bupivacaine (Exparel), two extended local anesthesia strategies currently approved by FDA and on the market for post-surgical pain control. The investigators plan on randomizing study participants to either Exparel or Zynrelef at the closure site of robotic sleeve gastrectomy and assessing their pain control postoperatively both in the hospital and at home. The investigators will measure the outcome of two drugs, Zynrelief, and Exparel on postoperative pain score -using the NRS pin score up to 72 hours after surgery. The total opioid use will be recorded in forms that will be used to measure pain score and total opioid use and will be collected to the Excel sheet. The cost of the drug will be calculated for internal use for Hospital purpose only.
Interventions
DRUGZynrelef
Zynrelef will be injected at the 12mm port site
DRUGExparel
Exparel will be injected at the 12mm port site
Sponsors
Texas Tech University Health Sciences Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
randomizing study participants to either Exparel or Zynrelef at the closure site of robotic sleeve gastrectomy and assessing their pain control postoperatively
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age range: 18-65 years old 2. Scheduled or being scheduled to undergo robotic sleeve gastrectomy by Dr. Goyal. 3. Is able to provide written informed consent. 4. Is able to adhere to the study visit schedule and complete all study assessments.
Exclusion criteria
1. Positive urine drug screen prior to surgery 2. History of substance abuse in the past year-by self report 3. Patient with ongoing daily narcotic use at the time of surgery-by self report 4. Inability to understand informed consent or read English/Spanish 5. Pregnant or lactating patients 6. Prisoners 7. Patients with renal or hepatic failure 8. Bupivacaine use within 96 hours of operation 9. Patient intolerant of opiates, nonsteroidal anti-inflammatory drug s, acetaminophen, or Zynrelef and Exparel. Subjects in all cohorts must not have any contraindications to any of the protocol-specified drugs 10. Patient with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pain score | 72 hours | this will be measured using a numerical rating scale. The scale is 0-10 with 0 being no pain and 10 being the worst pain of their life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total postoperative opioid use | 72 hours | total amount of pain medications used postoperatively converted into morphine equivalents |
| Proportion of total rescue medication use | 72 hours | the amount of times a rescue medication had to be used |
Countries
United States
Contacts
CONTACTTommy Wright, DO
CONTACTVinay Goyal, MD
Outcome results
None listed