Clinical trial NCT06349772: Zynrelef vs Exparel: The Battle of Postoperative Pain Control After Robotic Sleeve Gastrectomy
Official title: Zynrelef vs Exparel: The Battle of Postoperative Pain Control After Robotic Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Post Operative Pain
Keywords: robotic surgery
sleeve gastrectomy
zynrelef
exparel
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: postoperative pain score
timeFrame: 72 hours
Secondary outcomes:
measure: Total postoperative opioid use
timeFrame: 72 hours
measure: Proportion of total rescue medication use
timeFrame: 72 hours
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
References: