Zynrelef vs Exparel: The Battle of Postoperative Pain Control After Robotic Sleeve Gastrectomy

Post Operative Pain Clinical Trial

Official title:

Zynrelef vs Exparel: The Battle of Postoperative Pain Control After Robotic Sleeve Gastrectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06349772
• Other study ID #: FY2024-203
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: November 1, 2024
• Est. completion date: April 1, 2025

Study information

• Verified date: May 2024
• Source: Texas Tech University Health Sciences Center
• Contact: Tommy Wright, DO
• Phone: 8176888021
• Email: tommy.wright[@]ttuhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Zynrelef
Zynrelef will be injected at the 12mm port site
• Exparel
Exparel will be injected at the 12mm port site

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain score	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	72 hours
Secondary	Total postoperative opioid use	total amount of pain medications used postoperatively converted into morphine equivalents	72 hours
Secondary	Proportion of total rescue medication use	the amount of times a rescue medication had to be used	72 hours