Zynrelef vs Exparel: The Battle of Postoperative Pain Con... | NCT06349772

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

NCT06349772

Sponsor

Texas Tech University Health Sciences Center

Status

Recruiting

Last Update Posted

Jul 8, 2026Actual

Enrollment

130Estimated

Phase

Early Phase 1

Conditions

Post Operative Pain

Interventions

Zynrelef
Exparel

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2024Actual

Primary Completion Date

Nov 1, 2027Estimated

Completion Date

Dec 1, 2028Estimated

First Submitted Date

Apr 1, 2024

First Submission Date that Met QC Criteria

Apr 1, 2024

First Posted Date

Apr 5, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2026

Last Update Posted Date

Jul 8, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients who receive zynrelef	Experimental	Those who get zynrelef injected at the at the 12mm port incision	Drug: Zynrelef
Patients who receive exparel	Experimental	those who get exparel injected at the 12mm port incision	Drug: Exparel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zynrelef	Drug	Zynrelef will be injected at the 12mm port site	Patients who receive zynrelef

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Total postoperative opioid use	total amount of pain medications used postoperatively converted into morphine equivalents	72 hours
Proportion of total rescue medication use	the amount of times a rescue medication had to be used

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age range: 18-65 years old
Scheduled or being scheduled to undergo robotic sleeve gastrectomy by Dr. Goyal.
Is able to provide written informed consent.
Is able to adhere to the study visit schedule and complete all study assessments.

Exclusion Criteria:

Positive urine drug screen prior to surgery
History of substance abuse in the past year-by self report
Patient with ongoing daily narcotic use at the time of surgery-by self report
Inability to understand informed consent or read English/Spanish
Pregnant or lactating patients
Prisoners
Patients with renal or hepatic failure
Bupivacaine use within 96 hours of operation
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
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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tommy Wright, DO	Contact	8176888021		tommy.wright@ttuhsc.edu
Vinay Goyal, MD	Contact			vinay.goyal@ttuhsc.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Texas Tech University Health Sciences Center	Recruiting	Lubbock	Texas	79430	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Other researchers will be involved with gathering and interpreting data

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code

Time Frame

one year

Access Criteria

Access will be given through the EMR

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided