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NCT Number: NCT06349772

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

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.

Recruiting

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Key information

Conditions

Post Operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location status: Recruiting

Location contact

Chad Copeland

CONTACT

[email protected]

806-743-6239

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zynrelef

Drug

Zynrelef will be injected at the 12mm port site

Exparel

Drug

Exparel will be injected at the 12mm port site

Primary outcomes

  1. postoperative pain score

    Time frame: 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 outcomes

  1. Total postoperative opioid use

    Time frame: 72 hours

    total amount of pain medications used postoperatively converted into morphine equivalents

  2. Proportion of total rescue medication use

    Time frame: 72 hours

    the amount of times a rescue medication had to be used

Study contacts

Contact information is provided by the study sponsor or research team.

Tommy Wright, DO

CONTACT

[email protected]

8176888021

Vinay Goyal, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Apr 5, 2024
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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