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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTexas Tech University Health Sciences Center

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Zynrelef

    Drug

    Zynrelef will be injected at the 12mm port site

  • Exparel

    Drug

    Exparel will be injected at the 12mm port site

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Patients who receive zynrelefExperimental treatment 1 intervention
Group B: Patients who receive exparelExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
72 hours

Secondary outcomes

1

Total postoperative opioid use

total amount of pain medications used postoperatively converted into morphine equivalents

Time frame
72 hours
2

Proportion of total rescue medication use

the amount of times a rescue medication had to be used

Time frame
72 hours

Other outcomes

Sponsors and contacts

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