Phase 2 N=219 Randomized Triple-blind Treatment

Liposomal Bupivacaine in Bariatric Surgery

Bariatric Surgery Analgesia

Bottom Line

View on ClinicalTrials.gov: NCT03373591 ↗

Enrolled (actual)

219

Serious AEs

0.0%

Results posted

Nov 2019

Primary outcome: Primary: Fentanyl PCA mcg — 351.4; 360.7; 353.9 Micrograms

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Liposomal Bupivacaine TAP block (Drug); Bupivacaine TAP block (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Montefiore Medical Center
Primary completion: Jun 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Fentanyl PCA mcg	351.4; 360.7; 353.9	—
PRIMARY Total Fentanyl Usage	424.1; 434.2; 427.5	—
SECONDARY Acetaminophen Usage	486.4; 501.0; 353.4	—
SECONDARY NSAID Usage	14.2; 42.5; 21.3	—
SECONDARY Pain Score	4.3; 4.7; 4.7	—
SECONDARY Length of Stay	42; 44; 46; 26; 26; 25	—
SECONDARY Nausea	27; 41; 34	—
SECONDARY Time to Ambulation	51; 60; 59	—

Summary

The aim of this study is to perform a randomized controlled trial for patients undergoing bariatric surgery, comparing the need for opiates with and without administration of a transversus abdominis plane (TAP) block using the long acting local anesthetic, liposomal bupivacaine (Exparel®). From this study, the investigators will assess whether use of long acting local anesthetic can reduce the need for opiates in the bariatric population.

Eligibility Criteria

Inclusion Criteria

Obese patients undergoing bariatric surgery (LSG or LRYGB)
Patients 18 years of age and older
Surgical treatment between 01/01/2018 and 12/31/2018 over a 1 year period

Exclusion Criteria

Patients under the age of 18 years old
Patients taking any opiates within 30 days of enrollment in the trial
Patients with a history of chronic pain.
Patients taking pregabalin or gabapentin.
ASA IV
Prior laparotomy
Body Mass Index ≥ 60 kg/m2
History of cardiac arrhythmia
History of Seizure
Psychiatric Diagnosis currently on antipsychotic medication

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03373591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.