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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Liposomal Bupivacaine TAP block 		Patients will be randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with liposomal bupivacaine (LB). The solution used to perform the TAP block with LB will comprise of 20mL of liposomal bupivacaine solution, 30mL of 0.25% bupivacaine, and 100mL of normal saline.
  • Drug: Liposomal Bupivacaine TAP block
    Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
    Other names:
    • Exparel TAP block
Active Comparator
Regular Bupivacaine TAP block 		Patients will be randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with regular bupivacaine (RB).The solution used to perform the TAP block with RB will comprise of 50mL of 0.25% bupivacaine and 100mL of normal saline.
  • Drug: Bupivacaine TAP block
    Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
No Intervention
No TAP block 		Patients will be randomized to receive no TAP block as a control group.

More Details

Status
Completed
Sponsor
Montefiore Medical Center

Study Contact

Detailed Description

A prospective randomized controlled trial investigating the use of long acting local anesthetic for transversus abdominis block in patients undergoing bariatric surgery at Montefiore Medical Center. Patients will be randomized to either receive an intraoperative TAP block with LB, an intraoperative TAP block with RB, or no TAP block. All participants will receive standard post-operative analgesia regimen. Pain scores will be recorded by the nursing staff as reported by the patients for 24-36 hours post surgery. Patients will be monitored for secondary post-operative complications up to the 2-week mark following intervention.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.