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Completed

NCT Number: NCT03373591

Liposomal Bupivacaine in Bariatric Surgery

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.

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Key information

Conditions

Bariatric Surgery Analgesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Liposomal Bupivacaine TAP block

Drug

Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.

Other names: Exparel TAP block

Bupivacaine TAP block

Drug

Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.

Primary outcomes

  1. Fentanyl PCA mcg

    Time frame: 24 hours post surgery.

    Fentanyl PCA (patient controlled analgesia) total microgram usage.

  2. Total Fentanyl Usage

    Time frame: During hospitalization, up to 7 days.

    Total fentanyl usage in micrograms, including both PCA and IV push administered medication.

Secondary outcomes

  1. Acetaminophen Usage

    Time frame: During hospitalization, up t 7 days.

    Total amount of acetaminophen used for analgesia.

  2. NSAID Usage

    Time frame: During hospitalization, up to 7 days.

    Total amount of NSAID (ketorolac) use for analgesia.

  3. Pain Score

    Time frame: 24 hours post surgery.

    Patient reported composite measure pain score, with a total range of 0 to 10, with 0 being the absence of pain, 1 being the least amount of pain and 10 being the highest amount of pain.

  4. Length of Stay

    Time frame: Assessed every 24 hours post surgery, up to 168 hour post-surgery.

    Hours of hospitalization post-surgery

  5. Nausea

    Time frame: 24 hours post surgery.

    Number of participants with presence or absence of nausea reported and recorded by the nurse.

  6. Time to Ambulation

    Time frame: Assessed every 24 hours post surgery, up to 168 hour post-surgery.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

Randomized Controlled Trial Investigating Use of Liposomal Bupivacaine in Bariatric Surgery

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 14, 2017
Registry last updated
Nov 4, 2019

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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