NCT04051684

Brief Summary

Addition of transverse abdominis plane (TAP) block to general anesthesia for morbidly obese patients (BMI \>35) undergoing laparoscopic bariatric surgery for weight loss will significantly reduce opioid use in the recovery room

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2018

Completed
9 months until next milestone

First Posted

Study publicly available on registry

August 9, 2019

Completed
4 months until next milestone

Results Posted

Study results publicly available

December 3, 2019

Completed
Last Updated

December 3, 2019

Status Verified

November 1, 2019

Enrollment Period

1 month

First QC Date

November 19, 2018

Results QC Date

October 21, 2019

Last Update Submit

November 13, 2019

Conditions

Bariatric SurgeryTransverse Abdominal Plane Regional Blocks

Outcome Measures

Primary Outcomes (1)

  • Post Operative Opioid Usage

    The amounts of opioids used by the patient will be collected by a person blinded to the allocation group

    24 hour after surgery

Secondary Outcomes (3)

  • Pain Score Assessed With Visual Analog Score (VAS)

    30 minutes within arrival to PACU

  • Nausea: The Number of Participants Experiencing Nausea Will be Assessed by Chart Review

    Up to 5 hours

  • Vomiting: The Number of Participants Experiencing Vomiting Will be Assessed by Chart Review

    Up to 5 hours

Study Arms (2)

TAP, Bupivacaine

EXPERIMENTAL

This group will receive general anesthesia and at the end of the operation, but still in the operating room, a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.

Procedure: Transverse abdominal plane blockDrug: Ropivacaine

No intervention

NO INTERVENTION

General anesthesia

Interventions

Transverse abdominal plane blockPROCEDURE

Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.

Also known as: TAP
TAP, Bupivacaine
RopivacaineDRUG

Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.

TAP, Bupivacaine

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient must be 18 years of age or older and able to provide his or her own consent.
  • The patient is scheduled for bariatric surgery including laparoscopic gastric banding, sleeve gastrectomy, and gastric bypass.
  • The patient must be surgically and medically accepted for the procedure
  • Good functional status, ability to perform activities of daily living
  • The patients BMI \> 35, no upper limit
  • Signed study specific informed consent prior to enrollment

You may not qualify if:

  • Patients with an allergy to local anesthetics
  • Patients diagnosed with peripheral neuropathies including diabetes mellitus.
  • Patients with BMI \<35
  • Patients with significant coronary artery disease
  • Patient refusal of block procedure.
  • Patients with chronic pain
  • Patients on pre-operative maintenance narcotics
  • American Society of Anesthesiologist classification system 4 (ASA 4) patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Dr. Karina Gritsenko
Organization
Montefiore Medical Center
kgritsen@montefiore.org
718-920-7246

Study Officials

  • Karina Gritsenko, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 19, 2018

First Posted

August 9, 2019

Study Start

April 1, 2013

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

December 3, 2019

Results First Posted

December 3, 2019

Record last verified: 2019-11

Locations

US(1)