NCT02007096

Brief Summary

The purpose of this study is to determine if a Transabdominal Plane Block will decrease patient pain and pain medication use after a laparoscopic ventral (ventral, umbilical, incisional) hernia repair with mesh.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
127

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2012

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

August 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

January 19, 2018

Completed
Last Updated

January 19, 2018

Status Verified

January 1, 2018

Enrollment Period

2.2 years

First QC Date

December 5, 2013

Results QC Date

April 3, 2017

Last Update Submit

January 17, 2018

Conditions

Ventral HerniaUmbilical HerniaIncisional HerniaPostoperative ComplicationsPain, Postoperative

Keywords

Transabdominal plane blockventral herniaumbilical herniaincisional herniahernia repair

Outcome Measures

Primary Outcomes (1)

  • Post-operative Opioid Use

    Amount of opioids used by patients at certain time points.

    up to 24 hours

Secondary Outcomes (3)

  • Pain Score

    1 hour postoperatively

  • Operating Procedure Time

    Procedure begin time to procedure end time

  • Pain Score

    24 hours postoperatively

Study Arms (2)

Transabdominal Plane Block

EXPERIMENTAL

Receiving Transabdominal Plane Block with 0.25% bupivacaine

Drug: Transabdominal Plane Block

Non Transabdominal Plane Block

PLACEBO COMPARATOR

Receiving placebo saline injection

Drug: Non Transabdominal Plane Block

Interventions

Transabdominal Plane BlockDRUG

0.25% bupivacaine injection in 6 different locations in abdomen. Weight \<100kg: 50ml total; weight \>100kg: 60ml total

Also known as: Bupivacaine
Transabdominal Plane Block
Non Transabdominal Plane BlockDRUG

Saline injection in 6 different locations in abdomen. Weight \<100kg: 50ml; weight \>100kg: 60ml

Also known as: Saline
Non Transabdominal Plane Block

Eligibility Criteria

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

You may qualify if:

  • age 18 and older
  • elective laparoscopic ventral (ventral, umbilical, incisional) hernia repair at Mount Sinai Hospital

You may not qualify if:

  • age younger than 18
  • allergic reaction to bupivacaine
  • allergic reaction to opioids
  • opioid substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

  • Fields AC, Gonzalez DO, Chin EH, Nguyen SQ, Zhang LP, Divino CM. Laparoscopic-Assisted Transversus Abdominis Plane Block for Postoperative Pain Control in Laparoscopic Ventral Hernia Repair: A Randomized Controlled Trial. J Am Coll Surg. 2015 Aug;221(2):462-9. doi: 10.1016/j.jamcollsurg.2015.04.007. Epub 2015 Apr 22.

    PMID: 26206644DERIVED

MeSH Terms

Conditions

Hernia, VentralHernia, UmbilicalIncisional HerniaPostoperative ComplicationsPain, Postoperative

Interventions

BupivacaineSodium Chloride

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Limitations and Caveats

The surgeon knew the group assignment to administer the correct injection. Data not collected on clinical difference, e.g. postop nausea \& vomiting. Study conducted at one center with experienced surgeons, so the results might not be generalizable.

Results Point of Contact

Title
Dr. Celia M Divino
Organization
Division of General Surgery, Department of Surgery, The Mount Sinai Medical Center
Celia.Divino@mountsinai.org
212-241-5499

Study Officials

  • Celia M Divino, MD, FACS

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 5, 2013

First Posted

December 10, 2013

Study Start

August 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

January 19, 2018

Results First Posted

January 19, 2018

Record last verified: 2018-01

Locations

US(1)