Does a Transabdominal Plane Block Decrease Patient Pain After Ventral Hernia Repair?

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Mount Sinai School of Medicine
Sponsor:
Information provided by (Responsible Party):
Celia M. Divino, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT02007096
First received: December 5, 2013
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Transabdominal Plane Block
Ventral Hernia
Umbilical Hernia
Incisional Hernia
Drug: Transabdominal Plane Block
Drug: Non Transabdominal Plane Block
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Transabdominal Plane (TAP) Blocks in Ventral Hernia Repair

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Post-operative Opioid Use [ Time Frame: up to 3 weeks ] [ Designated as safety issue: No ]
    Amount of opioids used by patients at certain time points.


Secondary Outcome Measures:
  • Pain Score [ Time Frame: up to 3 weeks ] [ Designated as safety issue: No ]
    Post-operative Patient Self-Reported Pain Score. Patient self-reported pain scores when resting and when actively moving.

  • Operating Procedure Time [ Time Frame: Procedure begin time to procedure end time ] [ Designated as safety issue: No ]
    Total number of minutes for the procedure, not including anesthesia time.


Estimated Enrollment: 200
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transabdominal Plane Block
Receiving Transabdominal Plane Block with 0.25% bupivacaine
Drug: Transabdominal Plane Block
0.25% bupivacaine injection in 6 different locations in abdomen. Weight <100kg: 50ml total; weight >100kg: 60ml total
Other Name: Bupivacaine
Placebo Comparator: Non Transabdominal Plane Block
Receiving placebo saline injection
Drug: Non Transabdominal Plane Block
Saline injection in 6 different locations in abdomen. Weight <100kg: 50ml; weight >100kg: 60ml
Other Name: Saline

Detailed Description:

Patients coming in for a laparoscopic ventral (ventral, umbilical, incisional) hernia repair with mesh are randomized to either receive a Transabdominal Plane Block injection or a placebo saline injection. The injection will be performed by surgeons under direct visualization during laparoscopic surgery prior to mesh placement. Patients will be followed up post-operatively and after hospital discharge to assess for opioid usage and pain score. Patients in both arms are medically cleared by the surgeon. Currently there are no studies that look at the use of Transabdominal Plane Block in ventral hernia repairs.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • age younger than 18
  • allergic reaction to bupivacaine
  • allergic reaction to opioids
  • opioid substance abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02007096

Contacts
Contact: Celia M Divino, MD, FACS 212-241-3348 celia.divino@mountsinai.org
Contact: Emily W Shi, MD 212-241-4746 emily.shi@mountsinai.org

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Emily W Shi, MD    212-241-4746    Emily.shi@mountsinai.org   
Principal Investigator: Celia M Divino, MD, FACS         
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Celia M Divino, MD, FACS Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Celia M. Divino, Professor, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT02007096     History of Changes
Other Study ID Numbers: GCO 12-0960
Study First Received: December 5, 2013
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Transabdominal plane block
ventral hernia
umbilical hernia
incisional hernia
hernia repair

Additional relevant MeSH terms:
Hernia, Umbilical
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal
Infant, Newborn, Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014