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

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ClinicalTrials.gov Identifier: NCT02007096
Recruitment Status : Completed
First Posted : December 10, 2013
Results First Posted : January 19, 2018
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Ventral Hernia Umbilical Hernia Incisional Hernia Postoperative Complications Pain, Postoperative Drug: Transabdominal Plane Block Drug: Non Transabdominal Plane Block Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Transabdominal Plane (TAP) Blocks in Ventral Hernia Repair
Study Start Date : August 2012
Primary Completion Date : October 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
Drug Information available for: Bupivacaine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Post-operative Opioid Use [ Time Frame: up to 24 hours ]
    Amount of opioids used by patients at certain time points.


Secondary Outcome Measures :
  1. Pain Score [ Time Frame: 1 hour postoperatively ]
    Post-operative Patient Self-Reported Pain Score. Patient self-reported pain scores when resting and when actively moving. Scale of 0 to 10, with 0 being "no pain" and 10 being "the most pain you have ever experienced."

  2. Operating Procedure Time [ Time Frame: Procedure begin time to procedure end time ]
    Total number of minutes for the procedure, not including anesthesia time.

  3. Pain Score [ Time Frame: 24 hours postoperatively ]
    Post-operative Patient Self-Reported Pain Score. Patient self-reported pain scores when resting and when actively moving. Scale of 0 to 10, with 0 being "no pain" and 10 being "the most pain you have ever experienced."


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02007096


Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Celia M Divino, MD, FACS Icahn School of Medicine at Mount Sinai
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Celia M. Divino, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02007096     History of Changes
Other Study ID Numbers: GCO 12-0960
First Posted: December 10, 2013    Key Record Dates
Results First Posted: January 19, 2018
Last Update Posted: January 19, 2018
Last Verified: January 2018

Keywords provided by Celia M. Divino, Icahn School of Medicine at Mount Sinai:
Transabdominal plane block
ventral hernia
umbilical hernia
incisional hernia
hernia repair

Additional relevant MeSH terms:
Hernia
Postoperative Complications
Pain, Postoperative
Hernia, Ventral
Incisional Hernia
Hernia, Umbilical
Pathological Conditions, Anatomical
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hernia, Abdominal
Infant, Newborn, Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents