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OpenTrials
Completed

NCT Number: NCT02007096

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

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.

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Key information

Conditions

Ventral Hernia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hernia Hernia, Abdominal Hernia, Umbilical Hernia, Ventral Incisional Hernia Infant, Newborn, Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Umbilical Hernia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Transabdominal Plane Block

Drug

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

Other names: Bupivacaine

Non Transabdominal Plane Block

Drug

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

Other names: Saline

Primary outcomes

  1. Post-operative Opioid Use

    Time frame: up to 24 hours

    Amount of opioids used by patients at certain time points.

Secondary outcomes

  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."

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Transabdominal Plane (TAP) Blocks in Ventral Hernia Repair

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 10, 2013
Registry last updated
Jan 19, 2018

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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