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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Transabdominal Plane (TAP) Blocks in Ventral Hernia Repair

Conditions
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Ventral Hernia, Umbilical Hernia, Incisional Hernia, Postoperative Complications, Pain, Postoperative

Intervention / Treatment
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* Drug: Transabdominal Plane Block
* Drug: Non Transabdominal Plane Block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transabdominal Plane Block<br>Receiving Transabdominal Plane Block with 0.25% bupivacaine | Drug: Transabdominal Plane Block<br>* 0.25% bupivacaine injection in 6 different locations in abdomen. Weight <100kg: 50ml total; weight >100kg: 60ml total<br>* Other names: Bupivacaine;|
| Placebo Comparator: Non Transabdominal Plane Block<br>Receiving placebo saline injection | Drug: Non Transabdominal Plane Block<br>* Saline injection in 6 different locations in abdomen. Weight <100kg: 50ml; weight >100kg: 60ml<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Opioid Use | Amount of opioids used by patients at certain time points. | up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | 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. | 1 hour postoperatively | 
| Operating Procedure Time | Total number of minutes for the procedure, not including anesthesia time. | Procedure begin time to procedure end time | 
| Pain Score | 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. | 24 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ventral hernia, Transabdominal plane block, umbilical hernia, incisional hernia, hernia repair