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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transabdominal Plane Block | Experimental | Receiving Transabdominal Plane Block with 0.25% bupivacaine |
|
| Non Transabdominal Plane Block | Placebo Comparator | Receiving placebo saline injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transabdominal Plane Block | Drug | 0.25% bupivacaine injection in 6 different locations in abdomen. Weight <100kg: 50ml total; weight >100kg: 60ml total |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Opioid Use | Amount of opioids used by patients at certain time points. | up to 24 hours |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Celia M Divino, MD, FACS | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26206644 | Derived | 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. |
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Participants recruited from the Department of Surgery at The Mount Sinai Hospital between November 2012 and October 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Transabdominal Plane Block | Transabdominal Plane Block with 0.25% bupivacaine |
| FG001 | Non Transabdominal Plane Block | Non Transabdominal Plane Block: Saline injection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Non Transabdominal Plane Block | Drug | Saline injection in 6 different locations in abdomen. Weight <100kg: 50ml; weight >100kg: 60ml |
|
|
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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Transabdominal Plane Block | Transabdominal Plane Block with 0.25% bupivacaine |
| BG001 | Non Transabdominal Plane Block | Non Transabdominal Plane Block: Saline injection |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| BMI | Body Mass Index | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||
| ASA class | Preoperative American Society of Anesthesia (ASA) scores to evaluate the degree of a patient's "sickness" or "physical state" before selecting the anesthetic or before performing surgery, with one being normal to five being severely impaired. | Count of Participants | Participants |
| |||||||||||||||
| Hypertension | Count of Participants | Participants |
| ||||||||||||||||
| Diabetes | Count of Participants | Participants |
| ||||||||||||||||
| Hyperlipidemia | Count of Participants | Participants |
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| Coronary artery disease | Count of Participants | Participants |
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| GERD | Gastroesophageal reflux disease | Count of Participants | Participants |
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| Smoker | Count of Participants | Participants |
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| Previous abdominal surgery | Count of Participants | Participants |
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| Hernia defect size | Mean | Standard Deviation | cm^2 |
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| Location of hernia defect | Count of Participants | Participants |
| ||||||||||||||||
| LOS | length of stay | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-operative Opioid Use | Amount of opioids used by patients at certain time points. | Posted | Mean | Standard Deviation | mg | up to 24 hours |
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| Secondary | 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." | Posted | Mean | Standard Deviation | units on a scale | 1 hour postoperatively |
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| Secondary | Operating Procedure Time | Total number of minutes for the procedure, not including anesthesia time. | Posted | Mean | Standard Deviation | min | Procedure begin time to procedure end time |
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| Secondary | 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." | Posted | Mean | Standard Deviation | units on a scale | 24 hours postoperatively |
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Adverse Events information not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transabdominal Plane Block | Transabdominal Plane Block with 0.25% bupivacaine | 0 | 0 | 0 | 0 | ||
| EG001 | Non Transabdominal Plane Block | Non Transabdominal Plane Block: Saline injection | 0 | 0 | 0 | 0 |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Celia M Divino | Division of General Surgery, Department of Surgery, The Mount Sinai Medical Center | 212-241-5499 | Celia.Divino@mountsinai.org |
| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| D006554 | Hernia, Umbilical |
| D000069290 | Incisional Hernia |
| D011183 | Postoperative Complications |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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| Male |
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| 2 |
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| 3 |
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| 4 |
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| Umbilical |
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| Infraumbilical |
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| Lateral |
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| ≥2 days |
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| at 18 hours |
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| at 24 hours |
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