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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||127 participants|
|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|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
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
- Post-operative Opioid Use [ Time Frame: up to 24 hours ]Amount of opioids used by patients at certain time points.
- 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."
- Operating Procedure Time [ Time Frame: Procedure begin time to procedure end time ]Total number of minutes for the procedure, not including anesthesia time.
- 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."
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
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Celia M Divino, MD, FACS||Icahn School of Medicine at Mount Sinai|