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

Pain, Postoperative Clinical Trial

Official title:

Transabdominal Plane (TAP) Blocks in Ventral Hernia Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02007096
• Other study ID #: GCO 12-0960
• Status: Completed
• Phase: Phase 2
• First received: December 5, 2013
• Last updated: January 17, 2018
• Start date: August 2012
• Est. completion date: October 2014

Study information

• Verified date: January 2018
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Transabdominal Plane Block
0.25% bupivacaine injection in 6 different locations in abdomen. Weight <100kg: 50ml total; weight >100kg: 60ml total
• Non Transabdominal Plane Block
Saline injection in 6 different locations in abdomen. Weight <100kg: 50ml; weight >100kg: 60ml

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative Opioid Use	Amount of opioids used by patients at certain time points.	up to 24 hours
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."	1 hour postoperatively
Secondary	Operating Procedure Time	Total number of minutes for the procedure, not including anesthesia time.	Procedure begin time to procedure end time
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."	24 hours postoperatively