A Phase 2 interventional study of Transabdominal Plane Block and Non Transabdominal Plane Block in Ventral Hernia, Umbilical Hernia and Incisional Hernia, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-19.
Sponsored by Icahn School of Medicine at Mount Sinai · Phase 2, Interventional, and Supportive care
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.
67 studies on the registry are indexed under Hernia, Umbilical; 13 are open to participants now.
This study's enrollment of 127 is above the median of 66 across 40 interventional studies indexed under Hernia, Umbilical.
Browse Hernia, Umbilical studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 83 (66%) have results posted.
Compared within Hernia, Umbilical, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hernia, Ventral. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Receiving Transabdominal Plane Block with 0.25% bupivacaine
Drug: Transabdominal Plane Block
Receiving placebo saline injection
Drug: Non Transabdominal Plane Block
0.25% bupivacaine injection in 6 different locations in abdomen. Weight \<100kg: 50ml total; weight \>100kg: 60ml total
Also known as: Bupivacaine
Saline injection in 6 different locations in abdomen. Weight \<100kg: 50ml; weight \>100kg: 60ml
Also known as: Saline
Post-operative Opioid Use
Amount of opioids used by patients at certain time points.
Time frame: up to 24 hours
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."
Time frame: 1 hour postoperatively
Operating Procedure Time
Total number of minutes for the procedure, not including anesthesia time.
Time frame: 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."
Time frame: 24 hours postoperatively
Participants recruited from the Department of Surgery at The Mount Sinai Hospital between November 2012 and October 2014.
| Milestone | Transabdominal Plane Block | Non Transabdominal Plane Block |
|---|---|---|
| Started | 63 | 64 |
| Completed | 52 | 48 |
| Not completed | 11 | 16 |
| Withdrew: Medication not available | 2 | 0 |
| Withdrew: Did not inject saline | 0 | 3 |
| Withdrew: Did not follow postoperative protocol | 8 | 11 |
| Withdrew: Converted to open surgery | 1 | 1 |
| Withdrew: No mesh placed | 0 | 1 |
Amount of opioids used by patients at certain time points.
| mg | Transabdominal Plane Block | Non Transabdominal Plane Block |
|---|---|---|
| at 6 hours | 10.59 ± 0 | 15.62 ± 0 |
| at 12 hours | 16.09 ± 0 | 32.24 ± 0 |
| at 18 hours | 20.70 ± 0 | 39.37 ± 0 |
| at 24 hours | 25.64 ± 0 | 42.56 ± 0 |
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."
| units on a scale | Transabdominal Plane Block | Non Transabdominal Plane Block |
|---|---|---|
| pain scores at rest | 5.19 ± 0.39 | 6.46 ± 0.38 |
| pain scores with movement | 6.15 ± 0.42 | 7.73 ± 0.40 |
Total number of minutes for the procedure, not including anesthesia time.
| min | Transabdominal Plane Block | Non Transabdominal Plane Block |
|---|---|---|
| Operating Procedure Time | 97.41 ± 30.22 | 98.81 ± 37.51 |
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."
| units on a scale | Transabdominal Plane Block | Non Transabdominal Plane Block |
|---|---|---|
| pain scores at rest | 4.60 ± 0.39 | 4.52 ± 0.31 |
| pain scores with movement | 6.75 ± 0.38 | 6.98 ± 0.40 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Transabdominal Plane Block | — | — | — |
| Non Transabdominal Plane Block | — | — | — |
| Age, Continuous(years) | Transabdominal Plane Block | Non Transabdominal Plane Block | Total |
|---|---|---|---|
| Mean | 52.67 ± 12.89 | 53.81 ± 13.45 | 53.22 ± 13.11 |
| Sex: Female, Male(Participants) | Transabdominal Plane Block | Non Transabdominal Plane Block | Total |
|---|---|---|---|
| Female | 27 | 21 | 48 |
| Male | 25 | 27 | 52 |
| BMI(kg/m^2) | Transabdominal Plane Block | Non Transabdominal Plane Block | Total |
|---|---|---|---|
| Mean | 30.91 ± 5.45 | 31.16 ± 7.00 | 31.03 ± 6.21 |
| ASA class(Participants) | Transabdominal Plane Block | Non Transabdominal Plane Block | Total |
|---|---|---|---|
| 1 | 7 | 6 | 13 |
| 2 | 24 | 24 | 48 |
| 3 | 20 | 16 | 36 |
| 4 | 1 | 2 | 3 |
| Hypertension(Participants) | Transabdominal Plane Block | Non Transabdominal Plane Block | Total |
|---|---|---|---|
| Count of participants | 25 | 23 | 48 |
| Diabetes(Participants) | Transabdominal Plane Block | Non Transabdominal Plane Block | Total |
|---|---|---|---|
| Count of participants | 10 | 9 | 19 |
| Hyperlipidemia(Participants) | Transabdominal Plane Block | Non Transabdominal Plane Block | Total |
|---|---|---|---|
| Count of participants | 14 | 20 | 34 |
| Coronary artery disease(Participants) | Transabdominal Plane Block | Non Transabdominal Plane Block | Total |
|---|---|---|---|
| Count of participants | 6 | 9 | 15 |
6 further baseline measures are reported on the registry.
The record gives a start of Aug 2012, a primary completion of Oct 2014 and a completion of Oct 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2018, 3 years 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bupivacaine
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