Incisional Hernia, Pain, Postoperative, Postoperative Complications, Umbilical Hernia, Ventral Hernia
Conditions
Keywords
Transabdominal plane block, ventral hernia, umbilical hernia, incisional hernia, hernia repair
Brief 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.
Detailed 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.
Interventions
0.25% bupivacaine injection in 6 different locations in abdomen. Weight \<100kg: 50ml total; weight \>100kg: 60ml total
DRUGNon Transabdominal Plane Block
Saline injection in 6 different locations in abdomen. Weight \<100kg: 50ml; weight \>100kg: 60ml
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Opioid Use | up to 24 hours | Amount of opioids used by patients at certain time points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | 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 | Procedure begin time to procedure end time | Total number of minutes for the procedure, not including anesthesia time. |
Countries
United States
Participant flow
Recruitment details
Participants recruited from the Department of Surgery at The Mount Sinai Hospital between November 2012 and October 2014.
Participants by arm
| Arm | Count |
|---|---|
| Transabdominal Plane Block Transabdominal Plane Block with 0.25% bupivacaine | 52 |
| Non Transabdominal Plane Block Non Transabdominal Plane Block: Saline injection | 48 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | converted to open surgery | 1 | 1 |
| Overall Study | did not follow postoperative protocol | 8 | 11 |
| Overall Study | did not inject saline | 0 | 3 |
| Overall Study | medication not available | 2 | 0 |
| Overall Study | no mesh placed | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Transabdominal Plane Block | Non Transabdominal Plane Block |
|---|---|---|---|
| Age, Continuous | 53.22 years STANDARD_DEVIATION 13.11 | 52.67 years STANDARD_DEVIATION 12.89 | 53.81 years STANDARD_DEVIATION 13.45 |
| ASA class 1 | 13 Participants | 7 Participants | 6 Participants |
| ASA class 2 | 48 Participants | 24 Participants | 24 Participants |
| ASA class 3 | 36 Participants | 20 Participants | 16 Participants |
| ASA class 4 | 3 Participants | 1 Participants | 2 Participants |
| BMI | 31.03 kg/m^2 STANDARD_DEVIATION 6.21 | 30.91 kg/m^2 STANDARD_DEVIATION 5.45 | 31.16 kg/m^2 STANDARD_DEVIATION 7 |
| Coronary artery disease | 15 Participants | 6 Participants | 9 Participants |
| Diabetes | 19 Participants | 10 Participants | 9 Participants |
| GERD | 25 Participants | 12 Participants | 13 Participants |
| Hernia defect size | 39.12 cm^2 STANDARD_DEVIATION 51.99 | 38.46 cm^2 STANDARD_DEVIATION 42.26 | 39.84 cm^2 STANDARD_DEVIATION 61.27 |
| Hyperlipidemia | 34 Participants | 14 Participants | 20 Participants |
| Hypertension | 48 Participants | 25 Participants | 23 Participants |
| Location of hernia defect Epigastric | 41 Participants | 23 Participants | 18 Participants |
| Location of hernia defect Infraumbilical | 9 Participants | 2 Participants | 7 Participants |
| Location of hernia defect Lateral | 11 Participants | 8 Participants | 3 Participants |
| Location of hernia defect Umbilical | 39 Participants | 19 Participants | 20 Participants |
| LOS <2 days | 71 Participants | 35 Participants | 36 Participants |
| LOS ≥2 days | 29 Participants | 17 Participants | 12 Participants |
| Previous abdominal surgery | 72 Participants | 41 Participants | 31 Participants |
| Sex: Female, Male Female | 48 Participants | 27 Participants | 21 Participants |
| Sex: Female, Male Male | 52 Participants | 25 Participants | 27 Participants |
| Smoker | 32 Participants | 15 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Post-operative Opioid Use
Amount of opioids used by patients at certain time points.
Time frame: up to 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transabdominal Plane Block | Post-operative Opioid Use | at 24 hours | 25.64 mg | Standard Deviation 0 |
| Transabdominal Plane Block | Post-operative Opioid Use | at 12 hours | 16.09 mg | Standard Deviation 0 |
| Transabdominal Plane Block | Post-operative Opioid Use | at 18 hours | 20.70 mg | Standard Deviation 0 |
| Transabdominal Plane Block | Post-operative Opioid Use | at 6 hours | 10.59 mg | Standard Deviation 0 |
| Non Transabdominal Plane Block | Post-operative Opioid Use | at 24 hours | 42.56 mg | Standard Deviation 0 |
| Non Transabdominal Plane Block | Post-operative Opioid Use | at 6 hours | 15.62 mg | Standard Deviation 0 |
| Non Transabdominal Plane Block | Post-operative Opioid Use | at 18 hours | 39.37 mg | Standard Deviation 0 |
| Non Transabdominal Plane Block | Post-operative Opioid Use | at 12 hours | 32.24 mg | Standard Deviation 0 |
Secondary
Operating Procedure Time
Total number of minutes for the procedure, not including anesthesia time.
Time frame: Procedure begin time to procedure end time
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transabdominal Plane Block | Operating Procedure Time | 97.41 min | Standard Deviation 30.22 |
| Non Transabdominal Plane Block | Operating Procedure Time | 98.81 min | Standard Deviation 37.51 |
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.
Time frame: 1 hour postoperatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transabdominal Plane Block | Pain Score | pain scores at rest | 5.19 units on a scale | Standard Deviation 0.39 |
| Transabdominal Plane Block | Pain Score | pain scores with movement | 6.15 units on a scale | Standard Deviation 0.42 |
| Non Transabdominal Plane Block | Pain Score | pain scores at rest | 6.46 units on a scale | Standard Deviation 0.38 |
| Non Transabdominal Plane Block | Pain Score | pain scores with movement | 7.73 units on a scale | Standard Deviation 0.4 |
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.
Time frame: 24 hours postoperatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transabdominal Plane Block | Pain Score | pain scores at rest | 4.60 units on a scale | Standard Deviation 0.39 |
| Transabdominal Plane Block | Pain Score | pain scores with movement | 6.75 units on a scale | Standard Deviation 0.38 |
| Non Transabdominal Plane Block | Pain Score | pain scores at rest | 4.52 units on a scale | Standard Deviation 0.31 |
| Non Transabdominal Plane Block | Pain Score | pain scores with movement | 6.98 units on a scale | Standard Deviation 0.4 |