Bariatric Surgery, Transverse Abdominal Plane Regional Blocks
Conditions
Brief summary
Addition of transverse abdominis plane (TAP) block to general anesthesia for morbidly obese patients (BMI \>35) undergoing laparoscopic bariatric surgery for weight loss will significantly reduce opioid use in the recovery room
Interventions
PROCEDURETransverse abdominal plane block
Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.
DRUGRopivacaine
Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. The patient must be 18 years of age or older and able to provide his or her own consent. 2. The patient is scheduled for bariatric surgery including laparoscopic gastric banding, sleeve gastrectomy, and gastric bypass. 3. The patient must be surgically and medically accepted for the procedure 4. Good functional status, ability to perform activities of daily living 5. The patients BMI \> 35, no upper limit 6. Signed study specific informed consent prior to enrollment
Exclusion criteria
1. Patients with an allergy to local anesthetics 2. Patients diagnosed with peripheral neuropathies including diabetes mellitus. 3. Patients with BMI \<35 4. Patients with significant coronary artery disease 5. Patient refusal of block procedure. 6. Patients with chronic pain 7. Patients on pre-operative maintenance narcotics 8. American Society of Anesthesiologist classification system 4 (ASA 4) patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Opioid Usage | 24 hour after surgery | The amounts of opioids used by the patient will be collected by a person blinded to the allocation group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score Assessed With Visual Analog Score (VAS) | 30 minutes within arrival to PACU | Visual Analog Score (VAS) scores correlate to Pain scores (0-10, 0 being no pain and 10 being the worst pain). VAS will be taken within 30 minutes of arrival to post anesthesia care unit (PACU) |
| Nausea: The Number of Participants Experiencing Nausea Will be Assessed by Chart Review | Up to 5 hours | The number of participants experiencing nausea will be assessed by chart review |
| Vomiting: The Number of Participants Experiencing Vomiting Will be Assessed by Chart Review | Up to 5 hours | The number of participants experiencing vomiting will be assessed by chart review |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TAP, Bupivacaine This group will receive general anesthesia and at the end of the operation, but still in the operating room, a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.
Transverse abdominal plane block: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.
Ropivacaine: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle. | 12 |
| No Intervention General anesthesia | 11 |
| Total | 23 |
Baseline characteristics
| Characteristic | TAP, Bupivacaine | No Intervention | Total |
|---|---|---|---|
| Age, Continuous | 43.5 years | 43 years | 43.5 years |
| Region of Enrollment United States | 12 participants | 11 participants | 23 participants |
| Sex: Female, Male Female | 11 Participants | 10 Participants | 21 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 11 |
| other Total, other adverse events | 0 / 12 | 0 / 11 |
| serious Total, serious adverse events | 0 / 12 | 0 / 11 |
Outcome results
Primary
Post Operative Opioid Usage
The amounts of opioids used by the patient will be collected by a person blinded to the allocation group
Time frame: 24 hour after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAP, Bupivacaine | Post Operative Opioid Usage | 2.25 morphine equivalent |
| No Intervention | Post Operative Opioid Usage | 4 morphine equivalent |
Secondary
Nausea: The Number of Participants Experiencing Nausea Will be Assessed by Chart Review
The number of participants experiencing nausea will be assessed by chart review
Time frame: Up to 5 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAP, Bupivacaine | Nausea: The Number of Participants Experiencing Nausea Will be Assessed by Chart Review | 5 Participants |
| No Intervention | Nausea: The Number of Participants Experiencing Nausea Will be Assessed by Chart Review | 3 Participants |
Secondary
Pain Score Assessed With Visual Analog Score (VAS)
Visual Analog Score (VAS) scores correlate to Pain scores (0-10, 0 being no pain and 10 being the worst pain). VAS will be taken within 30 minutes of arrival to post anesthesia care unit (PACU)
Time frame: 30 minutes within arrival to PACU
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAP, Bupivacaine | Pain Score Assessed With Visual Analog Score (VAS) | 5.5 units on a scale |
| No Intervention | Pain Score Assessed With Visual Analog Score (VAS) | 2 units on a scale |
Secondary
Vomiting: The Number of Participants Experiencing Vomiting Will be Assessed by Chart Review
The number of participants experiencing vomiting will be assessed by chart review
Time frame: Up to 5 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAP, Bupivacaine | Vomiting: The Number of Participants Experiencing Vomiting Will be Assessed by Chart Review | 0 Participants |
| No Intervention | Vomiting: The Number of Participants Experiencing Vomiting Will be Assessed by Chart Review | 2 Participants |