Colorectal Surgery, TAP Blocks
Conditions
Brief summary
This is a prospective randomized study designed to compare the pain control from a single shot of liposomal bupivacaine (Exparel) against transversus abominus plane (TAP) catheters with ropivicaine bolus in patients undergoing elective colorectal surgery.
Detailed description
At UC Davis, it is standard practice to place TAP blocks with catheters for adult colorectal surgery patients for perioperative pain control. This practice, however, is resource intensive, adds the risk of catheter-related complications, and adds increased burden to patients by requiring them to be tethered to 2 catheters. An alternative TAP can be performed using a single shot of liposomal bupivacaine (Exparel), an extended release local anesthetic that is FDA-approved for surgical plane infiltration including TAP blocks. With this prospective study, we seek to improve patient care at UC Davis and educate other institutions through the use of concrete data comparing these 2 treatment options.
Interventions
DRUGExparel
Patients will receive an injection of 30ml of volume to each abdominal side with a total of 60 ml for bilateral TAP blocks.
DRUGRopivacaine
Patients will receive 30ml of ropivicaine. Peripheral nerve catheters will be placed approximately 3-5cm into the TAP space and secured to the skin with tegaderm tape. Infusions will be ordered with CADD pumps and will be initiated at a rate of 8ml/hr of 0.2% ropivicaine on the inpatient floor.
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for elective colorectal surgery with Dr. Linda Farkas
Exclusion criteria
* Patients under 18 years of age * Patient over 90 years of age * Pregnancy * Prisoners * Patients unable to provide consent * Patients on systemic anticoagulation therapy * Patients with an allergy to local anesthetics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Opioid Consumption in Morphine Opioid Equivalents in mg | 48 hours from start of surgery | Anticipate superior efficacy and pain control with liposomal bupivacaine TAP blocks measured by use of opioids (measured in oral morphine equivalents) in the first 48 hours following surgery Will use opioid consumption in morphine equivalents as a comparison |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Single injection of Exparel
Exparel: Patients will receive an injection of 30ml of volume to each abdominal side with a total of 60 ml for bilateral TAP blocks. | 42 |
| Group 2 Injection of Ropivicaine (Naropin) bolus and placement of Ropivicaine catheters
Ropivacaine: Patients will receive 30ml of ropivicaine. Peripheral nerve catheters will be placed approximately 3-5cm into the TAP space and secured to the skin with tegaderm tape. Infusions will be ordered with CADD pumps and will be initiated at a rate of 8ml/hr of 0.2% ropivicaine on the inpatient floor. | 44 |
| Total | 86 |
Baseline characteristics
| Characteristic | Group 2 | Total | Group 1 |
|---|---|---|---|
| Age, Continuous | 57.1 years | 57.2 years | 57.4 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 44 participants | 86 participants | 42 participants |
| Sex: Female, Male Female | 24 Participants | 45 Participants | 21 Participants |
| Sex: Female, Male Male | 20 Participants | 41 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 44 |
| other Total, other adverse events | 0 / 42 | 0 / 44 |
| serious Total, serious adverse events | 0 / 42 | 0 / 44 |
Outcome results
Primary
Mean Opioid Consumption in Morphine Opioid Equivalents in mg
Anticipate superior efficacy and pain control with liposomal bupivacaine TAP blocks measured by use of opioids (measured in oral morphine equivalents) in the first 48 hours following surgery Will use opioid consumption in morphine equivalents as a comparison
Time frame: 48 hours from start of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Mean Opioid Consumption in Morphine Opioid Equivalents in mg | 112.12 IV morphine equivalents (mg) | Standard Deviation 112.8 |
| Group 2 | Mean Opioid Consumption in Morphine Opioid Equivalents in mg | 97.95 IV morphine equivalents (mg) | Standard Deviation 58.15 |