Pain, Postoperative, Transplant;Failure,Kidney
Conditions
Keywords
Transversus Abdominis Plane Block, Ropivacaine, Liposomal bupivacaine
Brief summary
This study is a comparison of the analgesic efficacy of transversus abdominis plane (TAP) blocks with ropivacaine bolus plus continuous ropivacaine infusion via catheters versus single shot TAP blocks with liposomal bupivacaine.
Detailed description
This study is a comparison of the analgesic efficacy of TAP blocks provided by ropivacaine bolus plus continuous ropivacaine infusion via catheters versus single shot TAP blocks with liposomal bupivacaine. In the Liposomal Bupivacaine group, TAP block will be performed using ultrasound guidance. 12ml of 0,25% plain bupivacaine will be used for skin infiltration and to open up the TAP. Liposomal Bupivacaine 266 mg (1.3% in 20 ml) will be diluted to 40 ml volume with 20 ml of preservative free normal saline. 20 ml (133mg) of liposomal bupivicaine will then be injected into the TAP. For those randomized to the TAP catheter group, ultrasound guidance will be used for TAP block and 5 mls 1% lidocaine will be used for skin infiltration. A peripheral nerve catheter will be placed approximately 3-5 cm into the TAP space after injection of ropivacaine. A bolus dose of 2.5 mg/kg of ropivacaine will be administered in a volume of 30 ml up to a maximum of 150 mg. An infusion with a programmable pump will be initiated at a rate of 8 ml/hr of 0.2% ropivacaine on the inpatient floor.
Interventions
DRUGRopivacaine Continuous Infusion Catheter
For those randomized to the TAP catheter group, ultrasound guidance will be used for TAP block and 5mls 1% lidocaine will be used for skin infiltration. A peripheral nerve catheter will be placed approximately 3-5 cm into the TAP space after injection of the ropivacaine solution. A bolus dose of 2.5 mg/kg of ropivacaine will be administered in a volume of 30 ml up to a maximum of 150 mg. An infusion with a programmable pump will be initiated at a rate of 8 ml/hr of 0.2% ropivacaine on the inpatient floor.
DRUGSingle Dose Liposomal Bupivicaine
TAP block will be performed using ultrasound guidance. 12ml of 0,25% plain bupivacaine will be used for skin infiltration and to open up the TAP. Liposomal bupivacaine 266 mg (1.3% in 20 ml) will be diluted to 40 ml volume with 20 ml of preservative free normal saline. 20 ml (133mg) of liposomal bupivicaine will then be injected into the TAP.
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Unable to mask based on physical characteristics of liposomal bupivacaine
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients ages 18 years or older * Renal Transplant Recipients
Exclusion criteria
* Patients less than 18 years of age * Pregnant Women * Prisoners * Opioid Tolerant Patients taking more than 30 mg/day of oral morphine equivalent analgesia * Patients on Systemic anti coagulation * Patients unable to provide consent * Hypersensitivity to amide-type local anesthetic or any component of the drug formula
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Total Opioid Consumption | Through 4 days following renal transplant surgery | Total amount of opioid analgesic administered following renal transplant surgery converted using standard equivalency calculations to morphine equivalents mg/kg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of pain scores indicating severe pain | Through 4 days following renal transplant surgery | Proportion of pain scores 7 or higher indicating severe pain as determined by patient report of pain using verbal pain score from 0 (no pain) to10 (most severe pain) |
| Post Operative Nausea | Through 4 days following renal transplant surgery | Count of post operative nausea episodes |
| Post Operative Vomiting | Through 4 days following renal transplant | Count of post operative vomiting events |
| Respiratory Depression | Through 4 days following renal transplant surgery | Count of Respiratory Depression events defined as respiratory rate less than 8 breaths per minute |
| Post Operative Care Unit and Hospital Length of Stay | Up to 2 weeks following renal transplant surgery | Length of Stay |
| Acquisition Costs Related to Analgesia | Up to 2 weeks following renal transplant surgery | Analgesia Related Costs defined as the sum of hospital specific costs to acquire medications and supplies needed to perform block or administer analgesic and local anesthetic medications |
Countries
United States
Outcome results
None listed