TAP Blocks With Ropivacaine Continuous Infusion Catheters vs Single Dose Liposomal Bupivicaine After Kidney Transplant

Study Overview
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Brief Summary
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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
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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.

Official Title
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Transversus Abdominis Plane (TAP) Blocks With Ropivacaine Continuous Infusion Catheters vs Single Dose Liposomal Bupivicaine: A Prospective Randomized Control Trial for Pain Control After Renal Transplant Surgery

Conditions
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Pain, Postoperative, Transplant;Failure,Kidney

Intervention / Treatment
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* Drug: Ropivacaine Continuous Infusion Catheter
* Drug: Single Dose Liposomal Bupivicaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ropivacaine Continuous Infusion Catheter<br>Ropivacaine Continuous Infusion Catheter: ultrasound guided TAP block and TAP catheter placement performed with 0.2% ropivacaine (2.5 mg/kg) and maintained with 0.2% ropivacaine infusion 8 ml/hour via catheter. | Drug: Ropivacaine Continuous Infusion Catheter<br>* 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.<br>* Other names: TAP block initiated with ropivacaine bolus and infusion;|
| Active Comparator: Single dose liposomal bupivicaine<br>Liposomal bupivacaine TAP block: ultrasound guided TAP block a performed with up to 12 ml 0.25% bupivacaine and prolonged with liposomal bupivacaine 133 mg diluted to total volume of 20 ml with preservative free saline. | Drug: Single Dose Liposomal Bupivicaine<br>* 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.<br>* Other names: TAP block with liposomal bupivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Total Opioid Consumption | Total amount of opioid analgesic administered following renal transplant surgery converted using standard equivalency calculations to morphine equivalents mg/kg | Through 4 days following renal transplant surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of pain scores indicating severe pain | 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) | Through 4 days following renal transplant surgery | 
| Post Operative Nausea | Count of post operative nausea episodes | Through 4 days following renal transplant surgery | 
| Post Operative Vomiting | Count of post operative vomiting events | Through 4 days following renal transplant | 
| Respiratory Depression | Count of Respiratory Depression events defined as respiratory rate less than 8 breaths per minute | Through 4 days following renal transplant surgery | 
| Post Operative Care Unit and Hospital Length of Stay | Length of Stay | Up to 2 weeks following renal transplant surgery | 
| Acquisition Costs Related to Analgesia | 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 | Up to 2 weeks following renal transplant surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transversus Abdominis Plane Block, Ropivacaine, Liposomal bupivacaine