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

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ClinicalTrials.gov Identifier: NCT03737604
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Transplant;Failure,Kidney Pain, Postoperative Drug: Ropivacaine Continuous Infusion Catheter Drug: Single Dose Liposomal Bupivicaine Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Unable to mask based on physical characteristics of liposomal bupivacaine
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : October 4, 2019
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ropivacaine Continuous Infusion Catheter
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
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.
Other Name: TAP block initiated with ropivacaine bolus and infusion

Active Comparator: Single dose liposomal bupivicaine
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
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.
Other Name: TAP block with liposomal bupivacaine




Primary Outcome Measures :
  1. Difference in Total Opioid Consumption [ Time Frame: 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 Outcome Measures :
  1. Proportion of pain scores indicating severe pain [ Time Frame: 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)

  2. Post Operative Nausea [ Time Frame: Through 4 days following renal transplant surgery ]
    Count of post operative nausea episodes

  3. Post Operative Vomiting [ Time Frame: Through 4 days following renal transplant ]
    Count of post operative vomiting events

  4. Respiratory Depression [ Time Frame: Through 4 days following renal transplant surgery ]
    Count of Respiratory Depression events defined as respiratory rate less than 8 breaths per minute

  5. Post Operative Care Unit and Hospital Length of Stay [ Time Frame: Up to 2 weeks following renal transplant surgery ]
    Length of Stay

  6. Acquisition Costs Related to Analgesia [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03737604


Contacts
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Contact: Ana Arias, BS 916-703-5456 apaarias@ucdavis.edu
Contact: Natasha Piniero, BS 916-734-5171 nspiniero@ucdavis.edu

Locations
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United States, California
University of California Davis Recruiting
Sacramento, California, United States, 95817
Contact: Ana Arias, BS    916-703-5456    apaarias@ucdavis.edu   
Contact: Natasha Piniero, BS    916-734-5171    nspiniero@ucdavis.edu   
Principal Investigator: Richard Applegate, MD         
Sponsors and Collaborators
University of California, Davis

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03737604     History of Changes
Other Study ID Numbers: 1205738
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of California, Davis:
Transversus Abdominis Plane Block
Ropivacaine
Liposomal bupivacaine
Additional relevant MeSH terms:
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Renal Insufficiency
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Kidney Diseases
Urologic Diseases
Bupivacaine
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents