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

Primary Purpose

Transplant;Failure,Kidney, Pain, Postoperative

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine Continuous Infusion Catheter
Single Dose Liposomal Bupivicaine
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transplant;Failure,Kidney focused on measuring Transversus Abdominis Plane Block, Ropivacaine, Liposomal bupivacaine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California DavisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ropivacaine Continuous Infusion Catheter

Single dose liposomal bupivicaine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
Post Operative Nausea
Count of post operative nausea episodes
Post Operative Vomiting
Count of post operative vomiting events
Respiratory Depression
Count of Respiratory Depression events defined as respiratory rate less than 8 breaths per minute
Post Operative Care Unit and Hospital Length of Stay
Length of Stay
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

Full Information

First Posted
October 9, 2018
Last Updated
June 6, 2023
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT03737604
Brief Title
TAP Blocks With Ropivacaine Continuous Infusion Catheters vs Single Dose Liposomal Bupivicaine After Kidney Transplant
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2018 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transplant;Failure,Kidney, Pain, Postoperative
Keywords
Transversus Abdominis Plane Block, Ropivacaine, Liposomal bupivacaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Unable to mask based on physical characteristics of liposomal bupivacaine
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine Continuous Infusion Catheter
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Single dose liposomal bupivicaine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine Continuous Infusion Catheter
Other Intervention Name(s)
TAP block initiated with ropivacaine bolus and infusion
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Single Dose Liposomal Bupivicaine
Other Intervention Name(s)
TAP block with liposomal bupivacaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in Total Opioid Consumption
Description
Total amount of opioid analgesic administered following renal transplant surgery converted using standard equivalency calculations to morphine equivalents mg/kg
Time Frame
Through 4 days following renal transplant surgery
Secondary Outcome Measure Information:
Title
Proportion of pain scores indicating severe pain
Description
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)
Time Frame
Through 4 days following renal transplant surgery
Title
Post Operative Nausea
Description
Count of post operative nausea episodes
Time Frame
Through 4 days following renal transplant surgery
Title
Post Operative Vomiting
Description
Count of post operative vomiting events
Time Frame
Through 4 days following renal transplant
Title
Respiratory Depression
Description
Count of Respiratory Depression events defined as respiratory rate less than 8 breaths per minute
Time Frame
Through 4 days following renal transplant surgery
Title
Post Operative Care Unit and Hospital Length of Stay
Description
Length of Stay
Time Frame
Up to 2 weeks following renal transplant surgery
Title
Acquisition Costs Related to Analgesia
Description
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
Time Frame
Up to 2 weeks following renal transplant surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Arias, BS
Phone
916-703-5456
Email
apaarias@ucdavis.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Natasha Piniero, BS
Phone
916-734-5171
Email
nspiniero@ucdavis.edu
Facility Information:
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Arias, BS
Phone
916-703-5456
Email
apaarias@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Natasha Piniero, BS
Phone
916-734-5171
Email
nspiniero@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Richard Applegate, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://studypages.com/s/a-study-of-the-experimental-medicine-ropivacaine-for-pain-control-after-kidney-transplant-995191/
Description
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TAP Blocks With Ropivacaine Continuous Infusion Catheters vs Single Dose Liposomal Bupivicaine After Kidney Transplant

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