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

ConditionsTransplant;Failure,KidneyPain, Postoperative
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Davis

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients ages 18 years or older

Renal Transplant Recipients

Disqualifiers

Patients less than 18 years of age

Pregnant Women

Prisoners

Opioid Tolerant Patients taking more than 30 mg/day of oral morphine equivalent analgesia

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ropivacaine Continuous Infusion Catheter

    Drug

    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.

  • Single Dose Liposomal Bupivicaine

    Drug

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Ropivacaine Continuous Infusion CatheterActive comparator 1 intervention
Group B: Single dose liposomal bupivicaineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Through 4 days following renal transplant surgery

Secondary outcomes

1

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)

Time frame
Through 4 days following renal transplant surgery
2

Post Operative Nausea

Count of post operative nausea episodes

Time frame
Through 4 days following renal transplant surgery
3

Post Operative Vomiting

Count of post operative vomiting events

Time frame
Through 4 days following renal transplant
4

Respiratory Depression

Count of Respiratory Depression events defined as respiratory rate less than 8 breaths per minute

Time frame
Through 4 days following renal transplant surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Davis

Lead sponsor

Source ClinicalTrials.gov
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