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NCT Number: NCT03737604

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Transplant;Failure,Kidney Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California Davis

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: TAP block initiated with ropivacaine bolus and infusion

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.

Other names: TAP block with liposomal bupivacaine

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Nov 9, 2018
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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