TAP Blocks vs. IV Lidocaine for Kidney Transplants

• ClinicalTrials.gov Identifier: NCT03843879
• Recruitment Status: Unknown
• First Posted: February 18, 2019
• Last Update Posted: July 17, 2019
• Sponsor: Benaroya Research Institute
• Information provided by (Responsible Party): Neil Hanson, Benaroya Research Institute

Tracking Information

• First Submitted Date: February 14, 2019
• First Posted Date: February 18, 2019
• Last Update Posted Date: July 17, 2019
• Actual Study Start Date: April 1, 2019
• Estimated Primary Completion Date: March 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 15, 2019)

Opioid Consumption [ Time Frame: 0-24 Hours ]

Total opioid utilization

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 15, 2019)

• Pain Scores [ Time Frame: 0-48 Hours ]
  Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)
• Opioid Consumption [ Time Frame: 24-48 Hours ]
  Total opioid utilization
• Opioid-Related Adverse Events [ Time Frame: 0-48 Hours ]
  Nausea, Vomiting, Pruritis, Respiratory Depression, Constipation
• Block/Infusion-Related Adverse Events [ Time Frame: 0-48 Hours ]
  Local Anesthetic Systemic Toxicity
• Opioid Usage [ Time Frame: 30 days from discharge ]
  Use of prescribed opioids

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: TAP Blocks vs. IV Lidocaine for Kidney Transplants
• Official Title: A Comparison of Transversus Abdominis Plane Blocks Versus Continuous Intravenous Lidocaine for Kidney Transplant Surgery
• Brief Summary: This study will compare continuous intravenous lidocaine against single-injection transversus abdominis plane (TAP) block as a modality for postoperative analgesia in kidney transplant surgery.
• Detailed Description: This study is a non-inferiority trial designed to assess the analgesic efficacy of an intravenous (IV) lidocaine infusion against single-injection transversus abdominis plane (TAP) block in patients undergoing kidney transplant surgery. The investigators propose a study of 124 subjects randomized into two groups. The control group will receive a TAP block. The study group will receive a continuous IV lidocaine infusion. The investigators hypothesize that there will be no statistically significant difference in postoperative opioid consumption between the two groups in the first 24 hours.
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Postoperative Pain

Intervention

• Procedure: Transversus Abdominis Plane Block
  Single-injection transversus abdominis plane block with 30 mL of 0.25% Bupivacaine with 1:400,000 epinephrine
  Other Name: TAP Block
• Drug: Intravenous Lidocaine
  Continuous intravenous lidocaine infusion
  Other Name: Continuous intravenous lidocaine

Study Arms

• Active Comparator: TAP Block
  Single-injection transversus abdominis plane block
  Intervention: Procedure: Transversus Abdominis Plane Block
• Active Comparator: IV Lidocaine
  Continuous intravenous lidocaine infusion
  Intervention: Drug: Intravenous Lidocaine

• Publications *: Hanson NA, Strunk J, Saunders G, Cowan NG, Brandenberger J, Kuhr CS, Oryhan C, Warren DT, Slee AE, Strodtbeck W. Comparison of continuous intravenous lidocaine versus transversus abdominis plane block for kidney transplant surgery: a randomized, non-inferiority trial. Reg Anesth Pain Med. 2021 Nov;46(11):955-959. doi: 10.1136/rapm-2021-102973. Epub 2021 Aug 20.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 15, 2019): 124
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 1, 2021
• Estimated Primary Completion Date: March 1, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Kidney transplant recipient
• >18 years old
• Consent to participate

Exclusion Criteria:

• <18 years old
• Refusal to participate
• Chronic opioid use
• Seizure disorder
• Allergy to local anesthestics
• Severe hepatic disease

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03843879
• Other Study ID Numbers: IRB18-109
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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.: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Neil Hanson, Benaroya Research Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Benaroya Research Institute
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Neil A Hanson, MD; Virginia Mason Medical Center

• PRS Account: Benaroya Research Institute
• Verification Date: July 2019