TAP Blocks vs. IV Lidocaine for Kidney Transplants

NCT ID: NCT03843879

Last Updated: 2019-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2021-09-01

Brief Summary

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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

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TAP Block

Single-injection transversus abdominis plane block

Group Type ACTIVE_COMPARATOR

Transversus Abdominis Plane Block

Intervention Type PROCEDURE

Single-injection transversus abdominis plane block with 30 mL of 0.25% Bupivacaine with 1:400,000 epinephrine

IV Lidocaine

Continuous intravenous lidocaine infusion

Group Type ACTIVE_COMPARATOR

Intravenous Lidocaine

Intervention Type DRUG

Continuous intravenous lidocaine infusion

Interventions

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Transversus Abdominis Plane Block

Single-injection transversus abdominis plane block with 30 mL of 0.25% Bupivacaine with 1:400,000 epinephrine

Intervention Type PROCEDURE

Intravenous Lidocaine

Continuous intravenous lidocaine infusion

Intervention Type DRUG

Other Intervention Names

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TAP Block Continuous intravenous lidocaine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Benaroya Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Neil Hanson

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Neil A Hanson, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Mason Medical Center

Locations

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Virginia Mason Medical Center

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Neil A Hanson, MD

Role: CONTACT

206-223-6980

Wyndam M Strodtbeck, MD

Role: CONTACT

206-223-6980

Facility Contacts

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Neil A Hanson, MD

Role: primary

Wyndam M Strodtbeck, MD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 34417343 (View on PubMed)

Other Identifiers

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IRB18-109

Identifier Type: -

Identifier Source: org_study_id

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