Wound Catheter Vs LA Bolus in Renal Transplant: RCT

NCT ID: NCT06011421

Last Updated: 2023-08-25

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

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-31

Study Completion Date

2023-11-01

Brief Summary

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Pain control is an important part of patients' care after a kidney transplant. Currently patients receive a one off injection of Local Anaesthetic (LA) in the wound at the end of the operation followed by Intravenous morphine through a Patient Controlled Analgesia System (PCAS), a button pressed to provide a calculated dose with lock out times for safety.

Through this study the aim to test the efficiency of Continuous Local Anaesthetic Infiltration via Wound Catheter (LAWC) which is a method to deliver Local Anaesthetic over a longer period of time after the operation. LAWC are currently in use in a variety of surgical specialities including Liver surgery. Patients participating in this study will be allocated randomly to one of 2 groupsÍž one will receive LA at the end of the operation as per current practice and one will receive LAWC. It then compare outcomes such as the the dose of morphine required in the PCAS, quality of pain control and improvement in recovery.

Detailed Description

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Conditions

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Wound

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Local Anaesthetic Wound Catheter Insertion

Use of the Local Anaesthetic Wound Catheter Insertion during kidney transplant

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Primary kidney transplantation
* Single kidney transplantation
* Signed informed Consent

Exclusion Criteria

* Midline laparotomy
* Dual kidney transplantation
* Kidney re-transplantation
* Multi-organ transplantation
* Patients on Long term opiates
* Patients with psychiatric illness
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Leeds Teaching Hospital NHS Trust

Leeds, , United Kingdom

Site Status RECRUITING

Leeds Teaching Hospitals NHS Trust

Leeds, , United Kingdom

Site Status COMPLETED

Countries

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United Kingdom

Central Contacts

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Sonsoles Martinez-Lopez

Role: CONTACT

0113 243 3144

Facility Contacts

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Sonsoles Martinez-Lopez, MD FEBS

Role: primary

Other Identifiers

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GS21/138922

Identifier Type: -

Identifier Source: org_study_id

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