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NCT06011421 Clinical Trial

Wound Catheter Vs LA Bolus in Renal Transplant: RCT

Wound Clinical Trial

Official title:
Wound Catheter Vs LA Bolus in Renal Transplant: RCT

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06011421
Other study ID # GS21/138922
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 31, 2022
Est. completion date November 1, 2023

Study information
Verified date August 2023
Source The Leeds Teaching Hospitals NHS Trust
Contact Sonsoles Martinez-Lopez
Phone 0113 243 3144
Email sonsoles.martinez-lopez@nhs.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 88
Est. completion date November 1, 2023
Est. primary completion date November 1, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Local Anaesthetic Wound Catheter Insertion
Use of the Local Anaesthetic Wound Catheter Insertion during kidney transplant

Locations
Country Name City State
United Kingdom Leeds Teaching Hospital NHS Trust Leeds
United Kingdom Leeds Teaching Hospitals NHS Trust Leeds

Sponsors (1)
Lead Sponsor Collaborator
The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Total Dose of IV Morphine in the first 24 hours post op Measurment of the dose delivered in 24 hours 24 hours
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