NCT06011421

Brief 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 groups; 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

1.8 years

First QC Date

August 21, 2023

Last Update Submit

August 21, 2023

Conditions

Wound

Outcome Measures

Primary Outcomes (1)

  • Total Dose of IV Morphine in the first 24 hours post op

    Measurment of the dose delivered in 24 hours

    24 hours

Interventions

Local Anaesthetic Wound Catheter InsertionDEVICE

Use of the Local Anaesthetic Wound Catheter Insertion during kidney transplant

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing kidney transplant

You may qualify if:

  • Primary kidney transplantation
  • Single kidney transplantation
  • Signed informed Consent

You may not qualify if:

  • Midline laparotomy
  • Dual kidney transplantation
  • Kidney re-transplantation
  • Multi-organ transplantation
  • Patients on Long term opiates
  • Patients with psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Leeds Teaching Hospital NHS Trust

Leeds, LS7 4SA, United Kingdom

RECRUITING

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

COMPLETED

MeSH Terms

Conditions

Wounds and Injuries

Central Study Contacts

Sonsoles Martinez-Lopez

CONTACT

0113 243 3144sonsoles.martinez-lopez@nhs.net

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2023

First Posted

August 25, 2023

Study Start

January 31, 2022

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

August 25, 2023

Record last verified: 2023-08

Locations

GB(2)