Wound Catheter Vs LA Bolus in Renal Transplant: RCT

• Sponsor: The Leeds Teaching Hospitals NHS Trust (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06011421
• Collaborator: (none)
• Enrollment: 88
• Locations: 2
• Anticipated Duration (Months): 21
• Patients Per Site: 44
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Wound	Device: Local Anaesthetic Wound Catheter Insertion

Study Design

• Study Type: Observational
• Anticipated Enrollment: 88 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Wound Catheter Vs LA Bolus in Renal Transplant: RCT
• Actual Study Start Date: Jan 31, 2022
• Anticipated Primary Completion Date: Nov 1, 2023
• Anticipated Study Completion Date: Nov 1, 2023

Outcome Measures

Primary Outcome Measures

1. Total Dose of IV Morphine in the first 24 hours post op [24 hours]

   Measurment of the dose delivered in 24 hours

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Leeds Teaching Hospital NHS Trust	Leeds		United Kingdom	LS7 4SA
2	Leeds Teaching Hospitals NHS Trust	Leeds		United Kingdom

Sponsors and Collaborators

• The Leeds Teaching Hospitals NHS Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Leeds Teaching Hospitals NHS Trust
• ClinicalTrials.gov Identifier: NCT06011421
• Other Study ID Numbers: GS21/138922
• First Posted: Aug 25, 2023
• Last Update Posted: Aug 25, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Wounds and Injuries; Anesthetics; Anesthetics, Local

Study Results

No Results Posted as of Aug 25, 2023