Transversus Abdominis Plane Catheter Following Kidney Transplantation

Pain, Postoperative Clinical Trial

Official title:

Transversus Abdominis Plane Catheter Following Kidney Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04786470
• Other study ID #: 116618
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 2021
• Est. completion date: November 2022

Study information

• Verified date: March 2021
• Source: Western University, Canada
• Contact: Andrew C Rasmussen, MD
• Email: arasmuss[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Continuous Infusion of Local Anesthetic After Kidney Transplantation

This is a phase III, randomized, double-blinded, sham-controlled trial comparing the use of a continuous infusion of local anesthetic via transversus abdominis plane (TAP) catheter to a saline infusion (sham) via TAP catheter along with standard postoperative analgesia in patients undergoing kidney transplantation. Patients will have a TAP catheter placed at the time of kidney transplantation by the surgical team under direct vision. They are then randomized to a continuous infusion of local anesthetic or saline for 48 hours postoperatively. Both groups will receive a standard postoperative analgesic regimen including a Patient Controlled Analgesic (PCA) pump and multimodal analgesics including acetaminophen and gabapentin.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Male, female, non-binary gender, aged >18 years.

4. Undergoing a kidney transplant (deceased or living donor) as treatment for stage 5 chronic kidney disease (Glomerular filtration rate < 15ml/min) either on dialysis, or approaching dialysis

5. No history of allergy to any local anesthetic.

6. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration

Exclusion Criteria:

1. Current use of opioid pain medications prior to kidney transplantation.

2. Known allergic reactions to components of any local anesthetic medication.

3. Prior local anesthetic systemic toxicity.

4. History of chronic pain undergoing current active treatment for the same.

5. Age <18 years (this analgesic approach has not been established in this population).

6. Unable or unwilling to use IV PCA pump for any reason (manual dexterity, cognitive impairment, patient choice etc.).

7. Multi-visceral transplantation.

8. Incision other than standard Gibson incision.

9. Unilateral or bilateral nephrectomy at time of kidney transplant.

10. Advanced liver disease.

Related Conditions & MeSH terms

• Kidney Transplant
• Pain, Postoperative

Intervention

Drug:
• Ropivacaine
Ropivacaine infusion via transversus abdominis plane catheter.
• Saline
Saline infusion via transversus abdominis plane catheter.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral morphine equivalent (OME)	OME in mg	48 hours post kidney transplantation
Secondary	Visual Analog Scale pain rating	Series of 5 faces that depict discomfort levels ranging from severe pain (score 5) to no pain at all (score 1). The higher the score, the more pain a patient has.	12, 24, and 48 hours post kidney transplantation
Secondary	Patient quality of life score		48 hours post kidney transplantation
Secondary	Time to return of bowel function postoperatively		Duration of admission
Secondary	Incidence of local anesthetic systemic toxicity		Duration of admission
Secondary	Postoperative adverse events (surgical)		Duration of admission
Secondary	Delayed graft function	Defined as the requirement for hemodialysis/peritoneal dialysis within the first 7 days after kidney transplantation for any reason.	Duration of admission
Secondary	Creatinine (mmol/L) at time of discharge		Duration of admission
Secondary	Length of stay		Duration of admission