New Approach of Loco Regional Analgesia in Kidney Transplant

NCT05391451 | Completed

• 1 other identifier: PO21061
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Kidney transplant is considered as a moderate painful surgery. Unfortunately, patients with chronic kidney disease are not able to degrade opioid drugs and are therefore most likely to be subjected to the secondary effects of their consumption. Current strategies aim to find pain relief substitutes in order to decrease the use of opioids, specially after surgery, during patient recovery. Loco-regional analgesia consists of administering local anesthesic directly in specific nerves and is being used in several surgical procedures. In various abdominal surgeries, a loco-regional analgesia called "tranversus abdominis Plane Block" has been associated with decreased morphine consumption and better post-operative conditions. In kidney transplant, the definitive efficacy of this loco-regional analgesia is not established, due to controversial clinical results. The goal of our study is to test the analgesia advantage of a variant of the Tranversus Abdominis Plane Block, called Quadratus lumborum block, which targets a muscle called quadratus lumborum, in association with general anesthesia, on post-surgery recovery and opioid intake.

Conditions

Chronic Kidney Diseases

Keywords

Analgesia; Chronic kidney disease; Renal Transplant

Outcome Measures

Primary Outcomes (1)

• consumption of morphine

  Total consumption of morphine during the first day after surgery

  Day 1

Secondary Outcomes (5)

• consumption of ULTIVA

  Day 0

• Pain evaluation

  Hour 1

• Pain evaluation

  Hour 2

• Pain evaluation

  Hour 6

• Pain evaluation

  Hour 12

Study Arms (2)

Quadratus lumborum block (QLB) group

EXPERIMENTAL

Procedure: efficacy of quadratus lumborum block in post-operative analgesia in kidney transplant surgery

Control group

ACTIVE COMPARATOR

Procedure: general anesthesia

Interventions

efficacy of quadratus lumborum block in post-operative analgesia in kidney transplant surgery PROCEDURE

no premedication for anxiolytic purposes before surgery. Cimetidin 200mg can be administrated for Mendelson syndrome prevention. After general anesthesia induction, echo-guided quadratus lumborum block is performed by applying 20ml of levobupivacaine

Quadratus lumborum block (QLB) group

general anesthesia PROCEDURE

general anesthesia is the current technique for kidney transplant surgery. The protocol involves the combination of several drugs: Propofol, Remifentanil, Ketamin, Atracurium or Cisatracurium. Curarization monitoring is systematic.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients eligible for kidney transplant surgery at the CHU de Reims
• Patients agreeing to participate in the research and having signed the informed consent
• Adult patients
• Patients affiliated to a social security scheme

You may not qualify if:

• Legally protected
• Known allergy to local anesthetics used
• Manifest polyneuropathy
• ASA score \> 4
• Pregnancy, breastfeeding
• Contraindications to QLB
• Technique refusal
• Previous kidney transplant
• History of major abdominal surgery

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Agnosia

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 26, 2022
• Study Start: August 31, 2021
• Primary Completion: September 23, 2022
• Study Completion: October 23, 2022
• Last Updated: November 29, 2024

Record last verified: 2024-11

Locations

FR (1)