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New Approach of Loco Regional Analgesia in Kidney Transplant

NCT ID: NCT05391451

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-31

Study Completion Date

2022-10-23

Brief Summary

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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.

Detailed Description

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Post-operative pain after a kidney transplant can be moderate to severe, but analgesic options are limited. Clearance of the active metabolite of morphin is low in patients with chronic kidney disease, which imposes a strict monitoring of morphin administration. Therefore pain control is difficult and non-optimal.

Reducing both pain and opioid consumption during the per and post operative periods constitutes a major stake, and involves the use of locoregional anesthesia techniques.

The recent literature recommends the realization of a transversus abdominal plane block, despite contradictory results concerning the expected effect.

Even though peridural analgesia remains the gold standard in many types of surgeries, it is not recommended in case of renal transplant due to multiple secondary effects.

The quadratus lumborum bloc echoguid is a recent technique of locoregional analgesia, used in lower abdominal surgeries (appendicectomy, césarian, digestive resection, …) "because of a prolonged duration of action and a sensitive anesthesia spreading" (which provides a much wider field of analgesia?). This technique is not described for the kidney transplant surgery.

This type of bloc will be realized after the induction of general anesthesia. The patient will be positioned in dorsal decubitus with a lumbar block or in left lateral decubitus to expose the iliac fossa and the right flan. After echographia landmark, a solution of local anesthesic will be place in contact of the quadratus lumborum muscle, into the median beam, to obtain a crescent moon image, sign of the good spreading of the local anesthesic.

Conditions

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Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Quadratus lumborum block (QLB) group

Group Type EXPERIMENTAL

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

Intervention Type 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

Control group

Group Type ACTIVE_COMPARATOR

general anesthesia

Intervention Type 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.

Interventions

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general anesthesia

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.

Intervention Type PROCEDURE

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

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHU de Reims

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Damien JOLLY

Reims, , France

Site Status

Countries

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France

Other Identifiers

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PO21061

Identifier Type: -

Identifier Source: org_study_id