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OpenTrials
Completed

NCT Number: NCT05391451

New Approach of Loco Regional Analgesia in Kidney Transplant

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. consumption of morphine

    Time frame: Day 1

    Total consumption of morphine during the first day after surgery

Secondary outcomes

  1. consumption of ULTIVA

    Time frame: Day 0

    Total consumption of ULTIVA during the surgery

  2. Pain evaluation

    Time frame: Hour 1

    Pain evaluation at various timepoints by Visual Analog Scale

  3. Pain evaluation

    Time frame: Hour 2

    Pain evaluation at various timepoints by Visual Analog Scale

  4. Pain evaluation

    Time frame: Hour 6

    Pain evaluation at various timepoints by Visual Analog Scale

  5. Pain evaluation

    Time frame: Hour 12

    Pain evaluation at various timepoints by Visual Analog Scale

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study title

Clinical Efficacy of the Quadratus Lumborum Block for Analgesia in Kidney Transplant Surgery

Acronym: CARRENAL

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 26, 2022
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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