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CompletedNCT05391451CARRENALUpdated Nov 29, 2024

New Approach of Loco Regional Analgesia in Kidney Transplant

An interventional study of efficacy of quadratus lumborum block in post-operative analgesia in kidney transplant surgery and general anesthesia in Chronic Kidney Diseases, sponsored by CHU de Reims. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-29.

Sponsored by CHU de Reims · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Aug 2021, registered May 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Chronic Kidney Diseases

Keywords

  • Analgesia
  • Chronic kidney disease
  • Renal Transplant
03

In context

Renal Insufficiency, Chronic

3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.

This study's enrollment of 48 is below the median of 74 across 2,229 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

CHU de Reims is the lead sponsor of 275 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Quadratus lumborum block (QLB) group

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

  • Active comparator
    Control group

    Procedure: general anesthesia

Interventions

  • Procedureefficacy 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

  • Proceduregeneral 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.

06

What researchers measure

Primary outcomes

  1. consumption of morphine

    Total consumption of morphine during the first day after surgery

    Time frame: Day 1

Secondary outcomes

  1. consumption of ULTIVA

    Total consumption of ULTIVA during the surgery

    Time frame: Day 0

  2. Pain evaluation

    Pain evaluation at various timepoints by Visual Analog Scale

    Time frame: Hour 1

  3. Pain evaluation

    Pain evaluation at various timepoints by Visual Analog Scale

    Time frame: Hour 2

  4. Pain evaluation

    Pain evaluation at various timepoints by Visual Analog Scale

    Time frame: Hour 6

  5. Pain evaluation

    Pain evaluation at various timepoints by Visual Analog Scale

    Time frame: Hour 12

07

Study locations

1 site
  • Damien JOLLY
    Reims, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2021 to primary completion in Sep 2022, 12 months.

Of 579 non-industry interventional studies with no phase under Renal Insufficiency, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 44. This study's 12 months is below that.

Counting every sponsor, half of 617 studies reached it within 23 months; a quarter within 10 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
May 19, 2022
First posted
May 26, 2022
StartActual
Aug 31, 2021
Primary completionActual
Sep 23, 2022
CompletionActual
Oct 23, 2022
Last update
Nov 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05391451
Lead sponsor
CHU de Reims
Responsible party
Sponsor
First posted
May 26, 2022
Start date
Aug 31, 2021
Primary completion
Sep 23, 2022
Completion
Oct 23, 2022
Last update
Nov 29, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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