New Approach of Loco Regional Analgesia in Kidney Transplant (CARRENAL)
Primary Purpose
Chronic Kidney Diseases
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
efficacy of quadratus lumborum block in post-operative analgesia in kidney transplant surgery
general anesthesia
Sponsored by
About this trial
This is an interventional other trial for Chronic Kidney Diseases focused on measuring Analgesia, Chronic kidney disease, Renal Transplant
Eligibility Criteria
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
Sites / Locations
- Damien JOLLYRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Quadratus lumborum block (QLB) group
Control group
Arm Description
Outcomes
Primary Outcome Measures
consumption of morphine
Total consumption of morphine during the first day after surgery
Secondary Outcome Measures
consumption of ULTIVA
Total consumption of ULTIVA during the surgery
Pain evaluation
Pain evaluation at various timepoints by Visual Analog Scale
Pain evaluation
Pain evaluation at various timepoints by Visual Analog Scale
Pain evaluation
Pain evaluation at various timepoints by Visual Analog Scale
Pain evaluation
Pain evaluation at various timepoints by Visual Analog Scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05391451
Brief Title
New Approach of Loco Regional Analgesia in Kidney Transplant
Acronym
CARRENAL
Official Title
Clinical Efficacy of the Quadratus Lumborum Block for Analgesia in Kidney Transplant Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
Keywords
Analgesia, Chronic kidney disease, Renal Transplant
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Quadratus lumborum block (QLB) group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
efficacy of quadratus lumborum block in post-operative analgesia in kidney transplant surgery
Intervention Description
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
Intervention Name(s)
general anesthesia
Intervention Description
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 Outcome Measure Information:
Title
consumption of morphine
Description
Total consumption of morphine during the first day after surgery
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
consumption of ULTIVA
Description
Total consumption of ULTIVA during the surgery
Time Frame
Day 0
Title
Pain evaluation
Description
Pain evaluation at various timepoints by Visual Analog Scale
Time Frame
Hour 1
Title
Pain evaluation
Description
Pain evaluation at various timepoints by Visual Analog Scale
Time Frame
Hour 2
Title
Pain evaluation
Description
Pain evaluation at various timepoints by Visual Analog Scale
Time Frame
Hour 6
Title
Pain evaluation
Description
Pain evaluation at various timepoints by Visual Analog Scale
Time Frame
Hour 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francois-Xavier ROMAIN
Phone
03 10 73 62 05
Ext
0033
Email
fxromain@chu-reims.fr
Facility Information:
Facility Name
Damien JOLLY
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François-Xavier ROMAIN
Phone
03 10 73 62 05
Ext
0033
Email
fxromain@chu-reims.fr
12. IPD Sharing Statement
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New Approach of Loco Regional Analgesia in Kidney Transplant
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