Chronic Kidney DiseasesCARRENALNCT05391451
New Approach of Loco Regional Analgesia in Kidney Transplant
A study testing efficacy of quadratus lumborum block in post-operative analgesia in kidney transplant surgery and general anesthesia in people with Chronic Kidney Diseases, run by CHU de Reims at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- efficacy of quadratus lumborum block in post-operative analgesia in kidney transplant surgery and general anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 31 Aug 2021to 23 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Legally protected
- Known allergy to local anesthetics used
- Manifest polyneuropathy
- ASA score > 4
- Pregnancy, breastfeeding
- Contraindications to QLB
Show all 9Show fewer
- Technique refusal
- Previous kidney transplant
- History of major abdominal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy of the Quadratus Lumborum Block for Analgesia in Kidney Transplant Surgery
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.
- Conditions
- Chronic Kidney Diseases
- Being tested
- efficacy of quadratus lumborum block in post-operative analgesia in kidney transplant surgery, general anesthesia
- Keywords
- Analgesia, Chronic kidney disease, Renal Transplant
- Medical subject headings
- Renal Insufficiency, Chronic, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efficacy of quadratus lumborum block in post-operative analgesia in kidney transplant surgeryProcedure or 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
general anesthesiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Quadratus lumborum block (QLB) group | Experimental | Not described Receives: Procedure: efficacy of quadratus lumborum block in post-operative analgesia in kidney transplant surgery |
| Control group | Active comparator | Not described Receives: Procedure: general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
consumption of morphine
Total consumption of morphine during the first day after surgery
Measured: Day 1
Secondary outcomes (5)
consumption of ULTIVA
Total consumption of ULTIVA during the surgery
Measured: Day 0
Pain evaluation
Pain evaluation at various timepoints by Visual Analog Scale
Measured: Hour 1
Pain evaluation
Pain evaluation at various timepoints by Visual Analog Scale
Measured: Hour 2
Pain evaluation
Pain evaluation at various timepoints by Visual Analog Scale
Measured: Hour 6
Pain evaluation
Pain evaluation at various timepoints by Visual Analog Scale
Measured: Hour 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start31 Aug 2021
- Primary completion23 Sep 2022
- Study completion23 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391451
- Sponsor's protocol ID
- PO21061
- Acronym
- CARRENAL
- Status last verified
- Nov 2024
- First submitted
- 19 May 2022
- Last updated
- 29 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of the Quadratus Lumborum Block for Analgesia in Kidney Transplant Surgery
- ClinicalTrials.gov ID
- NCT05391451
- Acronym / sponsor ID
- CARRENAL / PO21061
- Conditions
- Chronic Kidney Diseases
- Keywords
- Analgesia, Chronic kidney disease, Renal Transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 23 Sep 2022 (actual)
- Study completion
- 23 Oct 2022 (actual)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Legally protected
- Known allergy to local anesthetics used
- Manifest polyneuropathy
- ASA score > 4
- Pregnancy, breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| efficacy of quadratus lumborum block in post-operative analgesia in kidney transplant surgeryno 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 | Procedure or surgery | Quadratus lumborum block (QLB) group |
| general anesthesiageneral 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. | Procedure or surgery | Control group |
Primary outcome
consumption of morphine
Time frame: Day 1
Total consumption of morphine during the first day after surgery
5 secondary outcomes
consumption of ULTIVA
Time frame: Day 0
Pain evaluation
Time frame: Hour 1
Pain evaluation
Time frame: Hour 2
Pain evaluation
Time frame: Hour 6
Pain evaluation
Time frame: Hour 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing efficacy of quadratus lumborum block in post-operative analgesia in kidney transplant surgery and general anesthesia in people with Chronic Kidney Diseases, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
consumption of morphine (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.