Risk Factors and Prevention of Severe Pain Upon Cessation of a Peripheral Nerve Block
NCT ID: NCT04890418
Last Updated: 2021-05-18
Study Results
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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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2020-01-01
2021-07-01
Brief Summary
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Detailed Description
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Severe post-operative pain is a risk factor for chronic pain. Use of a well-known molecule, regularly used in anesthesiology. Prospective double-blind study on 120 patients. Pain rebound upon awakening of the axillary plexus during upper limb bone surgery is a frequent phenomenon in post-operative follow-up of patients.
The anti-hyperalgesic properties of ketamine could be a benefit against this effect.
No studies have combined intravenous ketamine with localoregional anesthesia to reduce pain upon its release.
This may improve patients' post-operative comfort. The patients will be randomized in 2 groups and allocated to receive (slow intravenous injection) either 0.3 mg/kg intravenous ketamine diluted into 10mL saline or 10 mL 0.9% saline after the realization of PNB, before tourniquet set up and beginning of surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Study drug
0.3 mg/kg intravenous ketamine diluted into 10mL saline after the realization of peripheral nerve block (PNB), before tourniquet set up and beginning of surgery
Ketalar, 5 mg/mL Injectable Solution
The patients will receive (slow intravenous injection) 0.3 mg/kg intravenous ketamine diluted by the pharmacy department into 10mL saline after the realization of PNB but before tourniquet set up and before start of surgery.
Placebo
10 mL 0.9% saline after the realization of PNB, before tourniquet set up and beginning of surgery
Placebo
The patients will receive 10 mL of 0.9% saline. This injection is also performed after the realization of PNB but before tourniquet set up and before start of surgery.
Interventions
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Ketalar, 5 mg/mL Injectable Solution
The patients will receive (slow intravenous injection) 0.3 mg/kg intravenous ketamine diluted by the pharmacy department into 10mL saline after the realization of PNB but before tourniquet set up and before start of surgery.
Placebo
The patients will receive 10 mL of 0.9% saline. This injection is also performed after the realization of PNB but before tourniquet set up and before start of surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Contraindication to the use of ketamine
* Contraindication to regular use of postoperative analgesics like non-steroidal anti-inflammatory drugs and paracetamol
* Pregnant woman
* Diabetic patient
* Vascular patient
* Cognitive disorders
* Inability to answer perioperative questionnaires (language problem)
18 Years
85 Years
ALL
No
Sponsors
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Cliniques universitaires Saint-Luc- Université Catholique de Louvain
OTHER
Responsible Party
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Locations
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Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019/05JUL/303
Identifier Type: -
Identifier Source: org_study_id
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