- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04890418
Risk Factors and Prevention of Severe Pain Upon Cessation of a Peripheral Nerve Block (PRPK)
Risk Factors and Prevention of Severe Pain Upon Cessation of a Peripheral Nerve Block. A Prospective Randomized Study in Ambulatory Patients Undergoing Upper Limb Bone Surgery Under Single Shot Axillary Plexus Block
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pain in the course of upper limb bone surgery is a major source of discomfort for patients during postoperative time.
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Patricia Lavand'homme
- Phone Number: +3224741888
- Email: patricia.lavandhomme@uclouvain.be
Study Contact Backup
- Name: Nassim Touil
- Phone Number: +3224741888
- Email: nassim.touil@uclouvain.be
Study Locations
-
-
-
Brussels, Belgium, 1200
- Recruiting
- Cliniques Universitaires Saint-Luc
-
Contact:
- Patricia LAVAND'HOMME, PhD
- Phone Number: 3227641897
- Email: patricia.lavandhomme@uclouvain.be
-
Contact:
- Nassim TOUIL, MD
- Phone Number: 3227641888
- Email: nassim.touil@uclouvain.be
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- any ambulatory upper limb bone surgery carried out under axillary PNB
Exclusion Criteria:
- Refusal to participate
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
|
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.
Other Names:
|
Placebo Comparator: Placebo
10 mL 0.9% saline after the realization of PNB, before tourniquet set up and beginning of surgery
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of severe postoperative rebound pain
Time Frame: from surgery to 30 days post operation
|
Rebound pain after PNB is defined as a Numerical rating Scale of 7 or more.
|
from surgery to 30 days post operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To measure the impact of ketamine on the level of "rebound pain" in patients with central sensitivity using the Numerical Rating Scale
Time Frame: from surgery to 30 days postoperatively
|
Central sensitivity analyzed by a questionnaire and by Numerical Rating Scale
|
from surgery to 30 days postoperatively
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- 2019/05JUL/303
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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