Surgery
Conditions
Brief summary
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.
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.
Interventions
DRUGKetalar, 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.
OTHERPlacebo
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.
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The local pharmacy department is in charge of unmasking the drug.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of severe postoperative rebound pain | from surgery to 30 days post operation | Rebound pain after PNB is defined as a Numerical rating Scale of 7 or more. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To measure the impact of ketamine on the level of rebound pain in patients with central sensitivity using the Numerical Rating Scale | from surgery to 30 days postoperatively | Central sensitivity analyzed by a questionnaire and by Numerical Rating Scale |
Countries
Belgium
Contacts
Primary ContactPatricia Lavand'homme
Backup ContactNassim Touil
Outcome results
None listed