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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study drug | Active Comparator | 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 |
|
| Placebo | Placebo Comparator | 10 mL 0.9% saline after the realization of PNB, before tourniquet set up and beginning of surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketalar, 5 mg/mL Injectable Solution | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of severe postoperative rebound pain | Rebound pain after PNB is defined as a Numerical rating Scale of 7 or more. | from surgery to 30 days post operation |
| 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 | Central sensitivity analyzed by a questionnaire and by Numerical Rating Scale | from surgery to 30 days postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia Lavand'homme | Contact | +3224741888 | patricia.lavandhomme@uclouvain.be | |
| Nassim Touil | Contact | +3224741888 | nassim.touil@uclouvain.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaires Saint-Luc | Recruiting | Brussels | 1200 | Belgium |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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The local pharmacy department is in charge of unmasking the drug.
|
| Placebo | Other | 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. |
|
|
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |