NCT04890418

Risk Factors and Prevention of Severe Pain Upon Cessation of a Peripheral Nerve Block

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgery

Interventions

Type	Name	Description
DRUG	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.
OTHER	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.

Timeline

• Start date: 2020-01-01
• Primary completion: 2021-05-31
• Completion: 2021-07-01
• First posted: 2021-05-18
• Last updated: 2021-05-18

Locations

1 site across 1 country: Belgium