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

Phase 4

• Conditions: Surgery
• Interventions: Drug: Ketalar, 5 mg/mL Injectable Solution; Other: Placebo

• Registration Number: NCT04890418
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-03-03
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-17
• Last Update Submitted: 2021-05-17
• Study First Posted: 2021-05-18
• Last Update Posted: 2021-05-18
• Primary Completion: 2021-05-31
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study drug	Ketalar, 5 mg/mL Injectable Solution	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	10 mL 0.9% saline after the realization of PNB, before tourniquet set up and beginning of surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium