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

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

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: Interventional
• Enrollment (Anticipated): 100
• 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

• Belgium
  • 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: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

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	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 Names: Active comparator
Placebo Comparator: Placebo; 10 mL 0.9% saline after the realization of PNB, before tourniquet set up and beginning 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.; Other Names: Placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

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	Central sensitivity analyzed by a questionnaire and by Numerical Rating Scale	from surgery to 30 days postoperatively

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): May 31, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 17, 2021
• Last Verified: May 1, 2021

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)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No