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

NCT04890418 | Unknown Phase 4 DMC

• 1 other identifier: 2019/05JUL/303
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

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

Drug: Ketalar, 5 mg/mL Injectable Solution

Placebo

PLACEBO COMPARATOR

10 mL 0.9% saline after the realization of PNB, before tourniquet set up and beginning of surgery

Other: Placebo

Interventions

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.

Also known as: Active comparator

Study 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.

Also known as: Placebo comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• any ambulatory upper limb bone surgery carried out under axillary PNB

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Patricia Lavand'homme

CONTACT

+3224741888; patricia.lavandhomme@uclouvain.be

Nassim Touil

CONTACT

+3224741888; nassim.touil@uclouvain.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The local pharmacy department is in charge of unmasking the drug.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: May 18, 2021
• Study Start: January 1, 2020
• Primary Completion: May 31, 2021
• Study Completion: July 1, 2021
• Last Updated: May 18, 2021

Record last verified: 2021-05

Locations

BE (1)