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

Surgery Clinical Trial

— PRPK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04890418
• Other study ID #: 2019/05JUL/303
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: May 2021
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Patricia Lavand'homme
• Phone: +3224741888
• Email: patricia.lavandhomme[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Surgery

Intervention

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.

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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