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

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)

Overall Status

Recruiting

CT.gov ID

NCT04890418

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery	Drug: Ketalar, 5 mg/mL Injectable Solution Other: Placebo	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

The local pharmacy department is in charge of unmasking the drug.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

May 31, 2021

Anticipated Study Completion Date :

Jul 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cliniques Universitaires Saint-Luc	Brussels		Belgium	1200

Sponsors and Collaborators

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

ClinicalTrials.gov Identifier:

NCT04890418

Other Study ID Numbers:

2019/05JUL/303

First Posted:

May 18, 2021

Last Update Posted:

May 18, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ketamine

Study Results

No Results Posted as of May 18, 2021