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

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ClinicalTrials.gov Identifier: NCT04890418
Recruitment Status : Recruiting
First Posted : May 18, 2021
Last Update Posted : May 18, 2021
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Tracking Information
First Submitted Date  ICMJE March 3, 2020
First Posted Date  ICMJE May 18, 2021
Last Update Posted Date May 18, 2021
Actual Study Start Date  ICMJE January 1, 2020
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2021)
incidence of severe postoperative rebound pain [ Time Frame: from surgery to 30 days post operation ]
Rebound pain after PNB is defined as a Numerical rating Scale of 7 or more.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2021)
To measure the impact of ketamine on the level of "rebound pain" in patients with central sensitivity using the Numerical Rating Scale [ Time Frame: from surgery to 30 days postoperatively ]
Central sensitivity analyzed by a questionnaire and by Numerical Rating Scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Risk Factors and Prevention of Severe Pain Upon Cessation of a Peripheral Nerve Block
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Surgery
Intervention  ICMJE
  • 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 Name: Active comparator
  • 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 Name: Placebo comparator
Study Arms  ICMJE
  • 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
    Intervention: Drug: Ketalar, 5 mg/mL Injectable Solution
  • Placebo Comparator: Placebo
    10 mL 0.9% saline after the realization of PNB, before tourniquet set up and beginning of surgery
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 17, 2021)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Patricia Lavand'homme +3224741888 patricia.lavandhomme@uclouvain.be
Contact: Nassim Touil +3224741888 nassim.touil@uclouvain.be
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04890418
Other Study ID Numbers  ICMJE 2019/05JUL/303
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP