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

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

Tracking Information

• First Submitted Date: March 3, 2020
• First Posted Date: May 18, 2021
• Last Update Posted Date: May 18, 2021
• Actual Study Start Date: January 1, 2020
• Estimated Primary Completion Date: May 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Risk Factors and Prevention of Severe Pain Upon Cessation of a Peripheral Nerve Block
• 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
• 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: Interventional
• Study Phase: Phase 4

Study Design

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: 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 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 17, 2021): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 1, 2021
• Estimated Primary Completion Date: May 31, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Patricia Lavand'homme; +3224741888; patricia.lavandhomme@uclouvain.be

Contact: Nassim Touil; +3224741888; nassim.touil@uclouvain.be

• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT04890418
• Other Study ID Numbers: 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

• 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: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Verification Date: May 2021