SurgeryPhase 4PRPKNCT04890418
Risk Factors and Prevention of Severe Pain Upon Cessation of a Peripheral Nerve Block
A Phase 4 study testing Ketalar, 5 mg/mL Injectable Solution in people with Surgery, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Surgery
- What is being tested?
- Ketalar, 5 mg/mL Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2020to 1 Jul 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- any ambulatory upper limb bone surgery carried out under axillary PNB
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, 1200
Patricia LAVAND'HOMME, PhD, 3227641897, patricia.lavandhomme@uclouvain.be
Nassim TOUIL, MD, 3227641888, nassim.touil@uclouvain.be
About this study
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
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.
Read the 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.
- Conditions
- Surgery
- Being tested
- Ketalar, 5 mg/mL Injectable Solution, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketalar, 5 mg/mL Injectable SolutionDrug
Also called Active comparator
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.
PlaceboOther
Also called Placebo comparator
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of severe postoperative rebound pain
Rebound pain after PNB is defined as a Numerical rating Scale of 7 or more.
Measured: 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
Central sensitivity analyzed by a questionnaire and by Numerical Rating Scale
Measured: from surgery to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start1 Jan 2020
- Primary completion31 May 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890418
- Sponsor's protocol ID
- 2019/05JUL/303
- Acronym
- PRPK
- Status last verified
- May 2021
- First submitted
- 3 Mar 2020
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04890418
- Acronym / sponsor ID
- PRPK / 2019/05JUL/303
- Conditions
- Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study drug | Active comparator | Drug: Ketalar, 5 mg/mL Injectable Solution0.3 mg/kg intravenous ketamine diluted into 10mL saline after the realization of peripheral nerve block (PNB), before tourniquet set up and beginning of surgery |
| Placebo | Placebo comparator | Other: Placebo10 mL 0.9% saline after the realization of PNB, before tourniquet set up and beginning of surgery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- any ambulatory upper limb bone surgery carried out under axillary PNB
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketalar, 5 mg/mL Injectable SolutionAlso: Active comparatorThe 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. | Drug | Study drug |
| PlaceboAlso: Placebo comparatorThe 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 | Placebo |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketalar, 5 mg/mL Injectable Solution in people with Surgery, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia Lavand'homme (+3224741888, patricia.lavandhomme@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of severe postoperative rebound pain (time frame: from surgery to 30 days post operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.