Adjuvants, AnesthesiaVEDRNCT05763433
Variation in the Effect of Dexamethasone Associated With Axillary Plexus on the Occurrence of Rebound Pain
An observational study of Adjuvants, Anesthesia and Brachial Plexus Anesthesia, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Trial summary
The study will evaluate pain and recovery after a single injection axillary plexus block combined with an intravenous dose of 0.1 mg/kg dexamethasone in ambulatory patients undergoing upper extremity bone surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adjuvants, Anesthesia, Brachial Plexus Anesthesia
- What is being tested?
- upper extremity bone surgery
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2023to 1 Apr 2024
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: any ambulatory upper limb bone surgery carried out under axillary PNB
Who may be able to join
- Any ambulatory upper limb bone surgery carried out under axillary PNB
- Patient aged between 18 and 75 yrs old
Who cannot join
- Refusal to participate
- Contraindication to the use of Dexamethasone
- Patient with corticoids intake for various reasons
- Contraindication to regular use of postoperative analgesics like non-steroidal anti-inflammatory drugs and paracetamol
- Pregnant woman
- Diabetic patient
Show all 9Show fewer
- Vascular patient
- Cognitive disorders
- Inability to answer perioperative questionnaires (language problem)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Intraoperative Dexamethasone Efficacy to Prevent Rebound Pain Phenomenon According to Individual Patient Characteristics
The study will evaluate pain and recovery after a single injection axillary plexus block combined with an intravenous dose of 0.1 mg/kg dexamethasone in ambulatory patients undergoing upper extremity bone surgery. The investigators will try to identify the risk factors involved in a decrease in the efficacy of dexamethaxone for the prevention of RP.
The hypotheses are that :
- The interindividual variability may modulate the preventive effect on "rebound pain" after axillary block, of pre-incisional administration of an anti-inflammatory dose of dexamethasone (0.1 mg/kg max 10 mg).
- Patients with increased preoperative anxiety or underlying catastrophizing will experience more postoperative pain as the axillary PNB dissipates.
- Elevated preoperative salivary lipocortin 1 and cortisol levels result in a lesser preventive effect of dexamethasone on the development of rebound pain.
Read the detailed description
The use of a peripheral nerve block (PNB) through local anesthetics administered may exacerbate the acute inflammatory process induced by the surgical trauma, which may cause rebound pain once the block is lifted, also called "Rebound pain" (RP).
The administration of a dose of Dexamethasone (DEXA) IV as an adjuvant, to optimize the effectiveness of PNB by increasing the duration of PNB , is already a validated practice in anesthesia. In addition the well known analgesic effects of DEXA on postoperative pain (dose> 0.1 mg/kg) seem to contribute to the decrease in RP occurring in the first 24 hours after surgery . These protective properties of DEXA with respect to this phenomenon of hyperalgesia could be explained, among other things, by its modulatory actions on the inflammatory reaction and inhibitory actions on cyclooxygenase as well as its effect on the production of specific mediators such as cytokines.
However, even if DEXA can reduce the onset of RP in some patients, its efficacy seems to be variable and inconsistent between individuals, as suggested by the results of a retrospective observational study .
It can thus be assumed that some individuals are less sensitive to the preventive administration of DEXA and this for different reasons that it would be interesting to better understand .
Objectives:The primary objective will be to identify factors predisposing to variations in the efficacy of DEXA on the occurrence of RP by characterizing the basal stress state of the patient, the level of anxiety and pre-existing catastrophism, as well as the basal thresholds of Lipocortin 1 and cortisol and the basal inflammatory degree (CR high sensitivity) The secondary objective will be to evaluate the interindividual variability of the preventive efficacy of pre-incisional systemic administration of an anti-inflammatory dose of DEXA (0.1 mg/kg, 10 mg maximum) on the occurrence of RP during axillary block removal.
Method: Patients scheduled for elective upper extremity surgery will receive an axillary nerve block. An intravenous injection of DEXA 0.1mg/kg preoperatively will be offered to all patients included in the study. The PNB will be performed under real-time ultrasound guidance by a competent anesthesiologist using a local anesthetic solution of MEPIVACAINE 1%, for volumes administered varying between 15 and 30 ml (maximum 400 mg, 5-6 mg/Kg). The intensity, the neuropathic or catastrophic character of the pain as well as the preoperative anxiety will be collected through specific questionnaires (APAIS /Catastrophisation /CSI /NLR...). In addition, salivary samples of free cortisol and Lipocortin 1 and blood samples (CRP hs and NLR) will be collected before the PNB is performed. All patients will receive, if necessary, an adapted analgesia in the postoperative period and in the recovery room. Patients will be discharged with a standardized analgesic treatment. Patients will be followed up according to the study protocol established in the PACU (recovery room) at D1 to D4 D30 and at 3 months postoperatively (by telephone calls).
- Conditions
- Adjuvants, Anesthesia, Brachial Plexus Anesthesia
- Being tested
- upper extremity bone surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upper extremity bone surgeryOther
any ambulatory upper limb bone surgery carried out under axillary PNB
| Study group | Role | What they receive |
|---|---|---|
| ambulatory upper limb bone surgery carried out under axillary PNB | Patients will receive a slow intravenous injection of 0.1mg/kg max 10 mg intravenous dexamethasone in a 2cc syringe (5 mg/cc dexamethasone) after PNB is performed, prior to tourniquet placement and the start of surgery. Receives: Other: upper extremity bone surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of sexe on the efficacy of DEXA on the occurrence of RP
- Sexe (male ,female),
Measured: Through study completion, an average of 1 year
Impact of BMI on the efficacy of DEXA on the occurrence of RP
- Body mass index BMI (combination of weight measurement in Kilograms and height in meters to obtain BMI in kg/m^2),
Measured: Through study completion, an average of 1 year
Impact of preoperative anxiety levels on the efficacy of DEXA on the occurrence of RP
- Preoperative anxiety levels (APAIS scale). The score can range from 6 ("no anxiety") to 30 ("very anxious").
Measured: Through study completion, an average of 1 year
Impact of preoperative levels of pre-existing catastrophizin on the efficacy of DEXA on the occurrence of RP
- Preoperative levels of pre-existing catastrophizing .(13 items scored from 0 to 4)
Measured: Through study completion, an average of 1 year
Impact of preoperative levels of central sensitization on the efficacy of DEXA on the occurrence of RP
- Preoperative levels of central sensitization index (CSI) (9 questions)
Measured: Through study completion, an average of 1 year
Impact of baseline levels of Lipocortin 1 and cortisol on the efficacy of DEXA on the occurrence of RP
- Baseline levels of Lipocortin 1 and cortisol (salivary assays in nmol/L) and measurements of blood mediators of inflammation, C-Réactive Proteine (CRP) value (in milligrams/liter) and NLR value (neutrophil to lymphocyte ratio) .
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Inter-individual variability of preventive efficacy of DEXA
The investigators wish to demonstrate inter-individual variability in the incidence of pain rebound despite systemic pre-incisional preventive administration of an anti-inflammatory dose of DEXA (0.1 mg/kg, 10 mg maximum) for all patients included in the study.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start15 Mar 2023 (estimated)
- Primary completion15 Mar 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Adjuvants, AnesthesiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nassim TOUIL, MD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763433
- Sponsor's protocol ID
- 2022/28SEP/358
- Acronym
- VEDR
- Status last verified
- Mar 2023
- First submitted
- 17 Jan 2023
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barry GS, Bailey JG, Sardinha J, Brousseau P, Uppal V. Factors associated with rebound pain after peripheral nerve block for ambulatory surgery. Br J Anaesth. 2021 Apr;126(4):862-871. doi: 10.1016/j.bja.2020.10.035. Epub 2020 Dec 31.
PubMed 33390261Touil N, Pavlopoulou A, Barbier O, Libouton X, Lavand'homme P. Evaluation of intraoperative ketamine on the prevention of severe rebound pain upon cessation of peripheral nerve block: a prospective randomised, double-blind, placebo-controlled study. Br J Anaesth. 2022 Apr;128(4):734-741. doi: 10.1016/j.bja.2021.11.043. Epub 2022 Feb 23.
PubMed 35219449Stubbs DJ, Levy N. Role of dexamethasone in reducing postoperative pain. Comment on Br J Anaesth 2021; 126: 862-71. Br J Anaesth. 2021 Apr;126(4):e139-e140. doi: 10.1016/j.bja.2021.01.010. Epub 2021 Feb 13. No abstract available.
PubMed 33589229Desai N, El-Boghdadly K, Albrecht E. Peripheral nerve blockade and novel analgesic modalities for ambulatory anesthesia. Curr Opin Anaesthesiol. 2020 Dec;33(6):760-767. doi: 10.1097/ACO.0000000000000928.
PubMed 33027077Holmberg A, Hassellund SS, Draegni T, Nordby A, Ottesen FS, Gulestol A, Raeder J. Analgesic effect of intravenous dexamethasone after volar plate surgery for distal radius fracture with brachial plexus block anaesthesia: a prospective, double-blind randomised clinical trial. Anaesthesia. 2020 Nov;75(11):1448-1460. doi: 10.1111/anae.15111. Epub 2020 May 30.
PubMed 32472958Lavand'homme P. Rebound pain after regional anesthesia in the ambulatory patient. Curr Opin Anaesthesiol. 2018 Dec;31(6):679-684. doi: 10.1097/ACO.0000000000000651.
PubMed 30124544Touil N, Pavlopoulou A, Barbier O, Libouton X, Gruson D, Gala JL, Lavand'homme P. Factors associated with a reduction in the preventive effect of intravenous dexamethasone on rebound pain after axillary brachial plexus block. Br J Anaesth. 2025 Oct;135(4):1059-1066. doi: 10.1016/j.bja.2025.05.055. Epub 2025 Jul 22.
PubMed 40701886
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intraoperative Dexamethasone Efficacy to Prevent Rebound Pain Phenomenon According to Individual Patient Characteristics
- ClinicalTrials.gov ID
- NCT05763433
- Acronym / sponsor ID
- VEDR / 2022/28SEP/358
- Conditions
- Adjuvants, Anesthesia, Brachial Plexus Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 15 Mar 2023 (estimated)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 10 Mar 2023 (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.
The study will evaluate pain and recovery after a single injection axillary plexus block combined with an intravenous dose of 0.1 mg/kg dexamethasone in ambulatory patients undergoing upper extremity bone surgery. The investigators will try to identify the risk factors involved in a decrease in the efficacy of dexamethaxone for the prevention of RP.
The hypotheses are that :
- The interindividual variability may modulate the preventive effect on "rebound pain" after axillary block, of pre-incisional administration of an anti-inflammatory dose of dexamethasone (0.1 mg/kg max 10 mg).
- Patients with increased preoperative anxiety or underlying catastrophizing will experience more postoperative pain as the axillary PNB dissipates.
- Elevated preoperative salivary lipocortin 1 and cortisol levels result in a lesser preventive effect of dexamethasone on the development of rebound pain.
Detailed description
The use of a peripheral nerve block (PNB) through local anesthetics administered may exacerbate the acute inflammatory process induced by the surgical trauma, which may cause rebound pain once the block is lifted, also called "Rebound pain" (RP).
The administration of a dose of Dexamethasone (DEXA) IV as an adjuvant, to optimize the effectiveness of PNB by increasing the duration of PNB , is already a validated practice in anesthesia. In addition the well known analgesic effects of DEXA on postoperative pain (dose> 0.1 mg/kg) seem to contribute to the decrease in RP occurring in the first 24 hours after surgery . These protective properties of DEXA with respect to this phenomenon of hyperalgesia could be explained, among other things, by its modulatory actions on the inflammatory reaction and inhibitory actions on cyclooxygenase as well as its effect on the production of specific mediators such as cytokines.
However, even if DEXA can reduce the onset of RP in some patients, its efficacy seems to be variable and inconsistent between individuals, as suggested by the results of a retrospective observational study .
It can thus be assumed that some individuals are less sensitive to the preventive administration of DEXA and this for different reasons that it would be interesting to better understand .
Objectives:The primary objective will be to identify factors predisposing to variations in the efficacy of DEXA on the occurrence of RP by characterizing the basal stress state of the patient, the level of anxiety and pre-existing catastrophism, as well as the basal thresholds of Lipocortin 1 and cortisol and the basal inflammatory degree (CR high sensitivity) The secondary objective will be to evaluate the interindividual variability of the preventive efficacy of pre-incisional systemic administration of an anti-inflammatory dose of DEXA (0.1 mg/kg, 10 mg maximum) on the occurrence of RP during axillary block removal.
Method: Patients scheduled for elective upper extremity surgery will receive an axillary nerve block. An intravenous injection of DEXA 0.1mg/kg preoperatively will be offered to all patients included in the study. The PNB will be performed under real-time ultrasound guidance by a competent anesthesiologist using a local anesthetic solution of MEPIVACAINE 1%, for volumes administered varying between 15 and 30 ml (maximum 400 mg, 5-6 mg/Kg). The intensity, the neuropathic or catastrophic character of the pain as well as the preoperative anxiety will be collected through specific questionnaires (APAIS /Catastrophisation /CSI /NLR...). In addition, salivary samples of free cortisol and Lipocortin 1 and blood samples (CRP hs and NLR) will be collected before the PNB is performed. All patients will receive, if necessary, an adapted analgesia in the postoperative period and in the recovery room. Patients will be discharged with a standardized analgesic treatment. Patients will be followed up according to the study protocol established in the PACU (recovery room) at D1 to D4 D30 and at 3 months postoperatively (by telephone calls).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ambulatory upper limb bone surgery carried out under axillary PNB | – | Other: upper extremity bone surgeryPatients will receive a slow intravenous injection of 0.1mg/kg max 10 mg intravenous dexamethasone in a 2cc syringe (5 mg/cc dexamethasone) after PNB is performed, prior to tourniquet placement and the start of surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- any ambulatory upper limb bone surgery carried out under axillary PNB
Key inclusion criteria (2 listed)
- Any ambulatory upper limb bone surgery carried out under axillary PNB
- Patient aged between 18 and 75 yrs old
Key exclusion criteria (9 listed)
- Refusal to participate
- Contraindication to the use of Dexamethasone
- Patient with corticoids intake for various reasons
- Contraindication to regular use of postoperative analgesics like non-steroidal anti-inflammatory drugs and paracetamol
- Pregnant woman
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 |
|---|---|---|
| upper extremity bone surgeryany ambulatory upper limb bone surgery carried out under axillary PNB | Other | ambulatory upper limb bone surgery carried out under axillary PNB |
Primary outcome
Impact of sexe on the efficacy of DEXA on the occurrence of RP
Time frame: Through study completion, an average of 1 year
- Sexe (male ,female),
Impact of BMI on the efficacy of DEXA on the occurrence of RP
Time frame: Through study completion, an average of 1 year
- Body mass index BMI (combination of weight measurement in Kilograms and height in meters to obtain BMI in kg/m^2),
Impact of preoperative anxiety levels on the efficacy of DEXA on the occurrence of RP
Time frame: Through study completion, an average of 1 year
- Preoperative anxiety levels (APAIS scale). The score can range from 6 ("no anxiety") to 30 ("very anxious").
Impact of preoperative levels of pre-existing catastrophizin on the efficacy of DEXA on the occurrence of RP
Time frame: Through study completion, an average of 1 year
- Preoperative levels of pre-existing catastrophizing .(13 items scored from 0 to 4)
Impact of preoperative levels of central sensitization on the efficacy of DEXA on the occurrence of RP
Time frame: Through study completion, an average of 1 year
- Preoperative levels of central sensitization index (CSI) (9 questions)
Impact of baseline levels of Lipocortin 1 and cortisol on the efficacy of DEXA on the occurrence of RP
Time frame: Through study completion, an average of 1 year
- Baseline levels of Lipocortin 1 and cortisol (salivary assays in nmol/L) and measurements of blood mediators of inflammation, C-Réactive Proteine (CRP) value (in milligrams/liter) and NLR value (neutrophil to lymphocyte ratio) .
1 secondary outcome
Inter-individual variability of preventive efficacy of DEXA
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Background: PubMed 33390261Barry GS, Bailey JG, Sardinha J, Brousseau P, Uppal V. Factors associated with rebound pain after peripheral nerve block for ambulatory surgery. Br J Anaesth. 2021 Apr;126(4):862-871. doi: 10.1016/j.bja.2020.10.035. Epub 2020 Dec 31.
- Background: PubMed 35219449Touil N, Pavlopoulou A, Barbier O, Libouton X, Lavand'homme P. Evaluation of intraoperative ketamine on the prevention of severe rebound pain upon cessation of peripheral nerve block: a prospective randomised, double-blind, placebo-controlled study. Br J Anaesth. 2022 Apr;128(4):734-741. doi: 10.1016/j.bja.2021.11.043. Epub 2022 Feb 23.
- Background: PubMed 33589229Stubbs DJ, Levy N. Role of dexamethasone in reducing postoperative pain. Comment on Br J Anaesth 2021; 126: 862-71. Br J Anaesth. 2021 Apr;126(4):e139-e140. doi: 10.1016/j.bja.2021.01.010. Epub 2021 Feb 13. No abstract available.
- Background: PubMed 33027077Desai N, El-Boghdadly K, Albrecht E. Peripheral nerve blockade and novel analgesic modalities for ambulatory anesthesia. Curr Opin Anaesthesiol. 2020 Dec;33(6):760-767. doi: 10.1097/ACO.0000000000000928.
- Background: PubMed 32472958Holmberg A, Hassellund SS, Draegni T, Nordby A, Ottesen FS, Gulestol A, Raeder J. Analgesic effect of intravenous dexamethasone after volar plate surgery for distal radius fracture with brachial plexus block anaesthesia: a prospective, double-blind randomised clinical trial. Anaesthesia. 2020 Nov;75(11):1448-1460. doi: 10.1111/anae.15111. Epub 2020 May 30.
- Background: PubMed 30124544Lavand'homme P. Rebound pain after regional anesthesia in the ambulatory patient. Curr Opin Anaesthesiol. 2018 Dec;31(6):679-684. doi: 10.1097/ACO.0000000000000651.
- Derived from this study: PubMed 40701886Touil N, Pavlopoulou A, Barbier O, Libouton X, Gruson D, Gala JL, Lavand'homme P. Factors associated with a reduction in the preventive effect of intravenous dexamethasone on rebound pain after axillary brachial plexus block. Br J Anaesth. 2025 Oct;135(4):1059-1066. doi: 10.1016/j.bja.2025.05.055. Epub 2025 Jul 22.
- Individual participant dataSharing planned: No
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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.
Nassim TOUIL, MD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Questions about this trial
What is this clinical trial studying?
An observational study of Adjuvants, Anesthesia and Brachial Plexus Anesthesia, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
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 2 inclusion and 9 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 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Nassim TOUIL, MD (+3227641888, nassim.touil@saintluc.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of sexe on the efficacy of DEXA on the occurrence of RP (time frame: Through study completion, an average of 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05763433, which also lists 7 linked publications.
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 10 Mar 2023.