Adjuvants, Anesthesia Clinical Trial
— VEDROfficial 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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | April 1, 2024 |
Est. primary completion date | March 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Any ambulatory upper limb bone surgery carried out under axillary PNB - Patient aged between 18 and 75 yrs old Exclusion Criteria: - 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 - Vascular patient - Cognitive disorders - Inability to answer perioperative questionnaires (language problem) |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
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. — View Citation
Desai 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. — View Citation
Holmberg 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. — View Citation
Lavand'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. — View Citation
Stubbs 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. — View Citation
Touil 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
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Primary | Impact of sexe on the efficacy of DEXA on the occurrence of RP | - Sexe (male ,female), | Through study completion, an average of 1 year | |
Primary | 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), | Through study completion, an average of 1 year | |
Primary | 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"). | Through study completion, an average of 1 year | |
Primary | 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) | Through study completion, an average of 1 year | |
Primary | 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) | Through study completion, an average of 1 year | |
Primary | 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) . | Through study completion, an average of 1 year | |
Secondary | 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. | Through study completion, an average of 1 year |
Status | Clinical Trial | Phase | |
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Active, not recruiting |
NCT01739270 -
Dexamethasone Added to Levobupivacaine Improves Postoperative Analgesia
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N/A | |
Completed |
NCT02393677 -
Supraclavicular Brachial Plexus Block Using Ropivacaine Alone and With Dexmedetomidine
|
N/A |