Variation in the Effect of Dexamethasone Associated With Axillary Plexus on the Occurrence of Rebound Pain

Adjuvants, Anesthesia Clinical Trial

— VEDR  

Official title:

Evaluation of Intraoperative Dexamethasone Efficacy to Prevent Rebound Pain Phenomenon According to Individual Patient Characteristics

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05763433
• Other study ID #: 2022/28SEP/358
• Status: Not yet recruiting
• Start date: March 15, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: March 2023
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Nassim TOUIL, MD
• Phone: +3227641888
• Email: nassim.touil[@]saintluc.uclouvain.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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).

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Adjuvants, Anesthesia
• Brachial Plexus Anesthesia

Intervention

Other:
• upper extremity bone surgery
any ambulatory upper limb bone surgery carried out under axillary PNB

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

References & Publications (6)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
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