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

NCT05763433 | Unknown

• 1 other identifier: 2022/28SEP/358
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Adjuvants, Anesthesia; Brachial Plexus Anesthesia

Outcome Measures

Primary Outcomes (6)

• Impact of sexe on the efficacy of DEXA on the occurrence of RP

  \- Sexe (male ,female),

  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),

  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").

  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)

  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)

  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) .

  Through study completion, an average of 1 year

Secondary Outcomes (1)

• Inter-individual variability of preventive efficacy of DEXA

  Through study completion, an average of 1 year

Study Arms (1)

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.

Other: upper extremity bone surgery

Interventions

upper extremity bone surgery OTHER

any ambulatory upper limb bone surgery carried out under axillary PNB

ambulatory upper limb bone surgery carried out under axillary PNB

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

any ambulatory upper limb bone surgery carried out under axillary PNB

You may qualify if:

• Any ambulatory upper limb bone surgery carried out under axillary PNB
• Patient aged between 18 and 75 yrs old

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Related Publications (7)

• 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.

  PMID: 33390261 BACKGROUND

• 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.

  PMID: 35219449 BACKGROUND

• 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.

  PMID: 33589229 BACKGROUND

• 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.

  PMID: 33027077 BACKGROUND

• 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.

  PMID: 32472958 BACKGROUND

• 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.

  PMID: 30124544 BACKGROUND

• Touil 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.

  PMID: 40701886 DERIVED

Study Officials

• Nassim TOUIL, MD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nassim TOUIL, MD

CONTACT

+3227641888; nassim.touil@saintluc.uclouvain.be

Patricia LAVAND'HOMME, MD, PhD

CONTACT

+3227641897; patricia.lavandhomme@saintluc.uclouvain.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: March 10, 2023
• Study Start: March 15, 2023
• Primary Completion: March 15, 2024
• Study Completion: April 1, 2024
• Last Updated: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share