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

NCT ID: NCT05763433

Last Updated: 2023-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-15

Study Completion Date

2024-04-01

Brief Summary

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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

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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

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Adjuvants, Anesthesia Brachial Plexus Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

upper extremity bone surgery

Intervention Type OTHER

any ambulatory upper limb bone surgery carried out under axillary PNB

Interventions

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upper extremity bone surgery

any ambulatory upper limb bone surgery carried out under axillary PNB

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nassim TOUIL, MD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Central Contacts

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Nassim TOUIL, MD

Role: CONTACT

+3227641888

Patricia LAVAND'HOMME, MD, PhD

Role: CONTACT

+3227641897

References

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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.

Reference Type BACKGROUND
PMID: 33390261 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35219449 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33589229 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33027077 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32472958 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30124544 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40701886 (View on PubMed)

Other Identifiers

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2022/28SEP/358

Identifier Type: -

Identifier Source: org_study_id

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