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

March 8, 2023 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

any ambulatory upper limb bone surgery carried out under axillary PNB

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
any ambulatory upper limb bone surgery carried out under axillary PNB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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),
Through study completion, an average of 1 year
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),
Through study completion, an average of 1 year
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").
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
Time Frame: Through study completion, an average of 1 year
- 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
Time Frame: Through study completion, an average of 1 year
- 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
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) .
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inter-individual variability of preventive efficacy of DEXA
Time Frame: Through study completion, an average of 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Nassim TOUIL, MD, Cliniques Universitaires Saint-Luc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 15, 2023

Primary Completion (Anticipated)

March 15, 2024

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

January 17, 2023

First Submitted That Met QC Criteria

March 8, 2023

First Posted (Estimate)

March 10, 2023

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

March 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2022/28SEP/358

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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