Impact on Sensitivity and Motor Block Duration of an Intravenous Dexamethasone an Axillary Block With Mepivacaine.

NCT03555929 | Completed Phase 3

• 2 other identifiers: P170701J2017-004164-35
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Intravenous dexamethasone is used to increase the duration of analgesia of interscalene bloc for shoulder surgery: it extends from 11h to 23h the sensitivity block in shoulder area. However, the time of dexamethasone intravenous injection has not been studied. In all studies, dexamethasone was injected right after the achievement of loco regional anesthesia. The main objective is to demonstrate that intravenous injection of dexamethasone delayed at 90 minutes in patients who received an axillary block with mepivacaine prolongs the duration of the motor block by 40 minutes.

Conditions

Hand Wound; Wrist Wound; Forearm Wound; Hand Fracture; Wrist Fracture; Forearm Fracture

Keywords

Axillary block; Dexamethasone; anesthesia

Outcome Measures

Primary Outcomes (1)

• Duration of motor block

  The evaluation of the appearance of the motor block is done by a neurological examination of the anesthetized hand and forearm every 5 minutes after injection of the local anesthetic during 20 minutes During the intervention, the reappearance of a movement of the hand or forearm is signaled by the surgeon at the request of the anesthetist and corresponds to the end of the motor block. After the intervention, a neurological examination is performed every 15 minutes in a recovery room until the appearance of the first movement of the hand

  within 3 hours after intervention.

Secondary Outcomes (4)

• Duration of sensitivity block defined as the time between the performance of sensitivity block and appearance of paresthesic or the first analgesia request.

  within 3 hours (for outcome measure 1) (end of intervention for 2 and 3) and at 24 hours after the intervention

• Sedation or general anesthesia request

  within 3 hours (for outcome measure 1) (end of intervention for 2 and 3) and at 24 hours after the intervention

• Pain scores in recovering room

  within 3 hours (for outcome measure 1) (end of intervention for 2 and 3) and at 24 hours after the intervention

• Adverse effects in next 24 hours

  within 3 hours (for outcome measure 1) (end of intervention for 2 and 3) and at 24 hours after the intervention

Study Arms (2)

Dexamethasone

EXPERIMENTAL

Dexamethasone 8 mg/2cc I.V. 90 minutes after axillary block

Drug: Dexamethasone

Normal saline

PLACEBO COMPARATOR

Normal saline 2cc I.V., 90 minutes after axillary block

Drug: Normal saline

Interventions

Dexamethasone DRUG

80 minutes after achievement of axillary block, if the surgery is not ended, patients will be randomly assigned to one of the two groups : DEXA or Control. Injection will be done 90minutes after achievement of axillary block.

Dexamethasone

Normal saline DRUG

80 minutes after achievement of axillary block, if the surgery is not ended, patients will be randomly assigned to one of the two groups : DEXA or Control. Injection will be done 90minutes after achievement of axillary block.

Normal saline

Eligibility Criteria

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

You may qualify if:

• Women or men should be operated on hand, wrist or forearm for an elective surgery or emergency surgery
• The surgery will be provided under axillary block, a loco regional anesthesia made under ultrasonography with mepivacaine.
• Women of childbearing/reproductive potential must have effective contraceptive method defined by a hormonal method or an intrauterine device (IUD) or surgical sterilization of the patient or her partner,
• Patients must have French state medical insurance (Patients adhering to Social Security),
• Patients providing the investigator with a signed informed consent

You may not qualify if:

• Age under 18yrs
• Pregnant or breastfeeding
• Brachial plexus neuropathy
• Hand or forearm injury with nerve injury (unsensitivity or paralysis)
• Other local anesthetic used: lidocaine, ropivacaine, levo bupivacaine
• Planned general anesthesia in association with loco regional anesthesia
• Diabetes
• Current infection on surgical area, puncture area or general bacterial or viral infection.
• Vaccination with attenuated vaccine in the current month
• Porphyry
• Severe hemostasis trouble
• Any contraindication to mepivacaine/axillary block anesthesia, severe heart rate trouble requesting pacemaker (BAVII, BAV3) and uncontrolled epilepsy
• Routine use of systemic corticosteroid or opioid medication
• Known local anesthetics/mepivacaine allergy
• expected duration of surgery less than 60 minutes

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Avicenne

Bobigny, 93000, France

Location

MeSH Terms

Conditions

Hand Injuries; Wrist Injuries; Wrist Fractures

Interventions

Dexamethasone; Saline Solution

Condition Hierarchy (Ancestors)

Wounds and Injuries; Arm Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: June 14, 2018
• Study Start: April 4, 2018
• Primary Completion: October 15, 2018
• Study Completion: October 16, 2018
• Last Updated: June 19, 2019

Record last verified: 2018-03

Locations

FR (1)