Overview

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

Status:
Completed
Trial end date:
2018-10-16
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Treatments:
BB 1101
Dexamethasone
Dexamethasone acetate
Mepivacaine
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- evolving virosis (hepatitis, herpes, shingles and chickenpox)

- Psychotic states not controlled by treatment

- Dexamethasone (Mylan 4 mg/1 mL) allergy or intolerance

- Patient refusal

- Incapacity to consent: Any disease that may invalidate the understanding of protocol
information and informed consent.

- Participation to an other study

- Patient under trusteeship