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

NCT ID: NCT03555929

Last Updated: 2019-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-04
• Study Completion Date: 2018-10-16

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.

Detailed Description

In orthopedic surgery, most of procedures are made under loco regional anesthesia. For a surgery of hand, wrist or forearm, an axillary block is made to obtain an insensitivity (sensitivity block) and an unability to move from elbow to fingers (motor block). Depending on the duration of surgery, less or more than 2 hours, a choice of anesthetic has to be made. For short surgeries, mepivacaine is taken on, but for longer ones, local anesthetics like ropivacaine or levo bupivacaine are recommended. Nevertheless, once surgery started, there isn't any possibility to extend the anesthesia duration in case of an unexpected increase of surgery length. A general anesthesia will therefore be required.

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(1). 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 investigator hypothesized that intravenous dexamethasone could extend anesthetic duration of a mepivacaine axillary block (motor and sensitivity block length) even though dexamethasone was injected 90 min after the achievement of block and could be a good option in case of an unexpected extended surgery.

In orthopedic surgery, most of procedures are made under loco regional anesthesia. For a surgery of hand, wrist or forearm, an axillary block is made to obtain an insensitivity (sensitivity block) and an unability to move from elbow to fingers (motor block). Depending on the duration of surgery, less or more than 2 hours, a choice of anesthetic has to be made. For short surgeries, mepivacaine is taken on, but for longer ones, local anesthetics like ropivacaine or levo bupivacaine are recommended. Nevertheless, once surgery started, there isn't any possibility to extend the anesthesia duration in case of an unexpected increase of surgery length. A general anesthesia will therefore be required.

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(1). 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 investigator hypothesized that intravenous dexamethasone could extend anesthetic duration of a mepivacaine axillary block (motor and sensitivity block length) even though dexamethasone was injected 90 min after the achievement of block and could be a good option in case of an unexpected extended surgery.

52 patients will be randomly assigned to two groups:

• DEXA: dexamethasone 8 mg/2cc I.V. 90 minutes after axillary block
• Control: Normal saline 2cc I.V., 90 minutes after axillary block These patients will be recruited during the anesthesia interview from 1 hospital, with 5 surgeons performing the surgeries and 15 anesthetists performing the axillary block

1. After written consent, all patients will have their surgery under regional anesthesia only provided by the axillary block, with mepivacaine 1.5% 25cc.

2. Time of complete motor and sensitivity block will be monitored and recorded

3. 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

4. Injection will be done 90minutes after achievement of axillary block

5. Monitoring of motor block and sensitivity block recovery will be done :

• during the surgery by nurse and surgeon
• after the surgery in recovering room by nurses each 15min.

6. Patients will be called on post operative day one for pain evaluation and detection of adverse effects.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dexamethasone

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

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: 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.

Interventions

Dexamethasone

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.

Intervention Type: DRUG

Normal saline

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Avicenne

Bobigny, , France

Countries

France

Other Identifiers

2017-004164-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P170701J

Identifier Type: -

Identifier Source: org_study_id