DEXA-rescue: Impact on Sensitivity and Motor Block Duration of an Intravenous Dexamethasone an Axillary Block With Mepivacaine.

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT03555929

Collaborator

(none)

Enrollment

Location

Arms

6.4

Actual Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hand Wound Wrist Wound Forearm Wound Hand Fracture Wrist Fracture Forearm Fracture	Drug: Dexamethasone Drug: Normal saline	Phase 3

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.

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.

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

After written consent, all patients will have their surgery under regional anesthesia only provided by the axillary block, with mepivacaine 1.5% 25cc.
Time of complete motor and sensitivity block will be monitored and recorded
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
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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Impact on Sensitivity and Motor Block Duration of an Intravenous Dexamethasone Injected 90 Min After Making an Axillary Block With Mepivacaine. A Prospective, Randomized, Placebo-controlled Study

Actual Study Start Date :

Apr 4, 2018

Actual Primary Completion Date :

Oct 15, 2018

Actual Study Completion Date :

Oct 16, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexamethasone Dexamethasone 8 mg/2cc I.V. 90 minutes after axillary block	Drug: 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.
Placebo Comparator: Normal saline Normal saline 2cc I.V., 90 minutes after axillary block	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.

Arm

Intervention/Treatment

Experimental: Dexamethasone

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

Drug: 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.

Placebo Comparator: Normal saline

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

Drug: Normal saline

Outcome Measures

Primary Outcome Measures

Duration of motor block [within 3 hours after intervention.]
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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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