Impact on Sensitivity and Motor Block Duration of an Intravenous Dexamethasone an Axillary Block With Mepivacaine. (DEXA-rescue)
Primary Purpose
Hand Wound, Wrist Wound, Forearm Wound
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Dexamethasone
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Hand Wound focused on measuring Axillary block, Dexamethasone, anesthesia
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
Sites / Locations
- Avicenne
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dexamethasone
Normal saline
Arm Description
Dexamethasone 8 mg/2cc I.V. 90 minutes after axillary block
Normal saline 2cc I.V., 90 minutes after axillary block
Outcomes
Primary Outcome Measures
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
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.
Sedation or general anesthesia request
Pain scores in recovering room
Adverse effects in next 24 hours
Full Information
NCT ID
NCT03555929
First Posted
March 16, 2018
Last Updated
June 18, 2019
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT03555929
Brief Title
Impact on Sensitivity and Motor Block Duration of an Intravenous Dexamethasone an Axillary Block With Mepivacaine.
Acronym
DEXA-rescue
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 4, 2018 (Actual)
Primary Completion Date
October 15, 2018 (Actual)
Study Completion Date
October 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Wound, Wrist Wound, Forearm Wound, Hand Fracture, Wrist Fracture, Forearm Fracture
Keywords
Axillary block, Dexamethasone, anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
Dexamethasone 8 mg/2cc I.V. 90 minutes after axillary block
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Normal saline 2cc I.V., 90 minutes after axillary block
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
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
Intervention Name(s)
Normal saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Duration of motor block
Description
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
Time Frame
within 3 hours after intervention.
Secondary Outcome Measure Information:
Title
Duration of sensitivity block defined as the time between the performance of sensitivity block and appearance of paresthesic or the first analgesia request.
Time Frame
within 3 hours (for outcome measure 1) (end of intervention for 2 and 3) and at 24 hours after the intervention
Title
Sedation or general anesthesia request
Time Frame
within 3 hours (for outcome measure 1) (end of intervention for 2 and 3) and at 24 hours after the intervention
Title
Pain scores in recovering room
Time Frame
within 3 hours (for outcome measure 1) (end of intervention for 2 and 3) and at 24 hours after the intervention
Title
Adverse effects in next 24 hours
Time Frame
within 3 hours (for outcome measure 1) (end of intervention for 2 and 3) and at 24 hours after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Avicenne
City
Bobigny
ZIP/Postal Code
93000
Country
France
12. IPD Sharing Statement
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Impact on Sensitivity and Motor Block Duration of an Intravenous Dexamethasone an Axillary Block With Mepivacaine.
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