Hand WoundPhase 3DEXA-rescueNCT03555929
Impact on Sensitivity and Motor Block Duration of an Intravenous Dexamethasone an Axillary Block With Mepivacaine.
A Phase 3 study testing Dexamethasone and Normal saline in people with Hand Wound and Wrist Wound, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Wound, Wrist Wound, Forearm Wound
- What is being tested?
- Dexamethasone and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2018to 16 Oct 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Hand Wound, Wrist Wound, Forearm Wound, Hand Fracture, Wrist Fracture, Forearm Fracture
- Being tested
- Dexamethasone, Normal saline
- Keywords
- Axillary block, Dexamethasone, anesthesia
- Medical subject headings
- Hand Injuries, Wrist Injuries, Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
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 salineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Dexamethasone 8 mg/2cc I.V. 90 minutes after axillary block Receives: Drug: Dexamethasone |
| Normal saline | Placebo comparator | Normal saline 2cc I.V., 90 minutes after axillary block Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: within 3 hours (for outcome measure 1) (end of intervention for 2 and 3) and at 24 hours after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start4 Apr 2018
- Primary completion15 Oct 2018
- Study completion16 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand WoundStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555929
- Sponsor's protocol ID
- P170701J
- Other IDs
- 2017-004164-35, 2017
- Acronym
- DEXA-rescue
- Status last verified
- Mar 2018
- First submitted
- 16 Mar 2018
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03555929
- Acronym / sponsor ID
- DEXA-rescue / P170701J
- Conditions
- Hand Wound, Wrist Wound, Forearm Wound, Hand Fracture, Wrist Fracture, Forearm Fracture
- Keywords
- Axillary block, Dexamethasone, anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 16 Oct 2018 (actual)
- First posted
- 14 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: DexamethasoneDexamethasone 8 mg/2cc I.V. 90 minutes after axillary block |
| Normal saline | Placebo comparator | Drug: Normal salineNormal saline 2cc I.V., 90 minutes after axillary block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone80 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. | Drug | Dexamethasone |
| Normal saline80 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. | Drug | Normal saline |
Primary outcome
Duration of motor block
Time frame: 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
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone and Normal saline in people with Hand Wound and Wrist Wound, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of motor block (time frame: within 3 hours after intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019.