AnalgesiaPhase 4NCT04714112
Low-dose Intravenous Dexamethasone at Different Times as Adjunvants for Brachial Plexus Blocks
A Phase 4 study testing dexamethasone in people with Analgesia and Dexamethasone, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital at 1 site in China.
Trial summary
Dexamethasone has been tested as an effective adjuvant to prolong the effect of local anesthetics for peripheral nerve blocks, both perineurally and intravenously. The purpose of this study is to investigate the effect of the addition of dexamethasone (5mg) at different time to a standard ropivacaine solution (0.5%)… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia, Dexamethasone, Brachial Plexus Block
- What is being tested?
- dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2021to 31 Jul 2021
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing arthroscopic shoulder surgery at Shanghai Sixth People's Hospital.
- ASA functional status class I to II
- Age 18 to 70 years
- BMI ≤ 35 kg/m2
Who cannot join
- Lack of patient consent
- Allergy to dexamethasone or ropivacaine
- BMI > 35 kg/m2
- Contraindications to low dose dexamethasone including peptic ulcer disease, systemic infection, glaucoma, active varicella/herpetic infections, diabetes mellitus
- Contraindications to ISB including severe Chronic Obstructive Pulmonary Disease (Forced expiratory volume < 40% predicted), coagulopathy, pre-existing neurologic deficit in ipsilateral upper extremity, localized infection
- Pregnant or nursing females
- Chronic opioid use defined as > 30mg oral morphine or equivalent per day
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiaotong University affiliated Shanghai Sixth People's Hospital
Shanghai
About this study
Official title: Comparison of the Effects of Different Time of Intravenous Dexamethasone on Brachial Plexus Block: a Randomized Control Study
Dexamethasone has been tested as an effective adjuvant to prolong the effect of local anesthetics for peripheral nerve blocks, both perineurally and intravenously. The purpose of this study is to investigate the effect of the addition of dexamethasone (5mg) at different time to a standard ropivacaine solution (0.5%) on analgesic duration of interscalene block.
Read the detailed description
Interscalene brachial plexus block (ISB) is regarded as the standard of care for anesthesia and analgesia for shoulder surgery by providing the superior analgesia and reducing opioid consumption. After several hours when the effects of single injection ISB wear off, the patients often suffer moderate to severe pain of the surgical insult and required strong opioid analgesia. Efforts to prolong ISB duration by adding adjuvants to local anesthetic (eg. clonidine, dexmedetomidine) have been studied with promising results. Dexamethasone, has been added to local anesthetic solutions for ISB and has demonstrated promise in preliminary studies. Perineural dexamethasone (8-10mg) in conjunction with local anesthetic prolongs the duration of ISB with an effect sizes ranging from 40% to 75% (absolute effect ~ 6 to 10 hours). Dexamethasone, however, is only approved for intramuscular or intravenous administration and therefore perineural use is currently off-label. Intravenous administration of dexamethasone was reported to have similar effects as perineural route indicating the possible mechanism for prolonging analgesic duration might be due to the systemic effects of dexamethasone. We hypothesized: should that is the reason, systemic administration of dexamethasone at different time may provide similar effects on the duration of peripheral nerve block. Dexamethasone is a slow effect cortisone with long half-time, it is widely used at the beginning of surgery to prevent postoperative nausea and vomiting. A trial that demonstrates enhanced block quality and duration associated with intravenous dexamethasone at different time may allow us to achieve prolonged duration of effect if dexamethasone is used in perioperative period for different purpose. This would further identify the possible mechanism of dexamethasone to prolong the analgesia effect of local anesthetics.
- Conditions
- Analgesia, Dexamethasone, Brachial Plexus Block, Intravenous Drug Usage, Time, Shoulder Surgery
- Being tested
- dexamethasone
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasoneDrug
Also called Dexamethasone Dexamethasone sodium phosphate
Intravenous administration of dexamethasone at different time for the duration of ISB with 0.5% ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| preoperative group | Experimental | Intravenous dexamethasone (5mg) is used when ultrasound guided ISB is performed. Receives: Drug: dexamethasone |
| postoperative group | Active comparator | Ultasound guided ISB is performed before operation and intravenous dexamethasone (5mg) is used in postoperative care unit ( PACU) Receives: Drug: dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of sensory block
from completion of ISB to VAS for pain > 0 ( in hours)
Measured: one day postoperative
Secondary outcomes (7)
Time to First Opioid Consumption
Time from completion of block procedure to first consumption of opioid analgesic (in hours)
Measured: one day postoperative
Opioid Consumption
Opioid consumption (in oral morphine equivalents) will be recorded at 12 hours, 24 hours and 48 hours
Measured: two days postoperative
Visual Analog Scale for pain ( from 0 to 10 )
Recorded at 12 hours, 24 hours, and 7 days 0 is no pain, 10 is the worst pain imaginable. Lower number is better.
Measured: 7 days postoperative
Postoperative Serum Blood Glucose
Measured on the morning of first day after surgery
Measured: one day postoperative
Infection
Number of participants with localized infection at nerve block site
Measured: 7 days postoperative
Number of Participants With Postoperative Nausea and/or Vomiting
Number of participants with postoperative nausea and/or vomiting assessed at 12 hours, 24, hours, and 7 days postoperatively
Measured: 7 days postoperative
Number of Participants With Nerve Damage From Interscalene Block
Persistent paresthesia, and sensory/motor block at 7 days
Measured: 7 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start10 Jan 2021
- Primary completion31 May 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quanhong Zhou, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Investigators
- Quanhong Zhou, MD., Ph.D, Principal investigator, Shanghai Jiaotong University affiliated Shanghai Sixth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714112
- Sponsor's protocol ID
- 2020-186
- Status last verified
- Jan 2023
- First submitted
- 15 Jan 2021
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Different Time of Intravenous Dexamethasone on Brachial Plexus Block: a Randomized Control Study
- ClinicalTrials.gov ID
- NCT04714112
- Acronym / sponsor ID
- 2020-186
- Conditions
- Analgesia, Dexamethasone, Brachial Plexus Block, Intravenous Drug Usage, Time, Shoulder Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's HospitalUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 19 Jan 2021 (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.
Dexamethasone has been tested as an effective adjuvant to prolong the effect of local anesthetics for peripheral nerve blocks, both perineurally and intravenously. The purpose of this study is to investigate the effect of the addition of dexamethasone (5mg) at different time to a standard ropivacaine solution (0.5%) on analgesic duration of interscalene block.
Detailed description
Interscalene brachial plexus block (ISB) is regarded as the standard of care for anesthesia and analgesia for shoulder surgery by providing the superior analgesia and reducing opioid consumption. After several hours when the effects of single injection ISB wear off, the patients often suffer moderate to severe pain of the surgical insult and required strong opioid analgesia. Efforts to prolong ISB duration by adding adjuvants to local anesthetic (eg. clonidine, dexmedetomidine) have been studied with promising results. Dexamethasone, has been added to local anesthetic solutions for ISB and has demonstrated promise in preliminary studies. Perineural dexamethasone (8-10mg) in conjunction with local anesthetic prolongs the duration of ISB with an effect sizes ranging from 40% to 75% (absolute effect ~ 6 to 10 hours). Dexamethasone, however, is only approved for intramuscular or intravenous administration and therefore perineural use is currently off-label. Intravenous administration of dexamethasone was reported to have similar effects as perineural route indicating the possible mechanism for prolonging analgesic duration might be due to the systemic effects of dexamethasone. We hypothesized: should that is the reason, systemic administration of dexamethasone at different time may provide similar effects on the duration of peripheral nerve block. Dexamethasone is a slow effect cortisone with long half-time, it is widely used at the beginning of surgery to prevent postoperative nausea and vomiting. A trial that demonstrates enhanced block quality and duration associated with intravenous dexamethasone at different time may allow us to achieve prolonged duration of effect if dexamethasone is used in perioperative period for different purpose. This would further identify the possible mechanism of dexamethasone to prolong the analgesia effect of local anesthetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preoperative group | Experimental | Drug: dexamethasoneIntravenous dexamethasone (5mg) is used when ultrasound guided ISB is performed. |
| postoperative group | Active comparator | Drug: dexamethasoneUltasound guided ISB is performed before operation and intravenous dexamethasone (5mg) is used in postoperative care unit ( PACU) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing arthroscopic shoulder surgery at Shanghai Sixth People's Hospital.
- ASA functional status class I to II
- Age 18 to 70 years
- BMI ≤ 35 kg/m2
Key exclusion criteria (7 listed)
- Lack of patient consent
- Allergy to dexamethasone or ropivacaine
- BMI > 35 kg/m2
- Contraindications to low dose dexamethasone including peptic ulcer disease, systemic infection, glaucoma, active varicella/herpetic infections, diabetes mellitus
- Contraindications to ISB including severe Chronic Obstructive Pulmonary Disease (Forced expiratory volume < 40% predicted), coagulopathy, pre-existing neurologic deficit in ipsilateral upper extremity, localized infection
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 |
|---|---|---|
| dexamethasoneAlso: Dexamethasone Dexamethasone sodium phosphateIntravenous administration of dexamethasone at different time for the duration of ISB with 0.5% ropivacaine | Drug | postoperative group, preoperative group |
Primary outcome
Duration of sensory block
Time frame: one day postoperative
from completion of ISB to VAS for pain > 0 ( in hours)
7 secondary outcomes
Time to First Opioid Consumption
Time frame: one day postoperative
Opioid Consumption
Time frame: two days postoperative
Visual Analog Scale for pain ( from 0 to 10 )
Time frame: 7 days postoperative
Postoperative Serum Blood Glucose
Time frame: one day postoperative
Infection
Time frame: 7 days postoperative
Number of Participants With Postoperative Nausea and/or Vomiting
Time frame: 7 days postoperative
Number of Participants With Nerve Damage From Interscalene Block
Time frame: 7 days postoperative
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 26 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Quanhong Zhou, MD., Ph.D principal investigator
Shanghai Jiaotong University affiliated Shanghai Sixth People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexamethasone in people with Analgesia and Dexamethasone, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital at 1 site in China.
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 4 inclusion and 7 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 26 Jan 2023. 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 China. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 sensory block (time frame: one day postoperative). 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 26 Jan 2023.