DexamethasonePhase 4NCT04763434
Dexamethasone and Dexmedetomidine as Adjuvants to Ropivacaine in Ultrasound-guided Multilevel Thoracic Paravertebral Block for Lobectomy: A Prospective, Randomized, Triple-blind Study
A Phase 4 study testing dexamethasone; dexmedetomidine; ropivacaine in people with Dexamethasone and Dexmedetomidine, run by Gansu Provincial Hospital.
Trial summary
The hypothesis is whether perineural dexamethasone and dexmedetomidine prolonged the duration of analgesia as compared with either perineural dexamethasone or perineural dexmedetomidine after TPVB. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Dexamethasone, Dexmedetomidine, Ropivacaine
- What is being tested?
- dexamethasone; dexmedetomidine; ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2021to 30 Aug 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ASA physical status I-II grade Undergoing elective lobectomy under general anesthesia. Participants aged from 16-65 years old.
Who cannot join
- Refusal for TPVB Inability to obtain informed consent Coagulation disorders, neuropathy, or body mass index greater than 40 kg/m2 Pregnancy Infections at the site of injection for the TPVB Allergy to dexamethasone; dexmedetomidine; ropivacaine Clinically significant cardiovascular, pulmonary, renal, or hepatic diseases
Trial locations and contacts
No sites are listed yet.
About this study
The hypothesis is whether perineural dexamethasone and dexmedetomidine prolonged the duration of analgesia as compared with either perineural dexamethasone or perineural dexmedetomidine after TPVB.
Read the detailed description
Design: A prospective, randomized, controlled study Setting: Single-center university hospital. Participants: The study included 90 patients undergoing lobectomy under general anesthesia.
Interventions: The patients were allocated randomly into the following 3 groups: 20 ml mixture of 37.5 mg ropivacaine with 5 mg dexamethasone (RS group) or 1 µg/kg dexmedetomidine (RM group), or with 1 µg/kg dexmedetomidine and 5 mg dexamethasone (RSM group). Ultrasound-guided TPVB was performed at 4 points-T4-5, T5-6, T6-7, and T7-8 of the surgical side; 5 mL of solution were injected at each point. Postoperatively, the PCIA was used as part of multimodal analgesia, and all patients recieve .
- Conditions
- Dexamethasone, Dexmedetomidine, Ropivacaine, Lobectomy
- Being tested
- dexamethasone; dexmedetomidine; ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasone; dexmedetomidine; ropivacaineDrug
Ultrasound-guided multilevelTPVB is performed at the end of lobectomy
| Study group | Role | What they receive |
|---|---|---|
| RS group | Active comparator | 20 ml mixture of 37.5 mg ropivacaine with 5 mg dexamethasone Receives: Drug: dexamethasone; dexmedetomidine; ropivacaine |
| RM group | Active comparator | 20 ml mixture of 37.5 mg ropivacaine with 1 µg/kg dexmedetomidine Receives: Drug: dexamethasone; dexmedetomidine; ropivacaine |
| RSM group | Experimental | 20 ml mixture of 37.5 mg ropivacaine with 1 µg/kg dexmedetomidine and 5 mg dexamethasone (RSM group) Receives: Drug: dexamethasone; dexmedetomidine; ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the duration of analgesia
time from completion of TPVB operation to VAS more than 3
Measured: 48 hours after surgery
Secondary outcomes (3)
total sufentanil consumption
Measured: 48 hours after surgery
VAS
VAS at rest and during coughing are evaluated by a blinded observer postoperatively
Measured: 1, 2, 4, 8, 12, 24, 36, and 48 hours after surgery
adverse effects
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start20 Mar 2021 (estimated)
- Primary completion20 Aug 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexamethasoneStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gansu Provincial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dong zhang, Gansu Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763434
- Sponsor's protocol ID
- GanSu provincial hospital
- Status last verified
- Feb 2021
- First submitted
- 17 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone and Dexmedetomidine as Adjuvants to Ropivacaine in Ultrasound-guided Multilevel Thoracic Paravertebral Block for Lobectomy: A Prospective, Randomized, Triple-blind Study
- ClinicalTrials.gov ID
- NCT04763434
- Acronym / sponsor ID
- GanSu provincial hospital
- Conditions
- Dexamethasone, Dexmedetomidine, Ropivacaine, Lobectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Gansu Provincial HospitalUniversity, hospital or other
- Study start
- 20 Mar 2021 (estimated)
- Primary completion
- 20 Aug 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 21 Feb 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.
The hypothesis is whether perineural dexamethasone and dexmedetomidine prolonged the duration of analgesia as compared with either perineural dexamethasone or perineural dexmedetomidine after TPVB.
Detailed description
Design: A prospective, randomized, controlled study Setting: Single-center university hospital. Participants: The study included 90 patients undergoing lobectomy under general anesthesia.
Interventions: The patients were allocated randomly into the following 3 groups: 20 ml mixture of 37.5 mg ropivacaine with 5 mg dexamethasone (RS group) or 1 µg/kg dexmedetomidine (RM group), or with 1 µg/kg dexmedetomidine and 5 mg dexamethasone (RSM group). Ultrasound-guided TPVB was performed at 4 points-T4-5, T5-6, T6-7, and T7-8 of the surgical side; 5 mL of solution were injected at each point. Postoperatively, the PCIA was used as part of multimodal analgesia, and all patients recieve .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RS group | Active comparator | Drug: dexamethasone; dexmedetomidine; ropivacaine20 ml mixture of 37.5 mg ropivacaine with 5 mg dexamethasone |
| RM group | Active comparator | Drug: dexamethasone; dexmedetomidine; ropivacaine20 ml mixture of 37.5 mg ropivacaine with 1 µg/kg dexmedetomidine |
| RSM group | Experimental | Drug: dexamethasone; dexmedetomidine; ropivacaine20 ml mixture of 37.5 mg ropivacaine with 1 µg/kg dexmedetomidine and 5 mg dexamethasone (RSM group) |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ASA physical status I-II grade Undergoing elective lobectomy under general anesthesia. Participants aged from 16-65 years old.
Key exclusion criteria (1 listed)
- Refusal for TPVB Inability to obtain informed consent Coagulation disorders, neuropathy, or body mass index greater than 40 kg/m2 Pregnancy Infections at the site of injection for the TPVB Allergy to dexamethasone; dexmedetomidine; ropivacaine Clinically significant cardiovascular, pulmonary, renal, or hepatic diseases
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 |
|---|---|---|
| dexamethasone; dexmedetomidine; ropivacaineUltrasound-guided multilevelTPVB is performed at the end of lobectomy | Drug | RM group, RS group, RSM group |
Primary outcome
the duration of analgesia
Time frame: 48 hours after surgery
time from completion of TPVB operation to VAS more than 3
3 secondary outcomes
total sufentanil consumption
Time frame: 48 hours after surgery
VAS
Time frame: 1, 2, 4, 8, 12, 24, 36, and 48 hours after surgery
adverse effects
Time frame: 48 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexamethasone; dexmedetomidine; ropivacaine in people with Dexamethasone and Dexmedetomidine, run by Gansu Provincial Hospital.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wen jun yan, doctor (17361552758, yanwj2008@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the duration of analgesia (time frame: 48 hours after surgery). 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 21 Feb 2021.