Nerve BlockNCT05556122
Efficacy of Compound Betamethasone Injection Combined With Ropivacaine in Ultrasound-guided Intercostal Nerve Block for Chronic Post-thoracotomy Pain
A study testing intercostal nerve block, lateral intercostal nerve block and ropivacaine + compound betamethasone in people with Nerve Block, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
The patients were divided into two groups by random number method: GroupRD1 group and GroupRD2 group were given general anesthesia and intercostal nerve block.The drug for intercostal nerve block was 0.33% ropivacaine +2.333mg compound betamethasone (1.667mg betamethasone dipropionate + 0.667mg betamethasone sodium… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nerve Block
- What is being tested?
- intercostal nerve block, lateral intercostal nerve block and ropivacaine + compound betamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2022to 30 Dec 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years old
- ASA grade I-III
- BMI: 18.5-28kg/m2
- Type of surgery: elective thoracoscopic lung mass resection
- Informed consent has been signed by the patient and/or family members
Who cannot join
- game anesthesia or sugar cortical hormone drugs allergic
- preoperative use of opioid medicines
- serious blood coagulation dysfunction
- serious heart, lung, liver and renal insufficiency
- put, chemotherapy, and glucocorticoid immunosuppressive therapy history or diseases of the immune system
- peptic ulcer
Show all 10Show fewer
- newly gastrointestinal surgery
- has a history of thoracic surgery
- is the central nervous system disease
- Other glucocorticoids should be used with caution in patients such as fractures, wound repair, corneal ulcers, hyperadrenocortical disease, diabetes mellitus, pregnant women, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
YiBinQin
Nantong, Jiangsu, 226001
DingYing Ge, 19851303726, 1340746053@qq.com
About this study
Official title: Efficacy of Compound Betamethasone Injection Combined With Ropivacaine in Ultrasound-guided Slit Intercostals Nerve Block for Chronic Post-thoracotomy Pain:A Single Blind Randomized Control Trial
The patients were divided into two groups by random number method: GroupRD1 group and GroupRD2 group were given general anesthesia and intercostal nerve block.The drug for intercostal nerve block was 0.33% ropivacaine +2.333mg compound betamethasone (1.667mg betamethasone dipropionate + 0.667mg betamethasone sodium phosphate) to 15ml.
Read the detailed description
The RD1 group received ultrasound-guided intercostal nerve block at the incision before anesthesia induction, and the RD2 group received ultrasound-guided intercostal nerve block at the lateral costal Angle before anesthesia induction.
- Conditions
- Nerve Block
- Being tested
- intercostal nerve block, lateral intercostal nerve block, ropivacaine + compound betamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intercostal nerve blockOther
General anesthesia and intercostal nerve block were performed. The drug for intercostal nerve block was 0.33% ropivacaine +2.333mg compound betamethasone (1.667mg betamethasone dipropionate + 0.667mg betamethasone sodium phosphate) to 15ml
lateral intercostal nerve blockOther
lateral intercostal nerve block
ropivacaine + compound betamethasoneDrug
The drug for intercostal nerve block was 0.33% ropivacaine +2.333mg compound betamethasone (1.667mg betamethasone dipropionate + 0.667mg betamethasone sodium phosphate) to 15ml
| Study group | Role | What they receive |
|---|---|---|
| intercostal nerve block at the incision | Experimental | General anesthesia and intercostal nerve block were performed.The drug for intercostal nerve block was 0.33% ropivacaine +2.333mg compound betamethasone (1.667mg betamethasone dipropionate + 0.667mg betamethasone sodium phosphate) to 15ml Receives: Other: intercostal nerve block; Drug: ropivacaine + compound betamethasone |
| lateral intercostal nerve block at costal angle | Active comparator | General anesthesia and intercostal nerve block were performed.The drug for intercostal nerve block was 0.33% ropivacaine +2.333mg compound betamethasone (1.667mg betamethasone dipropionate + 0.667mg betamethasone sodium phosphate) to 15ml Receives: Other: lateral intercostal nerve block; Drug: ropivacaine + compound betamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute and chronic postoperative pain
Numeric rating scale(NRS) is used to assess acute postoperative pain
Measured: 6 hours after surgery
Acute and chronic postoperative pain
Numeric rating scale(NRS) is used to assess acute postoperative pain
Measured: 24 hours after surgery
Acute and chronic postoperative pain
Numeric rating scale(NRS) is used to assess acute postoperative pain
Measured: 48 hours after surgery
Acute and chronic postoperative pain
Numeric rating scale(NRS) is used to assess acute postoperative pain
Measured: 1 months after surgery
Acute and chronic postoperative pain
Numeric rating scale(NRS) is used to assess acute postoperative pain
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start4 Jul 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yibin Qin, Affiliated Hospital of Nantong University
- Investigators
- DingYing Ge, Study director, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556122
- Sponsor's protocol ID
- 2022-K107-01
- Status last verified
- Sep 2022
- First submitted
- 19 Sep 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Compound Betamethasone Injection Combined With Ropivacaine in Ultrasound-guided Slit Intercostals Nerve Block for Chronic Post-thoracotomy Pain:A Single Blind Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05556122
- Acronym / sponsor ID
- 2022-K107-01
- Conditions
- Nerve Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 27 Sep 2022 (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 patients were divided into two groups by random number method: GroupRD1 group and GroupRD2 group were given general anesthesia and intercostal nerve block.The drug for intercostal nerve block was 0.33% ropivacaine +2.333mg compound betamethasone (1.667mg betamethasone dipropionate + 0.667mg betamethasone sodium phosphate) to 15ml.
Detailed description
The RD1 group received ultrasound-guided intercostal nerve block at the incision before anesthesia induction, and the RD2 group received ultrasound-guided intercostal nerve block at the lateral costal Angle before anesthesia induction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intercostal nerve block at the incision | Experimental | Other: intercostal nerve block, Drug: ropivacaine + compound betamethasoneGeneral anesthesia and intercostal nerve block were performed.The drug for intercostal nerve block was 0.33% ropivacaine +2.333mg compound betamethasone (1.667mg betamethasone dipropionate + 0.667mg betamethasone sodium phosphate) to 15ml |
| lateral intercostal nerve block at costal angle | Active comparator | Other: lateral intercostal nerve block, Drug: ropivacaine + compound betamethasoneGeneral anesthesia and intercostal nerve block were performed.The drug for intercostal nerve block was 0.33% ropivacaine +2.333mg compound betamethasone (1.667mg betamethasone dipropionate + 0.667mg betamethasone sodium phosphate) to 15ml |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-70 years old
- ASA grade I-III
- BMI: 18.5-28kg/m2
- Type of surgery: elective thoracoscopic lung mass resection
- Informed consent has been signed by the patient and/or family members
Key exclusion criteria (10 listed)
- game anesthesia or sugar cortical hormone drugs allergic
- preoperative use of opioid medicines
- serious blood coagulation dysfunction
- serious heart, lung, liver and renal insufficiency
- put, chemotherapy, and glucocorticoid immunosuppressive therapy history or diseases of the immune system
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 |
|---|---|---|
| intercostal nerve blockGeneral anesthesia and intercostal nerve block were performed. The drug for intercostal nerve block was 0.33% ropivacaine +2.333mg compound betamethasone (1.667mg betamethasone dipropionate + 0.667mg betamethasone sodium phosphate) to 15ml | Other | intercostal nerve block at the incision |
| lateral intercostal nerve blocklateral intercostal nerve block | Other | lateral intercostal nerve block at costal angle |
| ropivacaine + compound betamethasoneThe drug for intercostal nerve block was 0.33% ropivacaine +2.333mg compound betamethasone (1.667mg betamethasone dipropionate + 0.667mg betamethasone sodium phosphate) to 15ml | Drug | intercostal nerve block at the incision, lateral intercostal nerve block at costal angle |
Primary outcome
Acute and chronic postoperative pain
Time frame: 6 hours after surgery
Numeric rating scale(NRS) is used to assess acute postoperative pain
Acute and chronic postoperative pain
Time frame: 24 hours after surgery
Numeric rating scale(NRS) is used to assess acute postoperative pain
Acute and chronic postoperative pain
Time frame: 48 hours after surgery
Numeric rating scale(NRS) is used to assess acute postoperative pain
Acute and chronic postoperative pain
Time frame: 1 months after surgery
Numeric rating scale(NRS) is used to assess acute postoperative pain
Acute and chronic postoperative pain
Time frame: 3 months after surgery
Numeric rating scale(NRS) is used to assess acute postoperative pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
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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.
DingYing Ge study director
Affiliated Hospital of Nantong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intercostal nerve block, lateral intercostal nerve block and ropivacaine + compound betamethasone in people with Nerve Block, run by Affiliated Hospital of Nantong University 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 5 inclusion and 10 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 27 Sep 2022. 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.
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 YiBin Qin (13815212600, 572537172@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute and chronic postoperative pain (time frame: 6 hours after surgery). The study lists 5 primary outcomes in all. 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 27 Sep 2022.