Nerve BlockNCT03933566
US-Guided Superficial Cervical Plexus Block
An observational study of Nerve Block, run by Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine at 1 site in China.
Trial summary
This retrospective observational study compare ultrasound-guided plane and landmark-based superficial cervical plexus block Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nerve Block
- What is being tested?
- Ultrasound-Guided Superficial Cervical Plexus Block and Landmark-Based Superficial Cervical Plexus Block
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 1 Aug 2020
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 200
Who may be able to join
- Undergoing surgery of the shoulder and clavicle
- Urgent or planned surgery
Who cannot join
- Refused to sign informed consent
- Pregnant women
- Allergic to the local anesthetic
Trial locations and contacts
1 site in 1 country.
China1 site
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Cangzhou, Hebei, 061001
About this study
Official title: Comparison Between Ultrasound-Guided and Landmark-Based Superficial Cervical Plexus Block：A Retrospective Observational Study
This retrospective observational study compare ultrasound-guided plane and landmark-based superficial cervical plexus block
Read the detailed description
Traditionally, the superficial cervical plexus is blocked using a subcutaneous infiltration of local anesthetics along the posterior border of the sternocleidomastoid muscle.Recently, ultrasound has been used to identify intermuscular planes to carry out transversus abdominis plane and obturator nerve blocks.Thus, to validate this new method, the investigators conducted a retrospective observational study comparing ultrasound and the conventional landmark-based technique for superficial cervical plexus.
- Conditions
- Nerve Block
- Being tested
- Ultrasound-Guided Superficial Cervical Plexus Block, Landmark-Based Superficial Cervical Plexus Block
- Keywords
- Ultrasound-Guided Superficial Cervical Plexus Block, Landmark-Based Superficial Cervical Plexus Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Superficial Cervical Plexus BlockProcedure or surgery
Ultrasound-Guided Superficial Cervical Plexus Block
Landmark-Based Superficial Cervical Plexus BlockProcedure or surgery
Landmark-Based Superficial Cervical Plexus Block
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-Guided | Ultrasound-Guided Superficial Cervical Plexus Block Receives: Procedure: Ultrasound-Guided Superficial Cervical Plexus Block | |
| Landmark-Based | Landmark-Based Superficial Cervical Plexus Block Receives: Procedure: Landmark-Based Superficial Cervical Plexus Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
Number of Participants wit absence of pain sensation for all 4 branches of the superficial cervical plexus
Measured: At 15 mins after nerve block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start1 May 2019
- Primary completion1 Jun 2020
- Study completion1 Aug 2020
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruizhao Lv, M.D, Principal investigator, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933566
- Sponsor's protocol ID
- 2019CZTCWM2
- Status last verified
- Apr 2019
- First submitted
- 29 Dec 2017
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ultrasound-Guided and Landmark-Based Superficial Cervical Plexus Block：A Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT03933566
- Acronym / sponsor ID
- 2019CZTCWM2
- Conditions
- Nerve Block
- Keywords
- Ultrasound-Guided Superficial Cervical Plexus Block, Landmark-Based Superficial Cervical Plexus Block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cangzhou Hospital of Integrated Traditional Chinese and Western MedicineUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 1 May 2019 (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.
This retrospective observational study compare ultrasound-guided plane and landmark-based superficial cervical plexus block
Detailed description
Traditionally, the superficial cervical plexus is blocked using a subcutaneous infiltration of local anesthetics along the posterior border of the sternocleidomastoid muscle.Recently, ultrasound has been used to identify intermuscular planes to carry out transversus abdominis plane and obturator nerve blocks.Thus, to validate this new method, the investigators conducted a retrospective observational study comparing ultrasound and the conventional landmark-based technique for superficial cervical plexus.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-Guided | – | Procedure: Ultrasound-Guided Superficial Cervical Plexus BlockUltrasound-Guided Superficial Cervical Plexus Block |
| Landmark-Based | – | Procedure: Landmark-Based Superficial Cervical Plexus BlockLandmark-Based Superficial Cervical Plexus Block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 200
Key inclusion criteria (2 listed)
- Undergoing surgery of the shoulder and clavicle
- Urgent or planned surgery
Key exclusion criteria (3 listed)
- Refused to sign informed consent
- Pregnant women
- Allergic to the local anesthetic
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 |
|---|---|---|
| Ultrasound-Guided Superficial Cervical Plexus BlockUltrasound-Guided Superficial Cervical Plexus Block | Procedure or surgery | Ultrasound-Guided |
| Landmark-Based Superficial Cervical Plexus BlockLandmark-Based Superficial Cervical Plexus Block | Procedure or surgery | Landmark-Based |
Primary outcome
Success rate
Time frame: At 15 mins after nerve block
Number of Participants wit absence of pain sensation for all 4 branches of the superficial cervical plexus
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 9 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Ruizhao Lv, M.D principal investigator
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nerve Block, run by Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine 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 2 inclusion and 3 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 9 Apr 2024. 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?
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?
Success rate (time frame: At 15 mins after nerve block). 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 9 Apr 2024.