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出境医 / 临床实验 / Analgesia for Clavicular Fracture and Surgery
Analgesia for Clavicular Fracture and Surgery
Study Description
Brief Summary:
Compared efficacy of ultrasound-guided combined interscalene-cervical plexus versus combined supraclavicular-cervical plexus block for surgical anesthesia in clavicular fractures.
| Condition or disease | Intervention/treatment |
|---|---|
| Clavicular Fractures | Procedure: Interscalene-Cervical Plexus Block Procedure: Supraclavicular-Cervical Plexus Block |
Detailed Description:
The primary objective of this study was to compare the effectiveness of ultrasound-guided combined interscalene-cervical plexus versus combined supraclavicular-cervical plexus block for surgical anesthesia in clavicular fractures.The hypothesis of this study was that the supraclavicular-cervical plexus block could provide better anesthesia with less anesthesia related complications.
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 150 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Ultrasound-Guided Combined Interscalene-Cervical Plexus Versus Combined Supraclavicular-Cervical Plexus Block for Surgical Anesthesia in Clavicular Fractures: A Retrospective Observational Study |
| Estimated Study Start Date : | May 1, 2019 |
| Estimated Primary Completion Date : | December 1, 2021 |
| Estimated Study Completion Date : | March 1, 2022 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
Interscalene-Cervical Plexus Block
Ultrasound-Guided Combined Interscalene-Cervical Plexus Block
|
Procedure: Interscalene-Cervical Plexus Block
Ultrasound-Guided Combined Interscalene-Cervical Plexus Block
|
|
Supraclavicular-Cervical Plexus Block
Ultrasound-Guided Combined Supraclavicular-Cervical Plexus Block
|
Procedure: Supraclavicular-Cervical Plexus Block
Ultrasound-Guided Combined Supraclavicular-Cervical Plexus Block
|
Outcome Measures
Primary Outcome Measures :
- Block success rate [ Time Frame: At time 15 minutes after the block ]Sensory blockade was assessed using the pinprick test at the surgery site
Secondary Outcome Measures :
- Acute complications [ Time Frame: At the end of surgery immediately ]Number of participants with phrenic nerve palsy
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
150
Criteria
Inclusion Criteria:
- Surgery of the clavicular fractures under combined cervical plexus plus brachial plexus block
- Urgent or planned surgery
Exclusion Criteria:
- Refused to sign informed consent
- Pregnant women
- Allergic to the local anesthetic
Contacts and Locations
Contacts
| Contact: Ruizhao Lv, M.D | +86-17772657375 | lvruizhao@hotmail.com |
Locations
| China, Hebei | |
| Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine | |
| Cangzhou, Hebei, China, 061001 | |
Sponsors and Collaborators
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Investigators
| Principal Investigator: | Ruizhao Lv, M.D | Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | April 28, 2019 | ||||
| First Posted Date | May 1, 2019 | ||||
| Last Update Posted Date | May 9, 2019 | ||||
| Estimated Study Start Date | May 1, 2019 | ||||
| Estimated Primary Completion Date | December 1, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Block success rate [ Time Frame: At time 15 minutes after the block ] Sensory blockade was assessed using the pinprick test at the surgery site
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
Acute complications [ Time Frame: At the end of surgery immediately ] Number of participants with phrenic nerve palsy
|
||||
| Original Secondary Outcome Measures |
Acute complications [ Time Frame: At the end of surgery immediately ] Phrenic nerve palsy
|
||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Analgesia for Clavicular Fracture and Surgery | ||||
| Official Title | Ultrasound-Guided Combined Interscalene-Cervical Plexus Versus Combined Supraclavicular-Cervical Plexus Block for Surgical Anesthesia in Clavicular Fractures: A Retrospective Observational Study | ||||
| Brief Summary | Compared efficacy of ultrasound-guided combined interscalene-cervical plexus versus combined supraclavicular-cervical plexus block for surgical anesthesia in clavicular fractures. | ||||
| Detailed Description | The primary objective of this study was to compare the effectiveness of ultrasound-guided combined interscalene-cervical plexus versus combined supraclavicular-cervical plexus block for surgical anesthesia in clavicular fractures.The hypothesis of this study was that the supraclavicular-cervical plexus block could provide better anesthesia with less anesthesia related complications. | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | 150 | ||||
| Condition | Clavicular Fractures | ||||
| Intervention |
|
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| Study Groups/Cohorts |
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Not yet recruiting | ||||
| Estimated Enrollment |
150 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | March 1, 2022 | ||||
| Estimated Primary Completion Date | December 1, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender |
|
||||
| Ages | 18 Years to 65 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts |
|
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| Listed Location Countries | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03933228 | ||||
| Other Study ID Numbers | 2019CZTCWM4 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine | ||||
| Study Sponsor | Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine | ||||
| Collaborators | Not Provided | ||||
| Investigators |
|
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| PRS Account | Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine | ||||
| Verification Date | April 2019 | ||||
