Proximal Humeral FractureNCT03919422
Paravertebral Block for Proximal Humeral Fracture Surgery
A study testing T2 paravertebral block and interscalene brachial plexus block and superficial cervical plexus block in people with Proximal Humeral Fracture, run by Shanghai 6th People's Hospital at 1 site in China.
Trial summary
This study evaluates the effects of T2 paravertebral block block improving interscalene brachial plexus block and superficial cervical plexus block on the relief of pain intensity during elderly proximal humerus fracture fixation surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Proximal Humeral Fracture
- What is being tested?
- T2 paravertebral block and interscalene brachial plexus block and superficial cervical plexus block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2019to 26 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Participant age≥ 65 years
- Body mass index (BMI) < 30kg/m2
- American Society of Anesthesiologists (ASA) classification I-II
- Anterior operative incision approach
Who cannot join
- Request for general anesthesia
- Nerve block is unable to be performed due to various reasons
- Coagulation dysfunction or anticoagulation therapy
- History of upper limb nerve injury or phrenic nerve injury
- Multiple trauma
- Uncontrolled respiratory disease (severe chronic obstructive pulmonary disease, asthma, pulmonary infection, pneumothorax, etc.)
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- Uncontrolled hypertension (systolic pressure over 180mmHg or diastolic pressure over 110mmHg)
- Uncontrolled heart disease (coronary heart disease, valvular disease or arrhythmia, etc.)
- Stroke or cognitive dysfunction (unable to communicate or cooperate)
- Hypersensitivity or allergy to anesthetics (ropivacaine or remifentanil)
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
About this study
Official title: Effectiveness of Additional Thoracic Paravertebral Block in Improving Anesthetic Effects of Regional Anesthesia for Proximal Humeral Fracture Surgery in Elderly Patients: Study Protocol for a Randomized Controlled Trial
This study evaluates the effects of T2 paravertebral block block improving interscalene brachial plexus block and superficial cervical plexus block on the relief of pain intensity during elderly proximal humerus fracture fixation surgery. The brachial plexus and cervical plexus block(IC block) will be performed in half of participants, while the T2 paravertebral block combined with IC block will be performed in the other half.
- Conditions
- Proximal Humeral Fracture
- Being tested
- T2 paravertebral block, interscalene brachial plexus block and superficial cervical plexus block
- Keywords
- thoracic paravertebral block, regional anesthesia, elderly, proximal humeral fracture, brachial plexus block, cervical plexus block, intercostobrachial nerve
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T2 paravertebral blockProcedure or surgery
Also called T2 PVB(paravertebral blockade )
Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin).
interscalene brachial plexus block and superficial cervical plexus blockProcedure or surgery
Also called IC block
An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
| Study group | Role | What they receive |
|---|---|---|
| IC group | Active comparator | Interscalene brachial plexus-Cervical plexus Receives: Procedure: interscalene brachial plexus block and superficial cervical plexus block |
| ICTP group | Experimental | Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade Receives: Procedure: T2 paravertebral block; Procedure: interscalene brachial plexus block and superficial cervical plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate(Ability to Proceed With Surgery Without the Need for Intravenous Narcotics, General Anaesthesia, Rescue Blocks or Local Infiltration by the Surgeon)
Success rate - was equivalent to surgical anesthesia, defined as the ability to proceed with surgery without the need for intravenous narcotics, general anaesthesia, rescue blocks or local infiltration by the surgeon.
Measured: throughout the operation duration, an average of 2 to 3 hours
Secondary outcomes (7)
Assessment of Sensory Blockade
Sensory blockade graded from 0 to 2(0= normal sensation, 1= decreased sensation and 2= no perception) by applying pinprick and cold test to the different parts of shoulder
Measured: 20 minutes after all the nerve block operations have been finished
Proportion of Participants Completed the Procedure With Remifentanil
When the primary outcome of the participant is assessed by "failure" during the surgery, 0.25μg/kg/min remifentanil will be given via intravenous infusion. Two minutes later, the procedure will continue if the participant can tolerate the pain.
Measured: throughout the operation duration, an average of 2 to 3 hours
Proportion of Participants Conversed Into General Anesthesia(Laryngeal Mask Airway,LMA)
When the primary outcome of the participant is assessed by "failure" during the surgery, 0.25μg/kg/min remifentanil will be given via intravenous infusion. Two minutes later, if the participant cannot tolerate the pain, a general anesthesia with LMA will be given.
Measured: throughout the operation duration, an average of 2 to 3 hours
Cumulative Doses of Intraoperative Vasoactive Medications (Urapidil,Atropine, Ephedrine)
Cumulative doses of vasoactive drugs required such as urapidil,atropine, ephedrine during the surgery.
Measured: At the end of surgical procedure(an average of 2 to 3 hours)
Cumulative Doses of Intraoperative Vasoactive Medications (Deoxyepinephrine)
Cumulative doses of intravenous deoxyepinephrine required during the surgery.
Measured: At the end of surgical procedure(an average of 2 to 3 hours)
Complications Related With Anesthesia
Presence or absence of local anesthetic systemic toxicity, pneumothorax, and epidural block, total spinal block, hematoma
Measured: within 24 hours since the nerve block finished
Intraoperative Adverse Reactions (Including Hypertension, Hypotension, Bradycardia, Tachycardia or Dyspnea)
Number of participants with hypertension, hypotension, bradycardia, tachycardia or dyspnea during the surgery.
Measured: throughout the operation duration, an average of 2 to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start5 May 2019
- Primary completion25 Aug 2020
- Study completion26 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Proximal Humeral FractureStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaofeng WANG, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919422
- Sponsor's protocol ID
- 2019-030
- Status last verified
- Jan 2021
- First submitted
- 14 Apr 2019
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang X, Zhang H, Chen Y, Zhang Q, Xie Z, Liao J, Jiang W, Zhang J. Is It Useful and Necessary to Add a T2 Paravertebral Block to the Regional Anesthesia During Proximal Humeral Fracture Surgery in Elderly Patients? A Prospective and Randomized Controlled Trial. Front Surg. 2022 Mar 14;9:755298. doi: 10.3389/fsurg.2022.755298. eCollection 2022.
PubMed 35360431Wang X, Zhang H, Xie Z, Zhang Q, Jiang W, Zhang J. The effectiveness of additional thoracic paravertebral block in improving the anesthetic effects of regional anesthesia for proximal humeral fracture surgery in elderly patients: study protocol for a randomized controlled trial. Trials. 2020 Feb 19;21(1):204. doi: 10.1186/s13063-020-4078-9.
PubMed 32075674
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Additional Thoracic Paravertebral Block in Improving Anesthetic Effects of Regional Anesthesia for Proximal Humeral Fracture Surgery in Elderly Patients: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03919422
- Acronym / sponsor ID
- 2019-030
- Conditions
- Proximal Humeral Fracture
- Keywords
- thoracic paravertebral block, regional anesthesia, elderly, proximal humeral fracture, brachial plexus block, cervical plexus block, intercostobrachial nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 5 May 2019 (actual)
- Primary completion
- 25 Aug 2020 (actual)
- Study completion
- 26 Aug 2020 (actual)
- First posted
- 18 Apr 2019 (actual)
- Results
- Posted 5 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effects of T2 paravertebral block block improving interscalene brachial plexus block and superficial cervical plexus block on the relief of pain intensity during elderly proximal humerus fracture fixation surgery. The brachial plexus and cervical plexus block(IC block) will be performed in half of participants, while the T2 paravertebral block combined with IC block will be performed in the other half.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IC group | Active comparator | Procedure: interscalene brachial plexus block and superficial cervical plexus blockInterscalene brachial plexus-Cervical plexus |
| ICTP group | Experimental | Procedure: T2 paravertebral block, Procedure: interscalene brachial plexus block and superficial cervical plexus blockInterscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Participant age≥ 65 years
- Body mass index (BMI) < 30kg/m2
- American Society of Anesthesiologists (ASA) classification I-II
- Anterior operative incision approach
Key exclusion criteria (10 listed)
- Request for general anesthesia
- Nerve block is unable to be performed due to various reasons
- Coagulation dysfunction or anticoagulation therapy
- History of upper limb nerve injury or phrenic nerve injury
- Multiple trauma
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 |
|---|---|---|
| T2 paravertebral blockAlso: T2 PVB(paravertebral blockade )Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin). | Procedure or surgery | ICTP group |
| interscalene brachial plexus block and superficial cervical plexus blockAlso: IC blockAn ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus. | Procedure or surgery | IC group, ICTP group |
Primary outcome
Success Rate(Ability to Proceed With Surgery Without the Need for Intravenous Narcotics, General Anaesthesia, Rescue Blocks or Local Infiltration by the Surgeon)
Time frame: throughout the operation duration, an average of 2 to 3 hours
Success rate - was equivalent to surgical anesthesia, defined as the ability to proceed with surgery without the need for intravenous narcotics, general anaesthesia, rescue blocks or local infiltration by the surgeon.
7 secondary outcomes
Assessment of Sensory Blockade
Time frame: 20 minutes after all the nerve block operations have been finished
Proportion of Participants Completed the Procedure With Remifentanil
Time frame: throughout the operation duration, an average of 2 to 3 hours
Proportion of Participants Conversed Into General Anesthesia(Laryngeal Mask Airway,LMA)
Time frame: throughout the operation duration, an average of 2 to 3 hours
Cumulative Doses of Intraoperative Vasoactive Medications (Urapidil,Atropine, Ephedrine)
Time frame: At the end of surgical procedure(an average of 2 to 3 hours)
Cumulative Doses of Intraoperative Vasoactive Medications (Deoxyepinephrine)
Time frame: At the end of surgical procedure(an average of 2 to 3 hours)
Complications Related With Anesthesia
Time frame: within 24 hours since the nerve block finished
Intraoperative Adverse Reactions (Including Hypertension, Hypotension, Bradycardia, Tachycardia or Dyspnea)
Time frame: throughout the operation duration, an average of 2 to 3 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35360431Wang X, Zhang H, Chen Y, Zhang Q, Xie Z, Liao J, Jiang W, Zhang J. Is It Useful and Necessary to Add a T2 Paravertebral Block to the Regional Anesthesia During Proximal Humeral Fracture Surgery in Elderly Patients? A Prospective and Randomized Controlled Trial. Front Surg. 2022 Mar 14;9:755298. doi: 10.3389/fsurg.2022.755298. eCollection 2022.
- Derived from this study: PubMed 32075674Wang X, Zhang H, Xie Z, Zhang Q, Jiang W, Zhang J. The effectiveness of additional thoracic paravertebral block in improving the anesthetic effects of regional anesthesia for proximal humeral fracture surgery in elderly patients: study protocol for a randomized controlled trial. Trials. 2020 Feb 19;21(1):204. doi: 10.1186/s13063-020-4078-9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T2 paravertebral block and interscalene brachial plexus block and superficial cervical plexus block in people with Proximal Humeral Fracture, run by Shanghai 6th 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 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: finished, as of the sponsor's last update on 5 Jan 2021. 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?
Yes. Results are posted in the registry (first posted 5 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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(Ability to Proceed With Surgery Without the Need for Intravenous Narcotics, General Anaesthesia, Rescue Blocks or Local Infiltration by the Surgeon) (time frame: throughout the operation duration, an average of 2 to 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03919422, which also lists 2 linked publications.
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 5 Jan 2021.