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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IC group | Active Comparator | Interscalene brachial plexus-Cervical plexus |
|
| ICTP group | Experimental | Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T2 paravertebral block | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | throughout the operation duration, an average of 2 to 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 20 minutes after all the nerve block operations have been finished |
| Proportion of Participants Completed the Procedure With Remifentanil |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Jiao Tong University Affiliated Sixth People's Hospital | Shanghai | Shanghai Municipality | 200233 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35360431 | Derived | 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. | |
| 32075674 |
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121participants were screened. 41 did not meet criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | IC Group | Interscalene brachial plexus-Cervical plexus interscalene brachial plexus block and superficial cervical plexus 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. |
| FG001 | ICTP Group | Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade T2 paravertebral block: 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 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IC Group | Interscalene brachial plexus-Cervical plexus interscalene brachial plexus block and superficial cervical plexus 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | throughout the operation duration, an average of 2 to 3 hours |
|
1day after surgery
Block-related complications such as local anesthetic systemic toxicity, pneumothorax, epidural block, total spinal block and hematoma were defined as Severe Adverse Events. The intraoperative adverse reactions including hypertension, hypotension, bradycardia, tachycardia and dyspnea were defined as Other Adverse Events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IC Group | Interscalene brachial plexus-Cervical plexus interscalene brachial plexus block and superficial cervical plexus 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| local anesthetic systemic toxicity | Nervous system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Junfen Zhang, director of the clinical trial | Department of Anesthesiology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital | +8618930173689 | zhangjunfeng@sjtu.edu.cn |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2019 | Jan 2, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012784 | Shoulder Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
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|
|
| interscalene brachial plexus block and superficial cervical plexus block | Procedure | 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. |
|
|
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. |
| 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. | 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. | 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. | 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 | 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. | throughout the operation duration, an average of 2 to 3 hours |
| Wang 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. |
| BG001 | ICTP Group | Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade T2 paravertebral block: 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 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| ASA | The ASA risk classification system can be used to quantify the risk associated with anesthesia and surgery. ASA I: Healthy patient without organic, biochemical, or psychiatric disease. ASA II: A patient with mild systemic disease. ASA III: Significant or severe systemic disease that limits normal activity. ASA IV: Severe disease that is a constant threat to life or requires intensive therapy. ASA V: Moribund patient who is equally likely to die in the next 24 hours with or without surgery. ASA VI: Brain-dead organ donor. | Count of Participants | Participants | No |
|
| duration of surgery | Median | Inter-Quartile Range | minutes |
|
| height | Mean | Standard Deviation | cm |
|
| OG001 | ICTP Group | Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade T2 paravertebral block: 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 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. |
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 20 minutes after all the nerve block operations have been finished |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | throughout the operation duration, an average of 2 to 3 hours |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | throughout the operation duration, an average of 2 to 3 hours |
|
|
|
| Secondary | Cumulative Doses of Intraoperative Vasoactive Medications (Urapidil,Atropine, Ephedrine) | Cumulative doses of vasoactive drugs required such as urapidil,atropine, ephedrine during the surgery. | Posted | Mean | Standard Deviation | mg | At the end of surgical procedure(an average of 2 to 3 hours) |
|
|
|
| Secondary | Cumulative Doses of Intraoperative Vasoactive Medications (Deoxyepinephrine) | Cumulative doses of intravenous deoxyepinephrine required during the surgery. | Posted | Mean | Standard Deviation | ug | At the end of surgical procedure(an average of 2 to 3 hours) |
|
|
|
| Secondary | Complications Related With Anesthesia | Presence or absence of local anesthetic systemic toxicity, pneumothorax, and epidural block, total spinal block, hematoma | Posted | Count of Participants | Participants | within 24 hours since the nerve block finished |
|
|
|
| Secondary | Intraoperative Adverse Reactions (Including Hypertension, Hypotension, Bradycardia, Tachycardia or Dyspnea) | Number of participants with hypertension, hypotension, bradycardia, tachycardia or dyspnea during the surgery. | Posted | Count of Participants | Participants | throughout the operation duration, an average of 2 to 3 hours |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 20 |
| 40 |
| EG001 | ICTP Group | Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade T2 paravertebral block: 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 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. | 0 | 40 | 0 | 40 | 23 | 40 |
| pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| epidural block | Nervous system disorders | Non-systematic Assessment |
|
| total spinal block | Nervous system disorders | Non-systematic Assessment |
|
| hematoma | Vascular disorders | Non-systematic Assessment |
|
| hypotension | Cardiac disorders | Systematic Assessment |
|
| bradycardia | Cardiac disorders | Systematic Assessment |
|
| tachycardia | Cardiac disorders | Systematic Assessment |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| complete block |
|
| deltoid area |
|
| lateral part of upper arm |
|
| medial part of upper arm |
|
| ephedrine (mg) |
|
| epidural block |
|
| total spinal block |
|
| hematoma |
|
| Number of participants with bradycardia during the surgery |
|
| Number of participants with tachycardia druing the surgery |
|
| Number of participants with dyspnea during the surgery |
|