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出境医 / 临床实验 / Paravertebral Block for Proximal Humeral Fracture Surgery

Paravertebral Block for Proximal Humeral Fracture Surgery

Study Description
Brief 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. 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.

Condition or disease Intervention/treatment Phase
Proximal Humeral Fracture Procedure: T2 paravertebral block Procedure: interscalene brachial plexus block and superficial cervical plexus block Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 5, 2019
Actual Primary Completion Date : August 25, 2020
Actual Study Completion Date : August 26, 2020
Arms and Interventions
Arm Intervention/treatment
Active Comparator: IC group
Interscalene brachial plexus-Cervical plexus
 Procedure: 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.
Other Name: IC block
Experimental: ICTP group
Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade
 Procedure: 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).
Other Name: T2 PVB(paravertebral blockade )

Procedure: 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.
Other Name: IC block
Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Assessment of Sensory Blockade [ Time Frame: 20 minutes after all the nerve block operations have been finished ]
    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

  2. Proportion of Participants Completed the Procedure With Remifentanil [ Time Frame: throughout the operation duration, an average of 2 to 3 hours ]
    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.

  3. Proportion of Participants Conversed Into General Anesthesia(Laryngeal Mask Airway,LMA) [ Time Frame: throughout the operation duration, an average of 2 to 3 hours ]
    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.

  4. 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 vasoactive drugs required such as urapidil,atropine, ephedrine during the surgery.

  5. Cumulative Doses of Intraoperative Vasoactive Medications (Deoxyepinephrine) [ Time Frame: At the end of surgical procedure(an average of 2 to 3 hours) ]
    Cumulative doses of intravenous deoxyepinephrine required during the surgery.

  6. Complications Related With Anesthesia [ Time Frame: within 24 hours since the nerve block finished ]
    Presence or absence of local anesthetic systemic toxicity, pneumothorax, and epidural block, total spinal block, hematoma

  7. Intraoperative Adverse Reactions (Including Hypertension, Hypotension, Bradycardia, Tachycardia or Dyspnea) [ Time Frame: throughout the operation duration, an average of 2 to 3 hours ]
    Number of participants with hypertension, hypotension, bradycardia, tachycardia or dyspnea during the surgery.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participant age≥ 65 years
  2. Body mass index (BMI) < 30kg/m2
  3. American Society of Anesthesiologists (ASA) classification I-II
  4. Anterior operative incision approach

Exclusion Criteria:

  1. Request for general anesthesia
  2. Nerve block is unable to be performed due to various reasons
  3. Coagulation dysfunction or anticoagulation therapy
  4. History of upper limb nerve injury or phrenic nerve injury
  5. Multiple trauma
  6. Uncontrolled respiratory disease (severe chronic obstructive pulmonary disease, asthma, pulmonary infection, pneumothorax, etc.)
  7. Uncontrolled hypertension (systolic pressure over 180mmHg or diastolic pressure over 110mmHg)
  8. Uncontrolled heart disease (coronary heart disease, valvular disease or arrhythmia, etc.)
  9. Stroke or cognitive dysfunction (unable to communicate or cooperate)
  10. Hypersensitivity or allergy to anesthetics (ropivacaine or remifentanil)
Contacts and Locations

Locations
Layout table for location information
China, Shanghai
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai, Shanghai, China, 200233
Sponsors and Collaborators
Shanghai 6th People's Hospital
Tracking Information
First Submitted Date  ICMJE April 14, 2019
First Posted Date  ICMJE April 18, 2019
Results First Submitted Date  ICMJE November 6, 2020
Results First Posted Date  ICMJE January 5, 2021
Last Update Posted Date January 5, 2021
Actual Study Start Date  ICMJE May 5, 2019
Actual Primary Completion Date August 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2021)
  • Assessment of Sensory Blockade [ Time Frame: 20 minutes after all the nerve block operations have been finished ]
    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
  • Proportion of Participants Completed the Procedure With Remifentanil [ Time Frame: throughout the operation duration, an average of 2 to 3 hours ]
    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.
  • Proportion of Participants Conversed Into General Anesthesia(Laryngeal Mask Airway,LMA) [ Time Frame: throughout the operation duration, an average of 2 to 3 hours ]
    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.
  • 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 vasoactive drugs required such as urapidil,atropine, ephedrine during the surgery.
  • Cumulative Doses of Intraoperative Vasoactive Medications (Deoxyepinephrine) [ Time Frame: At the end of surgical procedure(an average of 2 to 3 hours) ]
    Cumulative doses of intravenous deoxyepinephrine required during the surgery.
  • Complications Related With Anesthesia [ Time Frame: within 24 hours since the nerve block finished ]
    Presence or absence of local anesthetic systemic toxicity, pneumothorax, and epidural block, total spinal block, hematoma
  • Intraoperative Adverse Reactions (Including Hypertension, Hypotension, Bradycardia, Tachycardia or Dyspnea) [ Time Frame: throughout the operation duration, an average of 2 to 3 hours ]
    Number of participants with hypertension, hypotension, bradycardia, tachycardia or dyspnea during the surgery.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
  • Sensory blockade [ Time Frame: 20 minutes after all the nerve block operations have been finished ]
    Sensory blockade graded from 0 to 2(0= no block, 1= partial block and 2= complete block) by applying pinprick to the shoulder
  • Proportion of participants who can complete the procedure with Remifentanil [ Time Frame: throughout the operation duration, an average of 2 to 3 hours ]
    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.
  • Conversion into general anesthesia(Laryngeal Mask Airway,LMA) [ Time Frame: throughout the operation duration, an average of 2 to 3 hours ]
    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.
  • Cumulative doses of intraoperative vasoactive medications [ Time Frame: At the end of surgical procedure(an average of 2 to 3 hours) ]
    Cumulative doses of vasoactive drugs required such as urapidil,atropine, ephedrine and deoxyepinephrine.
  • Complications related with nerve block [ Time Frame: 24 hours ]
    Presence or absence of vascular puncture, local anesthetic systemic toxicity, pneumothorax, and paresthesia
  • Intraoperative adverse reactions [ Time Frame: throughout the operation duration, an average of 2 to 3 hours ]
    Hypertension, hypotension, bradycardia, tachycardia, respiratory depression, pneumothorax
  • Numerical pain rating score [ Time Frame: 12 hours after surgery ]
    Numerical pain rating score ranging from 0 to 10 (0 = no pain, 10 = worst pain imaginable) 12 hours after surgery
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Paravertebral Block for Proximal Humeral Fracture Surgery
Official Title  ICMJE 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
Brief 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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Proximal Humeral Fracture
Intervention  ICMJE
  • Procedure: 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).
    Other Name: T2 PVB(paravertebral blockade )
  • Procedure: 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.
    Other Name: IC block
Study Arms  ICMJE
  • Active Comparator: IC group
    Interscalene brachial plexus-Cervical plexus
    Intervention: Procedure: interscalene brachial plexus block and superficial cervical plexus block
  • Experimental: ICTP group
    Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade
    Interventions:
    • Procedure: T2 paravertebral block
    • Procedure: interscalene brachial plexus block and superficial cervical plexus block
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2019) 		80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 26, 2020
Actual Primary Completion Date August 25, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Participant age≥ 65 years
  2. Body mass index (BMI) < 30kg/m2
  3. American Society of Anesthesiologists (ASA) classification I-II
  4. Anterior operative incision approach

Exclusion Criteria:

  1. Request for general anesthesia
  2. Nerve block is unable to be performed due to various reasons
  3. Coagulation dysfunction or anticoagulation therapy
  4. History of upper limb nerve injury or phrenic nerve injury
  5. Multiple trauma
  6. Uncontrolled respiratory disease (severe chronic obstructive pulmonary disease, asthma, pulmonary infection, pneumothorax, etc.)
  7. Uncontrolled hypertension (systolic pressure over 180mmHg or diastolic pressure over 110mmHg)
  8. Uncontrolled heart disease (coronary heart disease, valvular disease or arrhythmia, etc.)
  9. Stroke or cognitive dysfunction (unable to communicate or cooperate)
  10. Hypersensitivity or allergy to anesthetics (ropivacaine or remifentanil)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03919422
Other Study ID Numbers  ICMJE 2019-030
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xiaofeng WANG, Shanghai 6th People's Hospital
Study Sponsor  ICMJE Shanghai 6th People's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shanghai 6th People's Hospital
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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