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Paravertebral Block for Proximal Humeral Fracture Surgery

Primary Purpose

Proximal Humeral Fracture

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
T2 paravertebral block
interscalene brachial plexus block and superficial cervical plexus block
Sponsored by
Shanghai 6th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proximal Humeral Fracture focused on measuring thoracic paravertebral block, regional anesthesia, elderly, proximal humeral fracture, brachial plexus block, cervical plexus block, intercostobrachial nerve

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

IC group

ICTP group

Arm Description

Interscalene brachial plexus-Cervical plexus

Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.
Cumulative Doses of Intraoperative Vasoactive Medications (Urapidil,Atropine, Ephedrine)
Cumulative doses of vasoactive drugs required such as urapidil,atropine, ephedrine during the surgery.
Cumulative Doses of Intraoperative Vasoactive Medications (Deoxyepinephrine)
Cumulative doses of intravenous deoxyepinephrine required during the surgery.
Complications Related With Anesthesia
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)
Number of participants with hypertension, hypotension, bradycardia, tachycardia or dyspnea during the surgery.

Full Information

First Posted
April 14, 2019
Last Updated
January 2, 2021
Sponsor
Shanghai 6th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03919422
Brief Title
Paravertebral Block for Proximal Humeral Fracture Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 5, 2019 (Actual)
Primary Completion Date
August 25, 2020 (Actual)
Study Completion Date
August 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 6th People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proximal Humeral Fracture
Keywords
thoracic paravertebral block, regional anesthesia, elderly, proximal humeral fracture, brachial plexus block, cervical plexus block, intercostobrachial nerve

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IC group
Arm Type
Active Comparator
Arm Description
Interscalene brachial plexus-Cervical plexus
Arm Title
ICTP group
Arm Type
Experimental
Arm Description
Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade
Intervention Type
Procedure
Intervention Name(s)
T2 paravertebral block
Other Intervention Name(s)
T2 PVB(paravertebral blockade )
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
interscalene brachial plexus block and superficial cervical plexus block
Other Intervention Name(s)
IC block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Success Rate(Ability to Proceed With Surgery Without the Need for Intravenous Narcotics, General Anaesthesia, Rescue Blocks or Local Infiltration by the Surgeon)
Description
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.
Time Frame
throughout the operation duration, an average of 2 to 3 hours
Secondary Outcome Measure Information:
Title
Assessment of Sensory Blockade
Description
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
Time Frame
20 minutes after all the nerve block operations have been finished
Title
Proportion of Participants Completed the Procedure With Remifentanil
Description
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.
Time Frame
throughout the operation duration, an average of 2 to 3 hours
Title
Proportion of Participants Conversed Into General Anesthesia(Laryngeal Mask Airway,LMA)
Description
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.
Time Frame
throughout the operation duration, an average of 2 to 3 hours
Title
Cumulative Doses of Intraoperative Vasoactive Medications (Urapidil,Atropine, Ephedrine)
Description
Cumulative doses of vasoactive drugs required such as urapidil,atropine, ephedrine during the surgery.
Time Frame
At the end of surgical procedure(an average of 2 to 3 hours)
Title
Cumulative Doses of Intraoperative Vasoactive Medications (Deoxyepinephrine)
Description
Cumulative doses of intravenous deoxyepinephrine required during the surgery.
Time Frame
At the end of surgical procedure(an average of 2 to 3 hours)
Title
Complications Related With Anesthesia
Description
Presence or absence of local anesthetic systemic toxicity, pneumothorax, and epidural block, total spinal block, hematoma
Time Frame
within 24 hours since the nerve block finished
Title
Intraoperative Adverse Reactions (Including Hypertension, Hypotension, Bradycardia, Tachycardia or Dyspnea)
Description
Number of participants with hypertension, hypotension, bradycardia, tachycardia or dyspnea during the surgery.
Time Frame
throughout the operation duration, an average of 2 to 3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant age≥ 65 years Body mass index (BMI) < 30kg/m2 American Society of Anesthesiologists (ASA) classification I-II Anterior operative incision approach Exclusion Criteria: 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.) 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)
Facility Information:
Facility Name
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200233
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
35360431
Citation
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.
Results Reference
derived
PubMed Identifier
32075674
Citation
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.
Results Reference
derived

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Paravertebral Block for Proximal Humeral Fracture Surgery

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