Proximal Humeral Fracture
Conditions
Keywords
thoracic paravertebral block, regional anesthesia, elderly, proximal humeral fracture, brachial plexus block, cervical plexus block, intercostobrachial nerve
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.
Interventions
PROCEDURET2 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).
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.
Sponsors
Shanghai 6th People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate(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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Completed the Procedure With Remifentanil | 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) | 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) | 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. |
| Assessment of Sensory Blockade | 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 |
| Complications Related With Anesthesia | 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) | throughout the operation duration, an average of 2 to 3 hours | Number of participants with hypertension, hypotension, bradycardia, tachycardia or dyspnea during the surgery. |
| Cumulative Doses of Intraoperative Vasoactive Medications (Deoxyepinephrine) | At the end of surgical procedure(an average of 2 to 3 hours) | Cumulative doses of intravenous deoxyepinephrine required during the surgery. |
Countries
China
Participant flow
Recruitment details
121participants were screened. 41 did not meet criteria.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| 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. | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | IC Group | ICTP Group | Total |
|---|---|---|---|
| Age, Continuous | 74.8 years STANDARD_DEVIATION 6 | 74.5 years STANDARD_DEVIATION 6.5 | 74.7 years STANDARD_DEVIATION 6.2 |
| ASA ASA I | 14 Participants | 17 Participants | 31 Participants |
| ASA ASA II | 26 Participants | 23 Participants | 49 Participants |
| BMI | 24.3 kg/m^2 STANDARD_DEVIATION 3.2 | 24.4 kg/m^2 STANDARD_DEVIATION 3.8 | 24.4 kg/m^2 STANDARD_DEVIATION 3.5 |
| duration of surgery | 72.5 minutes | 70 minutes | 70 minutes |
| height | 157.2 cm STANDARD_DEVIATION 6.8 | 159.7 cm STANDARD_DEVIATION 7.2 | 159.7 cm STANDARD_DEVIATION 7.2 |
| Race/Ethnicity, Customized yellow race, Han nationality, China | 40 Participants | 40 Participants | 80 Participants |
| Sex: Female, Male Female | 34 Participants | 28 Participants | 62 Participants |
| Sex: Female, Male Male | 6 Participants | 12 Participants | 18 Participants |
| weight | 60.2 kg STANDARD_DEVIATION 9.1 | 62.5 kg STANDARD_DEVIATION 11.3 | 61.3 kg STANDARD_DEVIATION 10.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 20 / 40 | 23 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
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.
Time frame: throughout the operation duration, an average of 2 to 3 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IC Group | Success Rate(Ability to Proceed With Surgery Without the Need for Intravenous Narcotics, General Anaesthesia, Rescue Blocks or Local Infiltration by the Surgeon) | 31 Participants |
| ICTP Group | Success Rate(Ability to Proceed With Surgery Without the Need for Intravenous Narcotics, General Anaesthesia, Rescue Blocks or Local Infiltration by the Surgeon) | 21 Participants |
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
Time frame: 20 minutes after all the nerve block operations have been finished
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| IC Group | Assessment of Sensory Blockade | distal clavicle area | no block | 1 Participants |
| IC Group | Assessment of Sensory Blockade | distal clavicle area | partial block | 2 Participants |
| IC Group | Assessment of Sensory Blockade | distal clavicle area | complete block | 37 Participants |
| IC Group | Assessment of Sensory Blockade | deltoid area | no block | 0 Participants |
| IC Group | Assessment of Sensory Blockade | deltoid area | partial block | 3 Participants |
| IC Group | Assessment of Sensory Blockade | deltoid area | complete block | 37 Participants |
| IC Group | Assessment of Sensory Blockade | lateral part of upper arm | no block | 0 Participants |
| IC Group | Assessment of Sensory Blockade | lateral part of upper arm | partial block | 4 Participants |
| IC Group | Assessment of Sensory Blockade | lateral part of upper arm | complete block | 36 Participants |
| IC Group | Assessment of Sensory Blockade | medial part of upper arm | no block | 36 Participants |
| IC Group | Assessment of Sensory Blockade | medial part of upper arm | partial block | 4 Participants |
| IC Group | Assessment of Sensory Blockade | medial part of upper arm | complete block | 0 Participants |
| ICTP Group | Assessment of Sensory Blockade | medial part of upper arm | partial block | 17 Participants |
| ICTP Group | Assessment of Sensory Blockade | distal clavicle area | no block | 0 Participants |
| ICTP Group | Assessment of Sensory Blockade | lateral part of upper arm | no block | 0 Participants |
| ICTP Group | Assessment of Sensory Blockade | distal clavicle area | partial block | 1 Participants |
| ICTP Group | Assessment of Sensory Blockade | medial part of upper arm | no block | 6 Participants |
| ICTP Group | Assessment of Sensory Blockade | distal clavicle area | complete block | 39 Participants |
| ICTP Group | Assessment of Sensory Blockade | lateral part of upper arm | partial block | 3 Participants |
| ICTP Group | Assessment of Sensory Blockade | deltoid area | no block | 0 Participants |
| ICTP Group | Assessment of Sensory Blockade | medial part of upper arm | complete block | 17 Participants |
| ICTP Group | Assessment of Sensory Blockade | deltoid area | partial block | 2 Participants |
| ICTP Group | Assessment of Sensory Blockade | lateral part of upper arm | complete block | 37 Participants |
| ICTP Group | Assessment of Sensory Blockade | deltoid area | complete block | 38 Participants |
Secondary
Complications Related With Anesthesia
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IC Group | Complications Related With Anesthesia | hematoma | 0 Participants |
| IC Group | Complications Related With Anesthesia | local anesthetic systemic toxicity | 0 Participants |
| IC Group | Complications Related With Anesthesia | pneumothorax | 0 Participants |
| IC Group | Complications Related With Anesthesia | epidural block | 0 Participants |
| IC Group | Complications Related With Anesthesia | total spinal block | 0 Participants |
| ICTP Group | Complications Related With Anesthesia | total spinal block | 0 Participants |
| ICTP Group | Complications Related With Anesthesia | epidural block | 0 Participants |
| ICTP Group | Complications Related With Anesthesia | local anesthetic systemic toxicity | 0 Participants |
| ICTP Group | Complications Related With Anesthesia | hematoma | 0 Participants |
| ICTP Group | Complications Related With Anesthesia | pneumothorax | 0 Participants |
Secondary
Cumulative Doses of Intraoperative Vasoactive Medications (Deoxyepinephrine)
Cumulative doses of intravenous deoxyepinephrine required during the surgery.
Time frame: At the end of surgical procedure(an average of 2 to 3 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IC Group | Cumulative Doses of Intraoperative Vasoactive Medications (Deoxyepinephrine) | 5.0 ug | Standard Deviation 18.9 |
| ICTP Group | Cumulative Doses of Intraoperative Vasoactive Medications (Deoxyepinephrine) | 7.5 ug | Standard Deviation 29 |
Secondary
Cumulative Doses of Intraoperative Vasoactive Medications (Urapidil,Atropine, Ephedrine)
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IC Group | Cumulative Doses of Intraoperative Vasoactive Medications (Urapidil,Atropine, Ephedrine) | urapidil (mg) | 1.13 mg | Standard Deviation 2.9 |
| IC Group | Cumulative Doses of Intraoperative Vasoactive Medications (Urapidil,Atropine, Ephedrine) | atropine (mg) | 0.05 mg | Standard Deviation 0.2 |
| IC Group | Cumulative Doses of Intraoperative Vasoactive Medications (Urapidil,Atropine, Ephedrine) | ephedrine (mg) | 1.00 mg | Standard Deviation 3.3 |
| ICTP Group | Cumulative Doses of Intraoperative Vasoactive Medications (Urapidil,Atropine, Ephedrine) | urapidil (mg) | 1.50 mg | Standard Deviation 3.6 |
| ICTP Group | Cumulative Doses of Intraoperative Vasoactive Medications (Urapidil,Atropine, Ephedrine) | atropine (mg) | 0.09 mg | Standard Deviation 0.2 |
| ICTP Group | Cumulative Doses of Intraoperative Vasoactive Medications (Urapidil,Atropine, Ephedrine) | ephedrine (mg) | 0.5 mg | Standard Deviation 2.2 |
Secondary
Intraoperative Adverse Reactions (Including Hypertension, Hypotension, Bradycardia, Tachycardia or Dyspnea)
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IC Group | Intraoperative Adverse Reactions (Including Hypertension, Hypotension, Bradycardia, Tachycardia or Dyspnea) | Number of participants with hypotension during the surgery | 4 Participants |
| IC Group | Intraoperative Adverse Reactions (Including Hypertension, Hypotension, Bradycardia, Tachycardia or Dyspnea) | Number of participants with tachycardia druing the surgery | 0 Participants |
| IC Group | Intraoperative Adverse Reactions (Including Hypertension, Hypotension, Bradycardia, Tachycardia or Dyspnea) | Number of participants with bradycardia during the surgery | 5 Participants |
| IC Group | Intraoperative Adverse Reactions (Including Hypertension, Hypotension, Bradycardia, Tachycardia or Dyspnea) | Number of participants with dyspnea during the surgery | 5 Participants |
| IC Group | Intraoperative Adverse Reactions (Including Hypertension, Hypotension, Bradycardia, Tachycardia or Dyspnea) | Number of participants with hypertension during the surgery | 6 Participants |
| ICTP Group | Intraoperative Adverse Reactions (Including Hypertension, Hypotension, Bradycardia, Tachycardia or Dyspnea) | Number of participants with dyspnea during the surgery | 2 Participants |
| ICTP Group | Intraoperative Adverse Reactions (Including Hypertension, Hypotension, Bradycardia, Tachycardia or Dyspnea) | Number of participants with hypertension during the surgery | 7 Participants |
| ICTP Group | Intraoperative Adverse Reactions (Including Hypertension, Hypotension, Bradycardia, Tachycardia or Dyspnea) | Number of participants with hypotension during the surgery | 5 Participants |
| ICTP Group | Intraoperative Adverse Reactions (Including Hypertension, Hypotension, Bradycardia, Tachycardia or Dyspnea) | Number of participants with bradycardia during the surgery | 8 Participants |
| ICTP Group | Intraoperative Adverse Reactions (Including Hypertension, Hypotension, Bradycardia, Tachycardia or Dyspnea) | Number of participants with tachycardia druing the surgery | 1 Participants |
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.
Time frame: throughout the operation duration, an average of 2 to 3 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IC Group | Proportion of Participants Completed the Procedure With Remifentanil | 13 Participants |
| ICTP Group | Proportion of Participants Completed the Procedure With Remifentanil | 7 Participants |
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.
Time frame: throughout the operation duration, an average of 2 to 3 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IC Group | Proportion of Participants Conversed Into General Anesthesia(Laryngeal Mask Airway,LMA) | 6 Participants |
| ICTP Group | Proportion of Participants Conversed Into General Anesthesia(Laryngeal Mask Airway,LMA) | 2 Participants |