Paravertebral Block for Proximal Humeral Fracture Surgery

Not Applicable

Completed

• Conditions: Proximal Humeral Fracture
• Interventions: Procedure: T2 paravertebral block; Procedure: interscalene brachial plexus block and superficial cervical plexus block

• Registration Number: NCT03919422
• Lead Sponsor: Shanghai 6th People's Hospital

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 available

Study Timeline

• Study First Submitted: 2019-04-14
• Study First Submitted QC: 2019-04-16
• Study First Posted: 2019-04-18
• Study Start: 2019-05-05
• Primary Completion: 2020-08-25
• Study Completion: 2020-08-26
• Results First Submitted: 2020-11-06
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-02
• Last Update Submitted: 2021-01-02
• Results First Posted: 2021-01-05
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICTP group	T2 paravertebral block	Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade
IC group	interscalene brachial plexus block and superficial cervical plexus block	Interscalene brachial plexus-Cervical plexus
ICTP group	interscalene brachial plexus block and superficial cervical plexus block	Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.
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.
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.

Trial Locations

Locations (1)

Shanghai Jiao Tong University Affiliated Sixth People's Hospital; 🇨🇳 Shanghai, Shanghai, China