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Completed

NCT Number: NCT03919422

Paravertebral Block for Proximal Humeral Fracture Surgery

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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Key information

Conditions

Proximal Humeral Fracture Fractures, Bone Shoulder Fractures Shoulder Injuries Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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).

Other names: T2 PVB(paravertebral blockade )

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.

Other names: IC block

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Shanghai 6th People's Hospital

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 18, 2019
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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