N/A
N=80
Paravertebral Block for Proximal Humeral Fracture Surgery
Proximal Humeral Fracture
Bottom Line
View on ClinicalTrials.gov: NCT03919422 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Success Rate(Ability to Proceed With Surgery Without the Need for Intravenous Narcotics, General Anaesthesia, Rescue Blocks or Local Infiltration by the Surgeon) — 31; 21 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- T2 paravertebral block (Procedure); interscalene brachial plexus block and superficial cervical plexus block (Procedure)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Shanghai 6th People's Hospital
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success Rate(Ability to Proceed With Surgery Without the Need for Intravenous Narcotics, General Anaesthesia, Rescue Blocks or Local Infiltration by the Surgeon) |
31; 21 | — |
| SECONDARY Assessment of Sensory Blockade |
1; 0; 2; 1; 37; 39 | — |
| SECONDARY Proportion of Participants Completed the Procedure With Remifentanil |
13; 7 | — |
| SECONDARY Proportion of Participants Conversed Into General Anesthesia(Laryngeal Mask Airway,LMA) |
6; 2 | — |
| SECONDARY Cumulative Doses of Intraoperative Vasoactive Medications (Urapidil,Atropine, Ephedrine) |
1.13; 1.50; 0.05; 0.09; 1.00; 0.5 | — |
| SECONDARY Cumulative Doses of Intraoperative Vasoactive Medications (Deoxyepinephrine) |
5.0; 7.5 | — |
| SECONDARY Complications Related With Anesthesia |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Intraoperative Adverse Reactions (Including Hypertension, Hypotension, Bradycardia, Tachycardia or Dyspnea) |
6; 7; 4; 5; 5; 8 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT03919422). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.