Imaging of local anesthetic fluid distribution using magnetic resonance (MRI), comparing a low and a high volume of local anesthetic for shoulder and upper arm surgery

• Conditions: Surgery of the shoulder and/or upper extremity using interscalene brachial plexus block; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2013-004219-36-AT
• Lead Sponsor: Paracelsus Mediznische Privatuniversität, Universitätsklinik für Anästhesiologie, perioperative Medizin und Intensiv

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-22
• Last Update Posted: 14 July 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Age between 18 and 75 years
- Surgery of the shoulder (shoulder arthroscopy, open shoulder joint surgery, rotator cuff surgery, tendon transfer, shoulder arthroplasty, humerus fracture surgery)
- Informed consent to participate in the study
- American Society of Anesthesiologists physical score I, II or III
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Refusal to participate in the study
- Inability to understand the study protocol due to language barrier
- Serious cardiac or pulmonary disease such as decompensated heart failure, recent myocardial infarction (less than one month in the past), heart block greater than 2nd degree, obstructive sleep apnea and chronic obstructive lung disease greater than 2nd degree
- renal impairment with an aGFR < 60ml/min
- Hypersensitivity to ropivacaine or gadolinium or other contraindications against peripheral nerve blocks
- Chronic opioid usage greater than 15 mg oral morphine equivalents daily, the daily use of adjunctive pain medications (gabapentinoids, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors)
- Schizophrenia or bipolar disorders, uncontrolled anxiety, claustrophobia
- Peripheral neuropathy
- Hepatic or renal impairment
- Ongoing illicit drug or alcohol abuse
- Metal implants or other contraindications for magnetic resonance imaging
- Coagulopathy
- Participation in additional clinical trials within 4 weeks before screening
- Hearing impairment
- Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to confirm that the frequency of epidural spread correlates with higher volumes of local anesthetic injection (5ml vs 20ml) after interscalene brachial plexus block.;Secondary Objective: Secondary objectives include evaluation of block effectiveness, duration, incidence of side effects, and patient satisfaction.;Primary end point(s): Spread of local anesthetics to the epidural space;Timepoint(s) of evaluation of this end point: immediately after block placement

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Contralateral epidural spread.<br>- Spread of local anesthetics to the phrenic nerve.<br>- Bed side spirometry and ultrasound investigation of the diaphragm in the PACU.<br>- Oxygen saturation in the PACU<br>- Self-reported block duration.<br>- Self reported pain scores for the first 24 postoperative hours <br>- Time to first analgesic consumption on demand. <br>- Total analgesic consumption (ropivacaine PCA).;Timepoint(s) of evaluation of this end point: immediately after block placement<br>before block placement, post surgery, at 4h, 8h, 10h, 12h, 14h, on postop day 1