Clinical trial NCT03785392: Out of Plane Approach for Interscalene
Official title: Out of Plane Approach for Interscalene Level Brachial Plexus Block to Avoid Phrenic Nerve Involvement - a Prospective Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Pain
Brachial Plexus Block
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study aims to examine the influence of out of plane interscalene approach to a brachial plexus block on the effect of phrenic nerve blockade.

Detailed description: Studies have proven that there is 100% blockade of the phrenic nerve with the in-plane approach to the interscalene brachial plexus block. The patient population with pulmonary comorbidities with poor reserve cannot afford to have a further deterioration of their pulmonary status due to phrenic nerve blockade. These patients are not ideal candidates for increased opiate therapy for intraoperative and post-surgical pain as well due to further depression of their respiratory function. To optimize their pain control as well as avoid any respiratory-related morbidity and mortality, it is ideal to develop a technique which can provide appropriate brachial plexus block at the interscalene level while completely avoiding any local anesthetic spread to the phrenic nerve.

The study aims to examine the influence of out of plane interscalene approach to a brachial plexus block on the effect of phrenic nerve blockade. Practitioner preference and institutional norms often influence the in plane approach for the above-mentioned block. The most common practice at our institution is the in plane approach to the brachial plexus block.

Eligibility criteria: Inclusion Criteria:

* Adult patients(18-85 years old)
* Scheduled for elective shoulder surgery who would benefit from a preoperative interscalene approach to the brachial plexus block for intraoperative and postoperative pain relief.

Exclusion Criteria:

* Patients with any distorted anatomy for whom the block cannot be performed accurately, such as scars, surgical fixtures at the site, active infection, any open wound or drains at the site.
* Patients who request benzodiazepine anxiolytics such as midazolam for premedication before the procedure. Also patients who request narcotic medications as premedication before the procedure
* Non-English and Non-Spanish speaking patients
* Inadequate or failed blocks and inadvertently intrathecal or intravascular injection will be dropped from the study
* Incarcerated patients
* Expected heavy bleeding on multiple anticoagulants with markedly elevated PT ( Prothrombin time ), INR (International Normalized Ratio ), PTT ( Partial Thromboplastin Time ) levels and markedly reduced platelet counts

Primary outcomes:
measure: Forced Expiratory Volume (FEV1)
timeFrame: The change in Forced Expiratory Volume in one second (FEV1) from Baseline to 15 minutes
Secondary outcomes:
measure: Forced Vital Capacity (FVC)
timeFrame: The change in Forced Vital Capacity (FVC) from Baseline to 15 minutes
Other outcomes:
Locations:
city: Galveston
country: United States
facility: UTMB
state: Texas
city: League City
country: United States
facility: UTMB
state: Texas
Study officials:
affiliation: UTMB
name: Ranganathan Govindaraj, MD
role: PRINCIPAL_INVESTIGATOR
References: