Out of Plane Approach for Interscalene

Not Applicable

Terminated

• Conditions: Brachial Plexus Block; Acute Pain
• Interventions: Procedure: Group 2 out of plane; Procedure: Group 1 In-plane

• Registration Number: NCT03785392
• Lead Sponsor: The University of Texas Medical Branch, Galveston

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.

Study Timeline

• Study First Submitted: 2018-11-07
• Study First Submitted QC: 2018-12-21
• Study First Posted: 2018-12-24
• Study Start: 2019-03-29
• Primary Completion: 2019-12-08
• Study Completion: 2019-12-08
• Status Verified: 2020-10
• Last Update Submitted: 2020-12-01
• Last Update Posted: 2020-12-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 out of plane	Group 2 out of plane	Study with the technique out of plane
Group 1 Inplane	Group 1 In-plane	Study with the technique Inplane group

Primary Outcome Measures

Name	Time	Method
Forced Expiratory Volume (FEV1)	The change in Forced Expiratory Volume in one second (FEV1) from Baseline to 15 minutes	Forced Expiratory Volume in one second (FEV1) is measured in liters.

Secondary Outcome Measures

Name	Time	Method
Forced Vital Capacity (FVC)	The change in Forced Vital Capacity (FVC) from Baseline to 15 minutes	Forced Vital Capacity (FVC) is measured in liters.

Trial Locations

Locations (1)

UTMB; 🇺🇸 League City, Texas, United States