Out of Plane Approach for Interscalene

Acute Pain Clinical Trial

Official title:

Out of Plane Approach for Interscalene Level Brachial Plexus Block to Avoid Phrenic Nerve Involvement - a Prospective Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03785392
• Other study ID #: 17-0121
• Status: Terminated
• Phase: N/A
• Start date: March 29, 2019
• Est. completion date: December 8, 2019

Study information

• Verified date: October 2020
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: December 8, 2019
• Est. primary completion date: December 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Brachial Plexus Block

Intervention

Procedure:
• Group 1 In-plane
Group 1: Study will involve total of 15 patients with the procedure done in-plane. Before the block placement and after the block placement lung function will be measured. FEV1 (forced expiratory volume in 1 second ) and FVC ( forced vital Capacity ) values will be recorded. Block will be performed in plane and postprocedure lung function test will be repeated. New values of FEV1 and FVC will be obtained after the placement of the nerve block.
• Group 2 out of plane
Group 2 study will adopt the out of plane technique and will involve a total of 15 patients in this group. We will do the procedure out of plane and will have lung function FEV1 and FVC measured bedside.FEV1 and FVC values will be recorded. Block will be performed out of plane and postprocedure lung function test will be measured. New values of FEV1 and FVC will be obtained

Locations

Country	Name	City	State
United States	UTMB	Galveston	Texas
United States	UTMB	League City	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced Expiratory Volume (FEV1)	Forced Expiratory Volume in one second (FEV1) is measured in liters.	The change in Forced Expiratory Volume in one second (FEV1) from Baseline to 15 minutes
Secondary	Forced Vital Capacity (FVC)	Forced Vital Capacity (FVC) is measured in liters.	The change in Forced Vital Capacity (FVC) from Baseline to 15 minutes