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Out of Plane Approach for Interscalene

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Terminated

Conditions

Brachial Plexus Block
Acute Pain

Treatments

Procedure: Group 1 In-plane
Procedure: Group 2 out of plane

Study type

Interventional

Funder types

Other

Identifiers

NCT03785392
17-0121

Details and patient eligibility

About

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

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups

Group 1 Inplane
Active Comparator group
Description:
Study with the technique Inplane group
Treatment:
Procedure: Group 1 In-plane
Group 2 out of plane
Active Comparator group
Description:
Study with the technique out of plane
Treatment:
Procedure: Group 2 out of plane

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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