MINIMUM EFFECTIVE VOLUME OF BUPIVACAİNE FOR ANTERIOR SUPRASCAPULAR NERVE BLOCK

July 15, 2022 updated by: Sami Kaan Coşarcan, V.K.V. American Hospital, Istanbul

MINIMUM EFFECTIVE AND MAXIMUM DIAPHRAGM-SPARING VOLUME OF BUPIVACAİNE FOR ULTRASOUND GUIDED ANTERIOR SUPRASCAPULAR NERVE BLOCK

Various local anesthetic volumes are used in the literature for anterior suprascapular nerve block (ASSB). There are different studies between 15 ml and 5 ml. Effective local anesthetic volume studies for ASSB have not yet been performed. Our study is aimed to investigate the minimum effective local anesthetic volume for ASSB.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Peripheral nerve blockade reduces pain scores and opioid consumption and increases patient satisfaction within the first 24 h after shoulder surgery. In the absence of neuraxial and peripheral nerve blocks, opioid consumption after shoulder surgery has been purported to rival the one recorded for thoracotomy. Interscalene brachial plexus blocks (ISBB) constitute the gold standard for analgesia after shoulder procedures. Compared with parenteral opioids, ISBB results in lower pain scores improved patient satisfaction [4]. ISBB is highly utilized in clinical practice as it provides anesthesia and analgesia to the shoulder and lateral aspects of the arm and the forearm, reducing opioid consumption and subsequent opioid-related adverse effects [5]. However, ISB is associated with numerous complications and adverse effects3 such as phrenic nerve palsy (100%), recurrent laryngeal nerve block (3 - 21%), stellate ganglion block (5 - 75%) (Horner's syndrome), spinal (0.4 - 4%) and epidural anesthesia (2.2%), and convulsions (0.2 - 3%) at standard volumes of 20 - 30 ml. Phrenic nerve block is associated with significant reductions in ventilatory function including a 21 - 34% decrease in forced vital capacity (FVC), 17 - 37% decrease in forced expiratory volume, and 15.4% decrease in peak expiratory flow rate. The most common adverse effect after ISB remains the occurrence of ipsilateral phrenic nerve block. Although well tolerated by healthy subjects, HDP becomes a prohibitive risk for patients with pulmonary pathology, who may be unable to withstand the 30% reduction in FVC. Viable diaphragm-sparing alternatives to ISB should achieve three separate and distinct goals: adequate surgical anesthesia (without general anesthesia), adequate postoperative analgesia, and low incidence of HDP. Alternative nerve blocks are performed in shoulder surgery to prevent HDP. Therefore, different approaches such as suprascapular nerve block, costoclavicular block, shoulder block, supraclavicular block, combined infraclavicular and suprascapular block, which are defined as diaphragm sparing blocks, are recommended.

Our study aimed to investigate the minimum effective local anesthetic volume in postoperative analgesia of the anterior suprascapular nerve block (ASSB) and the maximum local anesthetic volume that can be diaphragm-sparing. Our secondary aim is to reveal an important parameter in the diaphragm sparing nerve blocks. The volume of a local anesthetic to be administered should be expected to have a common volume that is the most effective and protects the diaphragm. We envisioned that this should be defined as the minimum target-specific volume (MTsV).

Adults (over 18 years of age) with the American Society of Anesthesiologists Physical Condition classification I to III who are scheduled to undergo unilateral ambulatory arthroscopic shoulder surgery under general anesthesia will be included in the study. Written informed consent will be obtained from all study subjects before participation in this study. Surgical procedures are planned to include shoulder arthroscopy, rotator cuff repair, acromioplasty, Bankart repair, and superior labrum anterior-posterior repair. Patients with a history of serious broncho-pulmonary disease, known phrenic nerve pathology, existing neurological deficits or neuropathy involving the brachial plexus on the surgical side, contraindications to nerve blocks (infection, bleeding diathesis, allergy to local anesthetics), or history will be excluded from the study. A full pre-operative evaluation will be performed with the necessary laboratories the day before the surgery, and written informed consent will be obtained.

The 0.5% initial injected volume of bupivacaine was 10 mL, providing a complete sensory block of anterior suprascapular nerve block based on our clinical experience. According to the Dixon and Massey [10] up-down method, the 0.5% bupivacaine volume used for a given patient was determined by the result of the previous block, as defined above as block success. Once effective ASSB is achieved, the volume of bupivacaine 0.5% to the next patient will be reduced by 1 mL. Conversely, in case of block failure, the volume of 0.5% bupivacaine will be increased by 1 mL in the next patient.

An independent observer will assess ipsilateral hemidiaphragmatic motion by real-time M-mode ultrasonography using a 1 to 5 MHz broadband phased array US probe (Philips CX50). Patients were examined in an upright sitting position and scanned from a low intercostal or subcostal approach using the liver or spleen as the acoustic window. The range of diaphragm movement from the resting expiratory position to deep inspiration (sigh test) and the range of diaphragm movement from the resting expiratory position when quickly inhaling through the nose (sniffing test) will be recorded. More than 75% hemidiaphragmatic movement reduction, no movement, or paradoxical movement will be considered complete paresis. Between 25% and 75%, hemidiaphragmatic movement decrease was considered partial paresis, and less than 25% hemidiaphragmatic movement decrease paresis was considered absent. The movement of the diaphragm will be measured in centimeters. The normal caudal movement was positive (+), paradoxical head movement was negative (-). Each test will be performed three times, and the values will be averaged. All measurements will be made before (beginning) and 30 minutes after the block.

Fifty minutes after the block performance, general anesthesia will be given using a standard protocol of intravenously administered propofol 2 mg/kg, Fentanyl 1 ug/kg, and rocuronium 0.6 mg/kg. Pain scores of the patients will be recorded for 48 hours postoperatively.

Study Type

Observational

Enrollment (Actual)

67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Amerikan Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Age greater than 18 years with American Society of Anesthesiologists Physical Status classification I to III scheduled to undergo unilateral arthroscopic shoulder surgery patients under general anesthesia.

Description

Inclusion Criteria:

  • adults (age greater than 18 yr) with American Society of Anesthesiologists Physical Status classification I to III scheduled to undergo unilateral arthroscopic shoulder surgery under general anesthesia

Exclusion Criteria:

  • dementia
  • chronic opioid consumption
  • chronic pain disease
  • chronic obstructive pulmonary disease
  • history of serious lung disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Anterior suprasscapular nerve block
A single researcher will perform the nerve blocks of all participants.
Procedure: anterior supra scapular nerve block
nerve block for postoperative pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative analgesia
Time Frame: postoperative 48 hours
minimum effective local anesthetic volume in postoperative analgesia of the anterior suprascapular nerve block (ASSB) and the maximum local anesthetic volume that can be diaphragm-sparing.
postoperative 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diaphragm sparing nerve block
Time Frame: 0 and 30 min after the nerve block
The volume of local anesthetic to be administered should be expected to have a common volume that is the most effective and protects the diaphragm. We envisioned that this should be defined as the minimum target-specific volume (MTsV).
0 and 30 min after the nerve block

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

V.K.V. American Hospital, Istanbul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2022

Primary Completion (Actual)

June 3, 2022

Study Completion (Actual)

July 13, 2022

Study Registration Dates

First Submitted

February 7, 2022

First Submitted That Met QC Criteria

February 7, 2022

First Posted (Actual)

February 16, 2022

Study Record Updates

Last Update Posted (Actual)

July 18, 2022

Last Update Submitted That Met QC Criteria

July 15, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cosarcan1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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