The Need for Supplemental Blocks in Infraclavicular Brachial Plexus Blocks

February 16, 2024 updated by: Hande Gurbuz, Derince Training and Research Hospital

The Need for Supplemental Blocks in Single Versus Triple Injections in Infraclavicular Brachial Plexus Blocks With Medial Approach: A Clinical and an Anatomical Study

Theoretically, all surgeries below mid-humerus can be done under infraclavicular (IC) blocks. Following the introduction of ultrasonography (USG) to clinical anesthesia, plexus, and nerve blocks under the guidance of USG have gained wide acceptance for the high rates of block success and low risk of complications (1). In this study, the main aim is to evaluate the single injection and triple injection techniques in IC blocks with a USG-guided medial approach in terms of block success and the need for supplementary blocks. The secondary goals are to compare the complication rates and sensory block durations and to discuss the possible reasons for the failure of the blocks.

Study Overview

Detailed Description

Theoretically all surgeries below mid-humerus can be done under infraclavicular (IC) blocks. Following the introduction of ultrasonography (USG) to the clinical anesthesia, plexus and nerve blocks under the guidance of USG have gained wide acceptance for the high rates of block success, and low risk of complications. At the same time, it was also shown that USG-guided IC blocks can shorten procedural times and accelerate the onset of the blocks.

Several methods for IC blocks have been described. Based on the anatomical knowledge, we hypothesized that in medial approaches the need for supplementary blocks would be low with single injections as well as triple injections. In this study, the main aim is to evaluate the single injection and triple injection techniques in IC blocks with a USG-guided medial approach in terms of block success and the need for supplementary blocks. The secondary goals are to compare the complication rates and sensory block durations and to discuss the possible reasons for the failure of the blocks.

Medical records of 139 patients scheduled for elective or emergent hand, wrist, forearm, elbow, and distal arm surgery were analyzed. Patients older than 14 years with ASA physical status I-III who underwent surgery between October 2017 and March 2019 were retrospectively evaluated. Exclusion criteria included non-cooperative patients, refusal of the regional anesthesia, known neuropathy that could prevent the evaluation of the efficacy of the block, different techniques used for infraclavicular brachial plexus blocks (lateral sagittal, coracoid, …etc.), and known allergy to local anesthetic drugs.

Study Type

Observational

Enrollment (Actual)

139

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

    • Derince
      • Kocaeli, Derince, Turkey, 41900
        • Derince Training and Research Hospital

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

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients underwent surgery for upper extremity under medial approach infraclavicular block between October 2017 and March 2019

Description

Inclusion Criteria:

  • ASA physical status I-III
  • upper extremity surgery
  • blocks were performed by the same anesthesiologist

Exclusion Criteria:

  • non-cooperative patients
  • refusal of the regional anesthesia
  • known neuropathy
  • different technique used for infraclavicular brachial plexus blocks (lateral sagittal, coracoid, …etc.)
  • known allergy to local anesthetic drugs.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single injection
Patients who received an infraclavicular block with a single injection technique were included in Group-S.
infraclavicular blocks performed with single injection
Triple injection
Patients who received an infraclavicular block with a triple injection technique were included in Group-T.
infraclavicular blocks performed with triple injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Supplemented blocks
Time Frame: 1 hour
30 minutes after the block, if one or two of the median, radial, ulnar or musculocutaneous nerves were still unblocked, these nerves were located either with a peripheric nerve stimulator or an ultrasound, in the axilla or on the more distal parts of their traces on arm and forearm and then supplemented.
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Failure
Time Frame: 30 minutes
If more than two of these nerves (median, radial, ulnar or musculocutaneous) were remained unblocked, no supplementary blocks were applied, then it was considered as having a failed block and general anesthesia was administered.
30 minutes
Recovery of sensory block
Time Frame: 24 hours
the first time of the need for analgesics
24 hours
Discomfort during IC block
Time Frame: 1 hour
paresthesia during the infraclavicular block
1 hour
Inadvertent vascular puncture
Time Frame: 1 hour
inadvertent vascular puncture during the infraclavicular block
1 hour

Collaborators and Investigators

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

Investigators

  • Study Chair: Tuncay Colak, Prof, Kocaeli University

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.

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)

October 1, 2017

Primary Completion (Actual)

March 31, 2019

Study Completion (Actual)

May 30, 2019

Study Registration Dates

First Submitted

September 23, 2019

First Submitted That Met QC Criteria

September 23, 2019

First Posted (Actual)

September 25, 2019

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • U1111-1240-8832

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available.

IPD Sharing Time Frame

Data will be available within 6 months of study completion.

IPD Sharing Access Criteria

Data access requests will be reviewed by the researchers. Requestors will be required to sign a Data Access Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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