The Need for Supplemental Blocks in Infraclavicular Brachial Plexus Blocks

Sponsor
Derince Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04102358
Collaborator
(none)
139
1
19.9
7

Study Details

Study Description

Brief Summary

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 (1). In this study, we aimed to evaluate the single injection and triple injection techniques in IC blocks with USG-guided medial approach, in terms of block success and the need for supplementary blocks. Our secondary goals are to compare the complication rates, sensory block durations, and to discuss the possible reasons for the failure of the blocks.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Medial approach infraclavicular block with single injection
  • Procedure: Medial approach infraclavicular block with triple injection

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, we aimed to evaluate the single injection and triple injection techniques in IC blocks with USG-guided medial approach, in terms of block success and the need for supplementary blocks. Our secondary goals are to compare the complication rates, 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 technique used for infraclavicular brachial plexus blocks (lateral sagittal, coracoid, …etc.), and known allergy to local anesthetic drugs.

Study Design

Study Type:
Observational
Actual Enrollment :
139 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Need for Supplemental Blocks in Single Versus Triple Injections in Infraclavicular Brachial Plexus Blocks With Medial Approach: A Clinical and an Anatomical Study
Actual Study Start Date :
Oct 1, 2017
Actual Primary Completion Date :
Mar 31, 2019
Actual Study Completion Date :
May 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Single injection

Patients who received an infraclavicular block with a single injection technique were included in Group-S.

Procedure: Medial approach infraclavicular block with single injection
infraclavicular blocks performed with single injection

Triple injection

Patients who received an infraclavicular block with a triple injection technique were included in Group-T.

Procedure: Medial approach infraclavicular block with triple injection
infraclavicular blocks performed with triple injection

Outcome Measures

Primary Outcome Measures

  1. Supplemented blocks [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.

Secondary Outcome Measures

  1. Complete Failure [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.

  2. Recovery of sensory block [24 hours]

    the first time of the need for analgesics

  3. Discomfort during IC block [1 hour]

    paresthesia during the infraclavicular block

  4. Inadvertent vascular puncture [1 hour]

    inadvertent vascular puncture during the infraclavicular block

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Derince Training and Research Hospital Kocaeli Derince Turkey 41900

Sponsors and Collaborators

  • Derince Training and Research Hospital

Investigators

  • Study Chair: Tuncay Colak, Prof, Kocaeli University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hande G. Aytuluk, MD, Derince Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04102358
Other Study ID Numbers:
  • U1111-1240-8832
First Posted:
Sep 25, 2019
Last Update Posted:
Sep 25, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hande G. Aytuluk, MD, Derince Training and Research Hospital

Study Results

No Results Posted as of Sep 25, 2019