NCT04921891

Brief Summary

The infraclavicular nerve block, which is frequently preferred in upper extremity surgeries, provides additional advantages such as reduction in opioid consumption by providing analgesic effect in the postoperative period as welll. The success of peripheral nerve blocks is usually assessed by subjective feedback from the patient, and patient cooperation is needed. The aim of this study is to assess whether the perfusion index level, which can be measured noninvasively, can be a predictor of the infraclavicular block success.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2014

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2021

Completed
Last Updated

June 10, 2021

Status Verified

June 1, 2021

Enrollment Period

Same day

First QC Date

June 1, 2021

Last Update Submit

June 4, 2021

Conditions

Keywords

Infraclavicular blockPerfusion indexUltrasonographyBlock assessment

Outcome Measures

Primary Outcomes (1)

  • Evaluation of whether perfusion index is a reliable and objective method to indicate block success

    Perfusion index was measured up to 6 hours after the procedure.

    6 hours postprocedurly

Secondary Outcomes (1)

  • Determining of a cut-off value for PI and PI ratio for a successful block.

    Up to 6 hours after the procedure

Study Arms (2)

Blocked arm

ACTIVE COMPARATOR

The investigators performed an infraclavicular nerve block to the operated arm group to provide anesthesia.

Procedure: Infraclavicular nerve block

Unblocked arm

ACTIVE COMPARATOR

The upper extremity without block was assigned as the control group, and a comparison was made between the two upper extremities.

Procedure: Without nerve block

Interventions

The investigators performed an infraclavicular nerve block to the operated arm group to provide anesthesia.

Blocked arm

The upper extremity without block was assigned as the control group, and a comparison was made between the two upper extremities.

Unblocked arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages of 18-75
  • Patients who will diagnose with carpal tunnel syndrome by electroneuromyography (ENMG), and will undergo unilateral surgery under elective conditions
  • ASA I-II-III patients

You may not qualify if:

  • Patients who will refuse this method
  • Neurological deficits,
  • Diabetes mellitus,
  • Local anesthetic allergy,
  • Morbidly obese,
  • Peripheral vascular disease, coronary artery disease, or coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Istanbul, Bakirkoy, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Nerve Block

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 1, 2021

First Posted

June 10, 2021

Study Start

April 15, 2014

Primary Completion

April 15, 2014

Study Completion

October 30, 2014

Last Updated

June 10, 2021

Record last verified: 2021-06

Locations