NCT06779604

Brief Summary

The aim of this study was to investigate the effect of dexmedetomidine and dexamethasone added during USG-guided infraclavicular block on block onset time, total block time and time to first analgesic need in patients undergoing upper extremity surgery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
3mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress54%
Feb 2026Jul 2026

First Submitted

Initial submission to the registry

December 22, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
1 year until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

December 22, 2024

Last Update Submit

February 16, 2026

Conditions

Keywords

infraclavicular nerve blockdexmetomidinedexamethosone

Outcome Measures

Primary Outcomes (3)

  • infraclavicular block onset time

    Sensory block / motor block onset time

    24 -48 hours

  • postoperative analgesic drug requirement

    opioid total amount micrograms

    24 -48 hours

  • infraclavicular total block time

    block time hours

    24 -48 hours

Secondary Outcomes (2)

  • investigate the effects on VAS score and sedation level in the first 24 hours postoperatively

    24 -48 hours

  • advers event Perioperative and postoperative period

    24 -48 hours

Study Arms (2)

Group Dexmedetomidine: (n:22)

A total volume of 30 mL of 0.5% bupivacaine, 14 mL of 2% lidocaine and 50 μgr of dexmedetomidine in 1 mL of normal saline is administered to the patients.

Procedure: Infraclavicular Block with Dexmedetomidine and Dexamethasone

GroupDexamethasone: (n:22)

Patients are administered 0.5% bupivacaine 15 mL, 2% lidocaine 14 mL and 4 mg dexamethasone in 1 ml normal saline with a total volume of 30 mL

Procedure: Infraclavicular Block with Dexmedetomidine and Dexamethasone

Interventions

Infraclavicular block with Dexmedetomidine and Dexamethasone was performed at least 30 min before the start of the operation. The patient was positioned in a supine position arms at the sides or in 90 degree abduction, head turned to the other side. Infraclavicular block was performed with the lateral sagittal technique, while the USG probe was placed under the clavicle and medial to the coracoid process, providing a brachial plexus image in the form of a hyperechoic outer ring and hypoechoic circles, like a classic honeycomb image. A local anesthetic mixture was injected with a 100 mm block needle with negative aspiration and its spread in tissue planes was observed. If the VAS score was 3 or above, tramadol 1 mg kg-1 was administered as an analgesic drug.

Group Dexmedetomidine: (n:22)GroupDexamethasone: (n:22)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 44 adult patients 18 to 70 years, American Society of Anesthesiologists (ASA) I-II who underwent upper extremity surgery were included in Orthopedics and Traumatology Clinic.

You may qualify if:

  • years
  • ASA I-II

You may not qualify if:

  • Under 18 years of age and older than 70 years of age,
  • presence of brachial plexus injury,
  • patients with bleeding diathesis,
  • presence of allergy, -contralateral diaphragmatic paralysis, -
  • presence of nerve injury secondary to trauma,
  • pre-existing neuropathy of the surgical extremity,
  • presence of severe pulmonary,
  • renal and hepatic disease,
  • congestive heart failure (NYHA stage 3-4),
  • uncontrolled diabetes mellitus,
  • history of neuromuscular disease,
  • patients with extreme obesity or malnutrition (BMI \> 30 kg-1m2 or BMI \<20 kg-1m2),
  • presence of epilepsy,
  • history of peripheral vascular disease,
  • history of chronic pain or fibromyalgia,
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umraniye Education and Research Hospital

Istanbul, Umraniye, 34034, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativeAcute Pain

Interventions

DexmedetomidineDexamethasone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • ZELİHA TUNCEL, ASC PROF

    Umraniye ERH

    STUDY DIRECTOR

Central Study Contacts

ZELİHA TUNCEL, ASC PROF

CONTACT

ZELİHA TUNCEL, ASC PROF

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Anesthesia and reanimation

Study Record Dates

First Submitted

December 22, 2024

First Posted

January 16, 2025

Study Start

February 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations