Comparison of 2 Different Methods in Infraclavicular Block

NCT ID: NCT06402149

Last Updated: 2024-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-10

Study Completion Date

2024-08-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Background :The investigators wanted to see if dexamethasone, which is routinely used as an adjuvant tool by different anesthesiologists in the orthopedics operating room, can really start the effect of other local anesthetics early and prolong the duration of action during infraclavicular block, and giving less additional analgesics after surgery.

Aims:The investigators plan to determine whether this outcome of , dexamethasone which is routinely used as an adjuvant tool to prolong postoperative analgesia.

Methods :60 participants will be included in the study. It includes participants the age of 18, who do not have lung disease such as COPD (Chronic Obstructive Pulmonary Disease), who will undergo infraclavicular block, and who are mentally healthy with ASA I-III.After obtaining written consent from the premedication unit from the participants who were preoperatively evaluated, a vascular access will be opened in the non-operated arm and 0.09% NaCl will be started and 0.05 mg/kg midazolam will be given. All patients will be monitored. With nasal cannula, 3lt/min O2 will be started. 3lt/min O2 will be started with nasal cannula. Patients who underwent infraclavicular block by lateral sagittal method under USG(ultrasound) guidance by adding 2ml dexamethasone (8mg) 3cc 0.9% NaCl to local anesthetic containing 10 ml of bupivacaine (0.5%) and 5cc of prilocaine (2%) will be included in Group I. Patients who underwent infraclavicular block by lateral sagittal method by adding 10 ml of Bupivacaine (0.5%) and 5ml of prilocaine (2%) and 5 cc of 0.9% NaCl will be included in Group II.

ASA score of the patients, drugs used in surgery, name of surgery, age, weight, height, block time, surgery start and end time, pre-block vitals, post-block vitals, adverse effects, sensory and motor block scale, with 10-minute intervals after the block, after the operation. grades immediately after, 12 hours and 24 hours, VAS scoring at 12 and 24 hours after surgery, surgeon satisfaction will be recorded. In addition, morphine and other analgesic consumption will be checked in all patients in the first 24 hours after surgery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Background : The investigators to see if dexamethasone, which is routinely used as an adjuvant tool by different anesthesiologists in the orthopedics operating room, can really start the effect of other local anesthetics early and prolong the duration of action during infraclavicular block, thus enabling the surgery to start early and giving less additional analgesics after surgery.

Aims:The investigators plan to determine whether this outcome of dexamethasone , which is routinely used as an adjuvant tool to prolong postoperative analgesia.

Methods :60 participants will be included in the study. It includes participants over the age of 18, who do not have lung disease such as COPD (Chronic Obstructive Pulmonary Disease), who will undergo infraclavicular block, and who are mentally healthy with ASA I-III.After obtaining written consent from the premedication unit from the participants were preoperatively evaluated, a vascular access will be opened in the non-operated arm and 0.09% NaCl will be started and 0.05 mg/kg midazolam will be given. All participants will be monitored. With nasal cannula, 3lt/min O2 will be started. 3lt/min O2 will be started with nasal cannula. Participants who underwent infraclavicular block lateral sagittal method under USG guidance by adding 2ml dexamethasone (8mg) 3cc 0.9% NaCl to local anesthetic containing 10 ml of bupivacaine (0.5%) and 5cc of prilocaine (2%) will be included in Group I. Participants underwent infraclavicular block by lateral sagittal method by adding 10 ml of Bupivacaine (0.5%) and 5ml of prilocaine (2%) and 5 cc of 0.9% NaCl will be included in Group II.

ASA score of the participants, drugs used in surgery, name of surgery, age, weight, height, block time, surgery start and end time, pre-block vitals, post-block vitals, adverse effects, sensory and motor block scale, with 10-minute intervals after the block, after the operation. grades immediately after, 12 hours and 24 hours, VAS (Visual Analogue Scale) scoring at 12 and 24 hours after surgery, surgeon satisfaction will be recorded.In addition, morphine and other analgesic consumption will be checked in all patients in the first 24 hours after surgery.

At the end of the study, statistical analysis will be made parametrically and non-parametrically through the SPSS 2021 program. Statistics consultancy will be taken when necessary.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain Nerve Block Analgesics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Grup I

Patients who underwent infraclavicular block by lateral sagittal method under USG guidance by adding 2ml dexamethasone (8mg) 3cc 0.9% NaCl to local anesthetic containing 10 ml of bupivacaine (0.5%) and 5cc of prilocaine (2%) will be included in Group I.

dexamethasone

Intervention Type OTHER

Use of dexamethasone in infraclavicular block

Grup II

Patients who underwent infraclavicular block by lateral sagittal method under USG guidance by adding 10 ml of bupivacaine (0.5%) and 5ml of prilocaine (2%) and 5 cc of 0.9% NaCl will be included in Group II.

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

dexamethasone

Use of dexamethasone in infraclavicular block

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

infraclavicular block

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ASA I-III patient group who will undergo upper extremity surgery will be included in the study.

Exclusion Criteria

* Patients under the age of 18 who have lung diseases that will prevent blocking and who are not mentally healthy will not be included in the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Esma M Simsek, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

Hülya Kaşıkara, M.D.

Role: STUDY_DIRECTOR

Ankara City Hospital Bilkent

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ankara Bilkent City Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Gouda N, Zangrilli J, Voskerijian A, Wang ML, Beredjiklian PK, Rivlin M. Safety and Duration of Low-Dose Adjuvant Dexamethasone in Regional Anesthesia for Upper Extremity Surgery: A Prospective, Randomized, Controlled Blinded Study. Hand (N Y). 2022 Nov;17(6):1236-1241. doi: 10.1177/15589447211008558. Epub 2021 Apr 21.

Reference Type BACKGROUND
PMID: 33880959 (View on PubMed)

Pehora C, Pearson AM, Kaushal A, Crawford MW, Johnston B. Dexamethasone as an adjuvant to peripheral nerve block. Cochrane Database Syst Rev. 2017 Nov 9;11(11):CD011770. doi: 10.1002/14651858.CD011770.pub2.

Reference Type BACKGROUND
PMID: 29121400 (View on PubMed)

Simsek EM, Kasikara H. Dexamethasone Added to Mixed Local Anesthetics in Infraclavicular Block: The Dexamethasone Paradox in Chronic Pain. Niger J Clin Pract. 2025 Aug 1;28(8):955-961. doi: 10.4103/njcp.njcp_36_25. Epub 2025 Aug 30.

Reference Type DERIVED
PMID: 40884325 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

E1-23-3323

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.