Comparison of 2 Different Methods in Infraclavicular Block

NCT06402149 | Enrolling By Invitation DMC

• 1 other identifier: E1-23-3323
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain; Nerve Block; Analgesics

Keywords

infraclavicular block; VAS (Visual Analogue Scale) score; dexamethasone

Outcome Measures

Primary Outcomes (1)

• Analgesia duration

  A comparison will be made in both groups by looking at the sensory block onset time and the time between the patient's first analgesia request.

  24 hours

Secondary Outcomes (1)

• Morphine other analgesics consumption

  24 hours

Study Arms (2)

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.

Other: dexamethasone

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.

Interventions

dexamethasone OTHER

Use of dexamethasone in infraclavicular block

Also known as: infraclavicular block

Grup I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

60 patients will be included in the study. It includes patients over the age of 18, who do not have lung disease such as COPD, who will undergo infraclavicular block, and who are mentally healthy with ASA I-III.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 33880959 BACKGROUND

• 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.

  PMID: 29121400 BACKGROUND

• 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.

  PMID: 40884325 DERIVED

Related Links

• pubmed
• pubmed

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Esma M Simsek, M.D.

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

• Hülya Kaşıkara, M.D.

  Ankara City Hospital Bilkent

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 7, 2024
• Study Start: March 10, 2023
• Primary Completion: August 10, 2024
• Study Completion: August 16, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)