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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06402149
Other study ID # E1-23-3323
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date March 10, 2023
Est. completion date August 16, 2024

Study information

Verified date May 2024
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 60
Est. completion date August 16, 2024
Est. primary completion date June 10, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Other:
dexamethasone
Use of dexamethasone in infraclavicular block

Locations

Country Name City State
Turkey Ankara Bilkent City Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Morphine other analgesics consumption The morphine and other analgesics consumption will be measured in all patients in the first 24 hours after surgery. 24 hours
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