Comparison of 2 Different Methods in Infraclavicular Block

Postoperative Pain Clinical Trial

Official title:

Comparison of 2 Different Methods in Infraclavicular Block

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06402149
• Other study ID #: E1-23-3323
• Status: Enrolling by invitation
• 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
• 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.

Related Conditions & MeSH terms

• Analgesics
• Nerve Block
• Pain, Postoperative
• Postoperative Pain

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

External Links

•   pubmed
•   pubmed