Efficacy and Safety of Dexmedetomidine to Bupivacaine in Supraclavicular Brachial Plexus Block

Dexmedetomidine Clinical Trial

Official title:

Efficacy and Safety of Dexmedetomidine to 20ml Bupivacaine in Supraclavicular Brachial Plexus Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06020781
• Other study ID #: KFSIRB200-51
• Status: Completed
• Phase: N/A
• Start date: October 9, 2023
• Est. completion date: March 11, 2024

Study information

• Verified date: March 2024
• Source: Kafrelsheikh University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to evaluate the analgesic efficacy and safety of addition of 1µg/kg dexmedetomidine to 20ml bupivacaine compared to 20ml and 30ml bupivacaine without additives in ultrasound-guided supraclavicular brachial plexus block for anesthesia.

Description:

Dexmedetomidine, a highly selective α2 adrenergic agonist, has been used as an adjuvant to local anesthetics. Various clinical trials performed have shown dexmedetomidine to be safe when used as an adjuvant to local anesthetic in subarachnoid, caudal, and epidural Different doses of dexmedetomidine are commonly used as an additive in Ultrasound-guided supraclavicular brachial plexus block, 1 μg/kg and 2 μg/kg in which a high dose of dexmedetomidine does not prolong the duration of analgesia, but it is associated with lower heart rate and blood pressure. Incidence of hypotension and bradycardia is also more. Hence, a lower dose of 1 μg/kg dexmedetomidine is a good balance between safety and efficacy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 11, 2024
• Est. primary completion date: March 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologist (ASA) grade I or II patients
• both sexes
• scheduled for elective upper limb surgery below mid-humerus level under Ultrasound -guided Supraclavicular brachial plexus block .

Exclusion Criteria:

• with pre-existing peripheral neuropathy of upper limb.
• Bleeding disorders.
• Infection at injection site.
• Untreated pneumothorax.
• Patients on adrenoreceptor agonist or antagonist therapy.
• History of severe cardiac,.respiratory, hepatic, or renal disease.
• pregnancy and known hypersensitivity to the study drugs.

Related Conditions & MeSH terms

• Bupivacaine
• Dexmedetomidine
• Supraclavicular Brachial Plexus Block

Intervention

Drug:
• bupivacaine and dexmedetomidine.
patient will receive Ultrasound -guided Supraclavicular brachial plexus block with 20 ml bupivacaine 0.5% + 1 µg/kg dexmedetomidine.
• bupivacaine only
patient will receive Ultrasound -guided Supraclavicular brachial plexus block with 20 ml bupivacaine 0.5% without additives
• bupivacaine
patient will receive Ultrasound -guided Supraclavicular brachial plexus block with 30 ml bupivacaine 0.5% without additives as a control group.

Locations

Country	Name	City	State
Egypt	Kafrelsheikh University	Kafr Ash Shaykh	Kafrelsheikh

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate.	Sensory and motor block evaluation will be done every 3 min after giving the block until complete sensory and motor block or 30 min, whichever will be earlier.	30 minutes after block performance
Secondary	Total pethidine consumption.	Visual analog scale = 4 indicates the analgesic requirements. The patient will be given supplementary pethidine I.V. injection in a dose of 0.5 mg as rescue analgesia. Total pethidine consumption postoperative in the 1st 24 hours will be measured.	24 hours postoperative.
Secondary	Pain score.	Pain score will be measured by visual analogue scale (VAS) at 30 minutes and then at 2, 4, 6, 12, 18 and 24 hours postoperative.; The VAS consists of a 10cm line, with two end points representing 0 (no pain) and 10 (pain as bad as it could possibly be).	24 hours postoperative.
Secondary	Mean arterial blood pressure	Mean arterial blood pressure from preoperatively, after block, then every 15 minutes intraoperative till the end of surgery.	From preoperatively till the end of surgery
Secondary	Heart rate	Heart rate from preoperatively, after block, then every 15 minutes intraoperative till the end of surgery.	From preoperatively till the end of surgery
Secondary	Postoperative side effects.	Complication related to the block or adverse events of the administered drugs.	24 hours postoperative