Comparison of Efficacy of Bupivacaine in Supraclavicular Block With or Without Dexmedetomidine

NCT05991375 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: SIUT-ERC-2020/PA-257
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

End-stage renal disease (ESRD) patients are coming for Brachial vein transposition surgery. Patients were randomly allocated using sealed opaque envelope bearing A- (Injection bupivacaine (0.25%) 28 ml plus 2 ml. normal saline) and B-Injection bupivacaine (0.25%) 28 mL plus dexmedetomidine I ug/kg diluted to 2 ml). Supraclavicular block under ultrasound and nerve stimulator guidance was performed.

Conditions

Pain

Outcome Measures

Primary Outcomes (3)

• Pain score

  Visual Analogue Scale for pain 0-1-2-3-4-5-6-7-8-9-10 Pain score 0 means no pain, Pain score 1 to 3 means mild pain, Pain score 4-6 means moderate pain, Pain score 7-9 means severe pain, Pain score 10 means most excruciating pain one can have,

  0-4 hours

• Heart rate

  Heart rate as per vitals monitoring device

  0-4 hours

• Mean blood pressure

  as measured by non-invasive blood pressure monitoring device

  0-4 hours

Study Arms (2)

BUPIvacaine 0.25%

ACTIVE COMPARATOR

(Injection bupivacaine (0.25%) 28 ml plus 2 ml. normal saline) making a total volume of local anaesthetic solution equal to 30 mL

Other: saline

Bupivacaine0.25%+DEX

EXPERIMENTAL

Injection bupivacaine (0.25%) 28 mL plus dexmedetomidine I ug/kg diluted to 2 ml) making a total volume of local anaesthetic solution equal to 30 mL

Drug: DEXmedetomidine

Interventions

DEXmedetomidine DRUG

28 mL of Bupivacain 0.25% was mixed with Dexmedetomidine 1 microgram/kg body weight mixed in 2 mL = total volume 30 mL

Also known as: DEX

Bupivacaine0.25%+DEX

saline OTHER

28 mL of Bupivacain 0.25% was mixed with 2 mL of Normal saline = total volume 30 mL

BUPIvacaine 0.25%

Eligibility Criteria

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

You may qualify if:

• Chronic renal failure patients who will undergo elective basilic vein transposition surgery
• Either gender
• ASA III
• Age 18-65 years.

You may not qualify if:

• Mentally challenged
• Pregnancy.
• Hypersensitivity to bupivacaine or dexmedetomidine
• Seizures
• Neck swelling (hematoma, lipoma, tumor, thyroid)
• Neuromuscular dystrophy
• Bleeding disorders

Sponsors & Collaborators

• Sindh Institute of Urology and Transplantation: lead

Study Sites (1)

Syed Muhammad Abbas

Karachi, Sindh, 74200, Pakistan

Location

MeSH Terms

Conditions

Pain

Interventions

Dexmedetomidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Fauzia Ali, FCPS

  Professor Dept of Anaesthesiology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Anaesthesia

Study Record Dates

• First Submitted: July 29, 2023
• First Posted: August 14, 2023
• Study Start: February 15, 2021
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

PA (1)