NCT04508894

Brief Summary

Intervention model description: The patients were randomly classified into three groups using computer-generated table numbers each contain (25) patients. Ketamine group (group K): 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline plus 1 mg\\kg ketamine, Dexmedetomidine group (group D): 20 ml 0.5% bupivacaine and 20 ml 0.9% normal saline plus 1µg\\kg dexmedetomidine Control group (group C): 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline. Masking: double-blind (participant and investigator) Masking Description: The investigator's study is a prospective, randomized, double-blind

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

1.7 years

First QC Date

August 2, 2020

Last Update Submit

July 29, 2023

Conditions

Supraclavicular Brachial Plexus Block

Outcome Measures

Primary Outcomes (1)

  • Evaluate duration of sensory block

    Sensory block duration: the time interval between the complete sensory block and complete resolution by hours

    24 hours after block

Secondary Outcomes (5)

  • Evaluate onset of sensory and motor block

    30 minute after block

  • Assess postoperative pain score

    For 24 hours after surgery

  • time to first analgesic request

    24 hours

  • total analgesic requirements

    24 hours after surgery

  • sedation score

    24 hours after surgery

Study Arms (3)

Control group

PLACEBO COMPARATOR

Supraclavicular Brachial Plexus Block using 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline

Drug: Supraclavicular Brachial Plexus Block with bupivacaine

Ketamine group

ACTIVE COMPARATOR

Supraclavicular Brachial Plexus Block using 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline plus 1 mg\\kg ketamine

Drug: Supraclavicular Brachial Plexus Block with Ketamine

Dexmedetomidine group

ACTIVE COMPARATOR

Supraclavicular Brachial Plexus Block using 20 ml 0.5% bupivacaine and 20 ml 0.9% normal saline plus 1µg\\kg dexmedetomidine

Drug: Supraclavicular Brachial Plexus Block with Dexmedetomidine

Interventions

Supraclavicular Brachial Plexus Block with bupivacaineDRUG

drug: 20 ml 0.5%bupivacaine plus 20 ml 0.9% normal saline is administered around the brachial plexus on the operative side Drug: IM diclofenac sodium (75 mg amp) is injected if VAS more than 4. Device: ultrasound-guided supraclavicular Brachial Plexus nerve block

Also known as: C group
Control group
Supraclavicular Brachial Plexus Block with KetamineDRUG

drug: 20 ml 0.5%bupivacaine, 20 ml 0.9% normal saline plus 1mg\\kg ketamine is administered around the brachial plexus on the operative side Drug: IM diclofenac sodium (75 mg amp) is injected if VAS more than 4. Device: ultrasound-guided supraclavicular Brachial Plexus nerve block

Also known as: K group
Ketamine group
Supraclavicular Brachial Plexus Block with DexmedetomidineDRUG

drug: 20 ml 0.5%bupivacaine, 20 ml 0.9% normal saline plus 1µg\\kg dexmedetomidine is administered around the brachial plexus on the operative side Drug: IM diclofenac sodium (75 mg amp) is injected if VAS more than 4. Device: ultrasound-guided supraclavicular Brachial Plexus nerve block

Also known as: D group
Dexmedetomidine group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Physical Status I or II
  • patients undergoing elective and emergency forearm and hand surgeries

You may not qualify if:

  • Patient with bleeding disorders
  • Damage or disease of the brachial plexus
  • Uncontrolled diabetes mellitus
  • Patients with neuromuscular diseases
  • Patients with a local skin infection at the site of injection
  • Patients with known hypersensitivity to studied drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minya University

Minya, 61519, Egypt

Location

MeSH Terms

Interventions

BupivacaineKetamineDexmedetomidine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Haidy S Mansour, MD

    assistant professor of Anesthesia and Surgical Intensive Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 2, 2020

First Posted

August 11, 2020

Study Start

April 21, 2019

Primary Completion

December 28, 2020

Study Completion

December 30, 2020

Last Updated

August 1, 2023

Record last verified: 2023-07

Locations

EG(1)