NCT04729868

Brief Summary

To evaluate the efficacy of levo-bupivacaine alone and with dexmedetomidine in Ultrasound guided infraclavicular brachial plexus block for hand and forearm surgeries as regard: Onset of sensory and motor blockade. Duration of sensory and motor blockade. Analgesic pain scores using the verbal rating scale (VRS) for pain. Duration of analgesia postoperative complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

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 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 29, 2021

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

3 years

First QC Date

January 7, 2021

Last Update Submit

January 27, 2021

Conditions

Acquired Deformity of ElbowForearmHandWrist

Outcome Measures

Primary Outcomes (4)

  • Onset time of sensory block in minutes

    After the injection of the solution, every patient was checked for the onset of sensory blockade using goose soaked with iced normal saline by the following scale (three-point scale): Grade 0= perceived as normal sensation, Grade 1 = loss of cold sensation (analgesia), Grade 2= loss of sensation of touch (anesthesia).

    45 minutes

  • onset time of motor blockade in minutes using the modified Bromage scale (Three-point scale)

    the modified Bromage scale (Three-point scale): Grade 0: Normal motor function, Grade 1: Decreased motor strength with the ability to move the fingers only, Grade 2: Complete motor block with an inability to move the fingers.

    24 hours

  • Duration of sensory block in hours

    It's the time from sensory block onset to the time of restoration of sensation at the surgical site

    24 hours

  • Duration of motor block in hours

    It's the time from motor block onset to the restoration of global mobility in the hand and the wrist.

    24 hours

Secondary Outcomes (5)

  • Visual analog scale (VAS)

    24 hours

  • Postoperative first analgesic request time in hours

    24 hours

  • Mean blood pressure in mmHg

    24 hours

  • heart rate in beats / minute

    24 hours

  • peripheral oxygen saturation

    24 hours

Study Arms (3)

group Levo-bupivacaine

OTHER

Group A (20 patients): Anesthesia will be performed with 35 ml of 0.5% levo-bupivacaine plus 1ml normal saline under the guidance of ultrasound for infraclavicular brachial plexus block.

Drug: Levobupivacaine(chirocaine) plus dexmedetomidine(precedex)

group levo-bupivacaine plus 50µg dexmedetomidine

OTHER

Group B (20 patients): Anesthesia will be performed with 35 ml of 0.5% levo-bupivacaine plus 50µg dexmedetomidine under the guidance of ultrasound for infraclavicular brachial plexus block.

Drug: Levobupivacaine(chirocaine) plus dexmedetomidine(precedex)

group levo-bupivacaine plus 100µg dexmedetomidine

OTHER

Group C (20 patients): Anesthesia will be performed with 35 ml of 0.5% levo-bupivacaine plus 100µg dexmedetomidine under the guidance of ultrasound for infraclavicular brachial plexus block.

Drug: Levobupivacaine(chirocaine) plus dexmedetomidine(precedex)

Interventions

Levobupivacaine(chirocaine) plus dexmedetomidine(precedex)DRUG

evaluate the efficacy of levo-bupivacaine alone and with dexmedetomidine in Ultrasound guided infraclavicular brachial plexus block for hand and forearm surgeries

Also known as: the efficacy of levo-bupivacaine alone and with dexmedetomidine in Ultrasound guided infraclavicular brachial plexus block for hand and forearm surgeries
group Levo-bupivacainegroup levo-bupivacaine plus 100µg dexmedetomidinegroup levo-bupivacaine plus 50µg dexmedetomidine

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 20-65 years old.
  • American society of anesthesiologist physical status (ASA): I-II.
  • Operation: forearm \& hand surgeries.

You may not qualify if:

  • Patients with chronic pain
  • Those using chronic analgesic medications
  • History of brachial plexus injury
  • Allergy to the study drugs
  • Hepatic or renal insufficiency or infection at the site of injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zaher

Cairo, Egypt

Location

Related Publications (1)

  • Ghazaly HF, Aly AAA, Zaher ZZ, Hassan MM, Mahmoud AA. Comparison of the efficacy of two doses of dexmedetomidine as an adjunct to levobupivacaine in infraclavicular brachial plexus block: prospective double-blinded randomized controlled trial. BMC Anesthesiol. 2022 Nov 5;22(1):338. doi: 10.1186/s12871-022-01858-4.

    PMID: 36335297DERIVED

Study Design

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

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 29, 2021

Study Start

April 1, 2017

Primary Completion

April 1, 2020

Study Completion

October 1, 2020

Last Updated

January 29, 2021

Record last verified: 2021-01

Locations

EG(1)