NCT05183997

Brief Summary

Supraclavicular brachial plexus block (SCBPB) is the common approach to provide surgical anesthesia of upper limb. The effects of single-injection brachial plexus nerve blocks recede after several hours unmasking the moderate to- severe pain of the surgical insult.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Status
unknown

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

First Submitted

Initial submission to the registry

October 8, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

1.1 years

First QC Date

October 8, 2021

Last Update Submit

January 5, 2022

Conditions

Regional Anesthesia Morbidity

Outcome Measures

Primary Outcomes (1)

  • duration of postoperative analgesia.

    blinded observer will collect the Visual Analogue Score (VAS) for pain scored from Zero to ten where 0= no pain and 10 = the worst pain imaginable for acute post-operative pain.

    in first 24 hours

Study Arms (2)

Group (A) : 30 patients (control group):

PLACEBO COMPARATOR

Patient will receive 20 to 30 ml bupivacaine plus 2 ml of normal saline .

Diagnostic Test: complete blood countDiagnostic Test: prothrombin timeDiagnostic Test: prothrombin concentration

Group (B) : 30 patients (verapamil group):

EXPERIMENTAL

Patient will receive 20 to 30 ml bupivacaine plus 5 mg of verapamil diluted in 2 ml of normal saline.

Diagnostic Test: complete blood countDiagnostic Test: prothrombin timeDiagnostic Test: prothrombin concentrationDrug: Verapamil

Interventions

complete blood countDIAGNOSTIC_TEST

laboratory test

Group (A) : 30 patients (control group):Group (B) : 30 patients (verapamil group):
prothrombin timeDIAGNOSTIC_TEST

laboratory test

Group (A) : 30 patients (control group):Group (B) : 30 patients (verapamil group):
prothrombin concentrationDIAGNOSTIC_TEST

laboratory test

Group (A) : 30 patients (control group):Group (B) : 30 patients (verapamil group):
VerapamilDRUG

drug will be add to prolong the effect of regional block

Also known as: Isoptin
Group (B) : 30 patients (verapamil group):

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA I-II patients older than 18years and scheduled for forearm and hand surgeries like :
  • fracture radius and ulna.
  • cut wrists.

You may not qualify if:

  • allergy to the study drugs,
  • skin infection at site of needle puncture,
  • significant organ dysfunction, coagulopathy, drug or alcohol abuse, epilepsy, and psychiatric illness that would interfere with perception and assessment of pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Choi S, Rodseth R, McCartney CJ. Effects of dexamethasone as a local anaesthetic adjuvant for brachial plexus block: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2014 Mar;112(3):427-39. doi: 10.1093/bja/aet417. Epub 2014 Jan 10.

    PMID: 24413428BACKGROUND

  • Knezevic NN, Anantamongkol U, Candido KD. Perineural dexamethasone added to local anesthesia for brachial plexus block improves pain but delays block onset and motor blockade recovery. Pain Physician. 2015 Jan-Feb;18(1):1-14.

    PMID: 25675053BACKGROUND

  • Popping DM, Elia N, Marret E, Wenk M, Tramer MR. Clonidine as an adjuvant to local anesthetics for peripheral nerve and plexus blocks: a meta-analysis of randomized trials. Anesthesiology. 2009 Aug;111(2):406-15. doi: 10.1097/ALN.0b013e3181aae897.

    PMID: 19602964BACKGROUND

  • Malmberg AB, Yaksh TL. Voltage-sensitive calcium channels in spinal nociceptive processing: blockade of N- and P-type channels inhibits formalin-induced nociception. J Neurosci. 1994 Aug;14(8):4882-90. doi: 10.1523/JNEUROSCI.14-08-04882.1994.

    PMID: 8046458BACKGROUND

  • Brose WG, Gutlove DP, Luther RR, Bowersox SS, McGuire D. Use of intrathecal SNX-111, a novel, N-type, voltage-sensitive, calcium channel blocker, in the management of intractable brachial plexus avulsion pain. Clin J Pain. 1997 Sep;13(3):256-9. doi: 10.1097/00002508-199709000-00012.

    PMID: 9303259BACKGROUND

MeSH Terms

Interventions

Blood Cell CountProthrombin TimeVerapamil

Intervention Hierarchy (Ancestors)

Cell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaBlood Coagulation TestsPhenethylaminesEthylaminesAminesOrganic Chemicals

Central Study Contacts

Essam Sharkawy, MD

CONTACT

00201223497642essamsas@yahoo.com

Abdelraheem Mahmoud, MD

CONTACT

00201000032655arawamyyy@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 8, 2021

First Posted

January 11, 2022

Study Start

January 1, 2022

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

January 11, 2022

Record last verified: 2022-01