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Safety and Efficacy of Addition of Hyaluronidase to Lidocaine and Bupivacaine in Scalp Nerves Block in Elective Craniotomy Operations, Comparative Study

NCT03411330 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2018-04-27

No results posted yet for this study

Summary

Safety and efficacy of addition of hyaluronidase to lidocaine and bupivacaine in scalp nerves block in elective craniotomy operations,Comparative study

Conditions

  • Addition of Hyalase to Local Anesthetic in Scalp Block

Interventions

DRUG

Hyaluronidase

Scalp nerves block will be done using lidocaine (2%) in a maximum dose of 300 mg and bupivacaine (0.5%) with maximum allowed dose 175 mg in group A, Hyaluronidase will be added in group H in a dose of 1500 IU (The minimum and maximum effective doses of hyaluronidase are not known. The doses used range from0.75 IU/ml to 300 IU/ml

DRUG

Lidocaine

lidocaine (2%) in a maximum dose of 300 mg and bupivacaine (0.5%)

DRUG

Bupivacaine

bupivacaine (0.5%)

Sponsors & Collaborators

  • Mohamed, Ahmed A., M.D.

    collaborator INDIV

  • Tarek Ahmed Radwan

    collaborator UNKNOWN

  • Mohamed Mahmoud Mohamed

    collaborator UNKNOWN

  • Hatem Abdellatif Mohamed

    collaborator UNKNOWN

  • Badawy Mohammed Al-Kholy

    collaborator UNKNOWN

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-24
Primary Completion
2018-04-22
Completion
2018-04-24

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03411330 on ClinicalTrials.gov