NCT03660020

Brief Summary

hyalorounidase will be added to local anaesthetics in patients undergoing mastectomy and effect on local anaesthetic spread will be studied under floroscope

Trial Health

43
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 postoperative-pain

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 19, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 9, 2020

Status Verified

April 1, 2020

Enrollment Period

2.5 years

First QC Date

July 20, 2018

Last Update Submit

April 7, 2020

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • degree of local anaesthetics spread after injection in both group

    spread of local anaesthics will be examined under floroscopic guide

    10 minutes after block

Study Arms (2)

local anaesthetic group

SHAM COMPARATOR
Drug: Local anesthetic

hyalorounidase group

ACTIVE COMPARATOR
Drug: Hyaluronidase

Interventions

Local anestheticDRUG

ultrasound guided erector spine plane block (ESP) will be done in patients under going mastectomy with local anaesthetics only

local anaesthetic group
HyaluronidaseDRUG

hyaluronidase will be added to ultrasound guided erector spine plane block (ESP) will be done in patients under going mastectomy

hyalorounidase group

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • ASA I, II, III
  • Elective surgery

You may not qualify if:

  • Patient refusal
  • Infection at injection site
  • Allergy to the given drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, 71111, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthetics, LocalHyaluronoglucosaminidase

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic UsesGlycoside HydrolasesHydrolasesEnzymesEnzymes and CoenzymesPolysaccharide-LyasesCarbon-Oxygen LyasesLyases

Study Officials

  • saeid elsawy

    Assiut University

    STUDY CHAIR

Central Study Contacts

rasha HAMED

CONTACT

088-01000440773rashaahmed11@yahoo.com

saeid elsawy

CONTACT

088-01030072161saeedelsawy17@gmail.com

Study Design

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

Study Record Dates

First Submitted

July 20, 2018

First Posted

September 6, 2018

Study Start

May 19, 2018

Primary Completion

November 1, 2020

Study Completion

December 1, 2020

Last Updated

April 9, 2020

Record last verified: 2020-04

Locations

EG(1)