Addition of Neostigmine to Levobupivacaine | NCT04492319

Studies
Addition of Neostigmine to Levobupivacaine

NCT04492319

Sponsor

Cairo University

Status

Completed

Last Update Posted

Jan 9, 2024Actual

Enrollment

112Actual

Phase

Not Applicable

Conditions

Spermatic Cord Block

Interventions

Control Test
Neostigmine

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 29, 2020Actual

Primary Completion Date

Nov 23, 2023Actual

Completion Date

Dec 20, 2023Actual

First Submitted Date

Jun 3, 2020

First Submission Date that Met QC Criteria

Jul 28, 2020

First Posted Date

Jul 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2024

Last Update Posted Date

Jan 9, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amr Samir Wahdan, Lecturer of Anesthesia, Pain management and Surgical ICU, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Using the spermatic cord block has been of great advantage, as it has been cost saving, efficient technique whether used inon its own or combination with a sedative or . Furthermore, it provides minimal cardiac risks, early case ambulation, satisfactory postoperative pain control, as well as a reduced hospital stay and cost. one of the major drawbacks of spermatic cord block is being a single injection technique, leading to a short postoperative analgesia duration. So, to overcome this flaw some adjuvants were proven to prolong the analgesia duration as neostigmine.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

112Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control group	Active Comparator		Drug: Control Test
neostigmine group	Active Comparator		Drug: Neostigmine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Control Test	Drug	spermatic cord block by 19 ml Levobupivacaine 0.5% plus 1 ml 0.9 normal saline in each side	control group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time from end of surgery to the first postoperative analgesic request	(duration of the block).	UP TO 24 HOURE

Secondary Outcomes

Measure	Description	Time Frame
visual analog scale	visual analog scale ; 0 is bad / 10: is good	UP TO 24 HOURE
spermatic cord block time	The mean time needed to perform spermatic cord block

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged from 20 to 45 years.
American Society of Anesthesiologists I-II.
Undergoing Testicular Sperm Extraction Surgery.
BMI from 18.5 to 40 kg/m2

Exclusion Criteria:

Patient refusal
Contraindications to regional anesthesia (bleeding disorders e.g. international normalized ratio >1.5, Prothrombin Concentration <70%, platelet count<100 × 109, use of any anti-coagulants, local infection, etc.).
Known allergy to local anesthetics.
ASA III-IV.
Patients aged less than 18 or more than 60.
Body mass index >35.:

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

operation in male only

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amr wahdan	lecture	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Cairo University.		Cairo		11451	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

sill working

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009388	Neostigmine

Ancestor Terms

ID	Term
D050338	Phenylammonium Compounds
D000644	Quaternary Ammonium Compounds
D000588	Amines
D009930	Organic Chemicals

Browse Leaves

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Browse Branches

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