NCT04492319

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration 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

First Submitted

Initial submission to the registry

June 3, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 30, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 29, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2023

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

3.2 years

First QC Date

June 3, 2020

Last Update Submit

January 5, 2024

Conditions

Spermatic Cord Block

Keywords

Spermatic Cord BlockNeostigmineLevobupivacaine

Outcome Measures

Primary Outcomes (1)

  • Time from end of surgery to the first postoperative analgesic request

    (duration of the block).

    UP TO 24 HOURE

Secondary Outcomes (4)

  • visual analog scale

    UP TO 24 HOURE

  • spermatic cord block time

    UP TO 1 HOURE

  • Incidence of complications

    up to 24 hours

  • Postoperative analgesic use

    up to 24 hours

Study Arms (2)

control group

ACTIVE COMPARATOR
Drug: Control Test

neostigmine group

ACTIVE COMPARATOR
Drug: Neostigmine

Interventions

Control TestDRUG

spermatic cord block by 19 ml Levobupivacaine 0.5% plus 1 ml 0.9 normal saline in each side

control group
NeostigmineDRUG

spermatic cord block by 19 ml Levobupivacaine 0.5% plus 1 ml neostigmine 500 μg in each side .

neostigmine group

Eligibility Criteria

Age20 Years - 60 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsoperation in male only
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Cairo University.

Cairo, 11451, Egypt

Location

MeSH Terms

Interventions

Neostigmine

Intervention Hierarchy (Ancestors)

Phenylammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium Compounds

Study Officials

  • Amr wahdan

    lecture

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesia, Pain management and Surgical ICU

Study Record Dates

First Submitted

June 3, 2020

First Posted

July 30, 2020

Study Start

September 29, 2020

Primary Completion

November 23, 2023

Study Completion

December 20, 2023

Last Updated

January 9, 2024

Record last verified: 2024-01

Locations

EG(1)