Addition of Neostigmine to Levobupivacaine

NCT ID: NCT04492319

Last Updated: 2024-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-29
• Study Completion Date: 2023-12-20

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.

Conditions

Spermatic Cord Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

control group

Group Type: ACTIVE_COMPARATOR

Control Test

Intervention Type: DRUG

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

neostigmine group

Group Type: ACTIVE_COMPARATOR

Neostigmine

Intervention Type: DRUG

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

Interventions

Control Test

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

Intervention Type: DRUG

Neostigmine

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

Intervention Type: DRUG

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.:

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Amr Samir Wahdan

Lecturer of Anesthesia, Pain management and Surgical ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amr wahdan

Role: PRINCIPAL_INVESTIGATOR

lecture

Locations

Faculty of Medicine, Cairo University.

Cairo, , Egypt

Countries

Egypt

Other Identifiers

N-18-2020

Identifier Type: -

Identifier Source: org_study_id