Addition of Neostigmine to Levobupivacaine

Spermatic Cord Block Clinical Trial

Official title:

The Effect of Addition of Neostigmine to Levobupivacaine in Male Patients Receiving Ultrasound Guided Spermatic Cord Block for Postoperative Analgesia in Testicular Sperm Extraction Surgery:

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04492319
• Other study ID #: N-18-2020
• Status: Completed
• Phase: N/A
• Start date: September 29, 2020
• Est. completion date: December 20, 2023

Study information

• Verified date: January 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 20, 2023
• Est. primary completion date: November 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 60 Years

Eligibility

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.:

Related Conditions & MeSH terms

• Spermatic Cord Block

Intervention

Drug:
• Control Test
spermatic cord block by 19 ml Levobupivacaine 0.5% plus 1 ml 0.9 normal saline in each side
• Neostigmine
spermatic cord block by 19 ml Levobupivacaine 0.5% plus 1 ml neostigmine 500 µg in each side .

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Cairo University.	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from end of surgery to the first postoperative analgesic request	(duration of the block).	UP TO 24 HOURE
Secondary	visual analog scale	visual analog scale ; 0 is bad / 10: is good	UP TO 24 HOURE
Secondary	spermatic cord block time	The mean time needed to perform spermatic cord block	UP TO 1 HOURE
Secondary	Incidence of complications	complications	up to 24 hours
Secondary	Postoperative analgesic use	amount of Acetaminophen used postoperative	up to 24 hours