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Completed

NCT Number: NCT04492319

Addition of Neostigmine to Levobupivacaine

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.

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Key information

Conditions

Spermatic Cord Block

Age range

20 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Cairo University.

Cairo, 11451, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.:

Treatment and study plan

Control Test

Drug

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

Neostigmine

Drug

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

Primary outcomes

  1. Time from end of surgery to the first postoperative analgesic request

    Time frame: UP TO 24 HOURE

    (duration of the block).

Secondary outcomes

  1. visual analog scale

    Time frame: UP TO 24 HOURE

    visual analog scale ; 0 is bad / 10: is good

  2. spermatic cord block time

    Time frame: UP TO 1 HOURE

    The mean time needed to perform spermatic cord block

  3. Incidence of complications

    Time frame: up to 24 hours

    complications

  4. Postoperative analgesic use

    Time frame: up to 24 hours

    amount of Acetaminophen used postoperative

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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:

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 30, 2020
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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