Clinical trial

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:

Name
N-18-2020
Description
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 arms
Trial start
2020-09-29
Estimated PCD
2023-11-23
Trial end
2023-12-20
Status
Completed
Treatment
Control Test
spermatic cord block by 19 ml Levobupivacaine 0.5% plus 1 ml 0.9 normal saline in each side
Arms:
control group
Neostigmine
spermatic cord block by 19 ml Levobupivacaine 0.5% plus 1 ml neostigmine 500 μg in each side .
Arms:
neostigmine group
Size
112
Primary endpoint
Time from end of surgery to the first postoperative analgesic request
UP TO 24 HOURE
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.:
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 112, 'type': 'ACTUAL'}}
Updated at
2024-01-09

1 organization

2 products

1 indication

Organization
Cairo University