Addition of Neostigmine to Levobupivacaine

Study Overview
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Brief Summary
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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.

Official Title
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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:

Conditions
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Spermatic Cord Block

Intervention / Treatment
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* Drug: Control Test
* Drug: Neostigmine


Participation Criteria
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Eligibility Criteria
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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.:

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group<br> | Drug: Control Test<br>* spermatic cord block by 9.5 ml Levobupivacaine 0.5% plus 0.5 ml 0.9 normal saline in each side<br>|
| Active Comparator: neostigmine group<br> | Drug: Neostigmine<br>* spermatic cord block by 9,5 ml Levobupivacaine 0.5% plus neostigmine 250 μg in each side .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from injection of Local anaesthesia to the first postoperative analgesic request | (duration of the block). | UP TO 24 HOURE | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analog scale | visual analog scale ; 0 is bad / 10: is good | UP TO 24 HOURE | 
| spermatic cord block time | The mean time needed to perform spermatic cord block | UP TO 1 HOURE | 
| Incidence of complications | complications | up to 24 hours | 
| mean arterial blood pressure | mean arterial blood pressure | UP TO 24 HOURE | 
| heart rate | heart rate | up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spermatic Cord Block, Neostigmine, Levobupivacaine