Addition of Neostigmine to Levobupivacaine

Sponsor

Cairo University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04492319

Collaborator

(none)

112

Enrollment

Location

Arms

15.7

Anticipated Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spermatic Cord Block	Drug: Control Test Drug: Neostigmine	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

112 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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:

Actual Study Start Date :

Jun 29, 2020

Anticipated Primary Completion Date :

Jul 23, 2021

Anticipated Study Completion Date :

Oct 20, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: control group

Drug: Control Test

spermatic cord block by 9.5 ml Levobupivacaine 0.5% plus 0.5 ml 0.9 normal saline in each side

Active Comparator: neostigmine group

Drug: Neostigmine

spermatic cord block by 9,5 ml Levobupivacaine 0.5% plus neostigmine 250 μg in each side .

Outcome Measures

Primary Outcome Measures

Time from injection of Local anaesthesia to the first postoperative analgesic request [UP TO 24 HOURE]
(duration of the block).

Secondary Outcome Measures

visual analog scale [UP TO 24 HOURE]
visual analog scale ; 0 is bad / 10: is good
spermatic cord block time [UP TO 1 HOURE]
The mean time needed to perform spermatic cord block
Incidence of complications [up to 24 hours]
complications
mean arterial blood pressure [UP TO 24 HOURE]
mean arterial blood pressure
heart rate [up to 24 hours]
heart rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Cairo University.	Cairo		Egypt	11451

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Amr wahdan, lecture

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amr Samir Wahdan, Lecturer of Anesthesia, Pain management and Surgical ICU, Cairo University

ClinicalTrials.gov Identifier:

NCT04492319

Other Study ID Numbers:

N-18-2020

First Posted:

Jul 30, 2020

Last Update Posted:

Dec 28, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Amr Samir Wahdan, Lecturer of Anesthesia, Pain management and Surgical ICU, Cairo University

Spermatic Cord Block

Neostigmine

Levobupivacaine

Additional relevant MeSH terms:

Neostigmine

Study Results

No Results Posted as of Dec 28, 2020