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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06078241
Other study ID # FMASU MS 556/ 2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date April 30, 2024

Study information

Verified date November 2023
Source Ain Shams University
Contact Ibrahim Mamdouh Esmat
Phone 01001241928
Email ibrahim_mamdouh@med.asu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Percutaneous nephrolithotomy (PCNL) is a minimally invasive procedure to remove stones from the kidney by a small puncture wound through the skin. Patients receiving lidocaine infusion had lower pain scores, reduced postoperative analgesic requirements and decreased intraoperative anesthetic requirements. Erector spinae plane block (ESPB) seems to be effective when compared with no block or a placebo block.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date April 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 21 Years to 55 Years
Eligibility Inclusion Criteria: - American Society of Anesthesiologists (ASA) score I-II.. - Body mass index < 35 kg/m2. Exclusion Criteria: - Patient's refusal. - Known coagulopathy. - Known peripheral neuropathy or neurological deficits. - Chronic pain disorders. - Known allergy to study drugs

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Intravenous lidocaine infusion
Intravenous lidocaine infusion
Other:
Erector spinae plane block (ESPB)
Unilateral erector spinae plane block
Intravenous infusion of normal saline
Intravenous infusion of normal saline
ESPB with normal saline
Unilateral ESPB with normal saline

Locations

Country Name City State
Egypt Ain-Shams University Hospitals Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to first rescue analgesia Time to first rescue analgesia 24 hours postoperatively
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