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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03652103
Other study ID # ESPforPNL
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 5, 2018
Est. completion date March 15, 2019

Study information

Verified date April 2021
Source Bozyaka Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Investigators' goal is to determine whether Erector Spinae Plane Block would provide a better analgesia, help mobilization and early discharge or increase satisfaction for patients undergoing Percutaneous Nephrolithotomy(PNL). One of the two groups will receive ESP catheterization after general anesthesia conducted. The other group will receive routine analgesia protocol used for PNL. The total amount of drugs administered, pain scores(NRS) at certain time intervals and at certain events(removal of nephrostomy and pain at mobilization) will be recorded and compared.


Description:

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Study Design


Intervention

Procedure:
Ultrasound Guided Erector Spinae Plane Block Catheterisation
After receiving general anesthesia, patients will positioned prone. Before operation begins, ESP block catheter will be applied with ultrasound guidance to the same level as surgeon's incision.
Drug:
Bupivacaine 0.25% Injectable Solution
Perineural Injection

Locations

Country Name City State
Turkey Izmir Bozyaka Training and Research Hospital Karabaglar Izmir

Sponsors (1)

Lead Sponsor Collaborator
Bozyaka Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dosage of Drugs Amounts of drugs per kilogram per hour will be recorded During procedure
Primary Post-operative pain assessed by Numeric Rating Scale (NRS) Pain scores will be recorded as reported by the patient according to NRS 30th minute postoperatively
Primary Post-operative pain assessed by Numeric Rating Scale (NRS) Pain scores will be recorded as reported by the patient according to NRS 60th minute postoperatively
Primary Post-operative pain assessed by Numeric Rating Scale (NRS) Pain scores will be recorded as reported by the patient according to NRS 2nd hour postoperatively
Primary Post-operative pain assessed by Numeric Rating Scale (NRS) Pain scores will be recorded as reported by the patient according to NRS 6th hour postoperatively
Primary Post-operative pain assessed by Numeric Rating Scale (NRS) Pain scores will be recorded as reported by the patient according to NRS 12th hour postoperatively
Primary Post-operative pain assessed by Numeric Rating Scale (NRS) Pain scores will be recorded as reported by the patient according to NRS 24th hour postoperatively
Primary Post-operative pain assessed by Numeric Rating Scale (NRS) Pain scores will be recorded as reported by the patient according to NRS 48th hour postoperatively
Primary Post-operative pain assessed by Numeric Rating Scale (NRS) Pain scores will be recorded during the first steps as reported by the patient according to NRS Mobilisation at postoperative day (POD) 1
Primary Post-operative pain assessed by Numeric Rating Scale (NRS) Pain scores will be recorded during the procedure as reported by the patient according to NRS At the time of removal of nephrostomy at postoperative day (POD) 2
Secondary Opioid Consumption Opioids(Tramadol) will be administered to patients in case demanded. 48 hour post-operatively
Secondary Discharge Day of the discharge 240 hours post-operatively
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