Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy

NCT03652103 | Completed Phase 4 DMC

• 1 other identifier: ESPforPNL
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nephrolithotomy, Percutaneous; Anesthetics, Local; Nerve Block; Erector Spinae Plane Block; Pain, Postoperative; Anesthesia and Analgesia

Keywords

Truncal Nerve Blocks, Ultrasound Guided Nerve Blocks

Outcome Measures

Primary Outcomes (10)

• Dosage of Drugs

  Amounts of drugs per kilogram per hour will be recorded

  During procedure

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Opioid Consumption

  48 hour post-operatively

• Discharge

  240 hours post-operatively

Study Arms (2)

GCont

NO INTERVENTION

Only dressing will be applied to patients without actually nerve catheter performed

GBlock

EXPERIMENTAL

Ultrasound Guided Erector Spinae Plane Block Catheter will be applied: 20ml Bupivacaine 0.25% Injectable Solution\* will be administered initially. 20 ml Bupivacaine %0.25 Injectable Solution\*\* will be administered 30 minutes before ambulation at postoperative day(POD) 0 and before removal of nephrostomy at POD 2 \*10ml %0,5 Bupivacaine will be diluted with 10ml Saline solution.

Procedure: Ultrasound Guided Erector Spinae Plane Block Catheterisation; Drug: Bupivacaine 0.25% Injectable Solution

Interventions

Ultrasound Guided Erector Spinae Plane Block Catheterisation PROCEDURE

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.

GBlock

Bupivacaine 0.25% Injectable Solution DRUG

Perineural Injection

Also known as: Marcain

GBlock

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are scheduled for percutaneous nephrolithotomy under total intravenous anesthesia
• Patients who has informed consent for study
• Patients with American Society of Anesthesiologists Physical Status Classification(ASA) I and II

You may not qualify if:

• Patient's refusal to participate
• Patients under 18 years of age
• Patients who are undergoing surgery with an anesthesia technique other than total intravenous anesthesia for any reason (inhalation anesthesia, laryngeal mask application, etc.)
• Patients with known local anesthetic allergy
• Patients with Body mass index \> 35
• Patients diagnosed sepsis and bacteriemia,
• Skin infection at the injection site,
• Patients with previous spinal surgery
• History of coagulopathy or anticoagulant therapy
• Patients with uncontrolled diabetes ,
• Uncoordinated patients,
• Psychological and emotional lability,
• Surgical intervention longer than 3 hours.

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

Izmir Bozyaka Training and Research Hospital

Karabağlar, İzmir, 35170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Resident

Model Details: Two groups involved. First group will receive total intravenous anesthesia and erector spinae plane block catheter Second group will receive total intravenous anesthesia and routine analgesia protocol for percutaneous Nephrolithotomy procedures.

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: August 29, 2018
• Study Start: September 5, 2018
• Primary Completion: March 10, 2019
• Study Completion: March 15, 2019
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)