Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy

Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy: A Prospective, Randomized, Controlled, Single Blind Study

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Erector Spinae Plane Block; Anesthesia and Analgesia; Nerve Block; Anesthetics, Local; Nephrolithotomy, Percutaneous
• Intervention / Treatment: Procedure: Ultrasound Guided Erector Spinae Plane Block Catheterisation; Drug: Bupivacaine 0.25% Injectable Solution

Detailed Description

Erector Spinae Plane Block(ESP) is a rather new method which can block ventral and dorsal rami of spinal nerves in the paravertebral area after they leave the spinal column. Originally used for thoracic somites, by spreading in a craniocaudal fashion in the erector spinae muscle group, it has the potential of blocking cervical or lumbar nerves as well.

To provide better analgesia for surgical procedures, anesthesiologists use truncal blocks for peripheral intervention. Although these blocks are generally very effective and easy to apply, they are limited by a relatively small area of effectivity. In order to achieve denser effects for larger surfaces, epidural anesthesia must be used with the risk of more severe complications than any peripheral or truncal nerve blocks. Epidural anesthesia also has the disadvantages of requiring more experience and more cautiousness than ultrasound-guided truncal blocks and risks of an undesirable temporary motor blockade. ESP block could be the answer for better regional analgesia while avoiding motor blockade and complications of epidural anesthesia.

The study will have two groups as Block Group(GB) and Control Group(GC) and two periods as during operation and 48 hours after the operation. Every participant will receive Total Intravenous Anesthesia(TIVA) and will be monitored with ECG, non-invasive blood pressure, heart rate, pulse oximeter, and Bispectral Index. Participants in GB will receive ultrasound-guided ESP block catheter after proper maintenance of anesthesia provided. The first period will be during operation. We will evaluate the administered drug amounts per kilogram for each patient. Investigators believe ESP block will help them deliver proper anesthesia with lower dosages. The second period will include postoperative 48 hours. Pain scores(NRS) will be evaluated at certain time intervals and at two critical moments between the two groups. One of the critical moment which patients fear and feel the pain most is the removal time of nephrostomy. The second moment is the first time patients start walking.

Rescue analgesia will be ordered on demand for both groups as IV 1 mg/kg tramadol. Hours and amounts of rescue analgesia administered will be recorded.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • İzmir
    • Karabaglar, İzmir, Turkey, 35170
      • Izmir Bozyaka Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: GCont; Only dressing will be applied to patients without actually nerve catheter performed
EXPERIMENTAL: GBlock; 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; 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; Other Names: Marcain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Consumption	Opioids(Tramadol) will be administered to patients in case demanded.	48 hour post-operatively
Discharge	Day of the discharge	240 hours post-operatively

Collaborators and Investigators

• Sponsor: Bozyaka Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 5, 2018
• Primary Completion (ACTUAL): March 10, 2019
• Study Completion (ACTUAL): March 15, 2019

Study Registration Dates

• First Submitted: August 28, 2018
• First Submitted That Met QC Criteria: August 28, 2018
• First Posted (ACTUAL): August 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 23, 2021
• Last Update Submitted That Met QC Criteria: April 21, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Truncal Nerve Blocks, Ultrasound Guided Nerve Blocks
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: ESPforPNL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No