Erector Spinae Plane Block and Spinal Anesthesia for Supine Percutaneous Nephrolithotomy

NCT04947072 | Unknown DMC

• 1 other identifier: IndonesiaUAnes106
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to compare the Effectiveness of Erector Spinae plane block to Spinal as a surgical anesthesia and analgesia in Percutaneous Nephrolithotomy patient

Conditions

Incidence Conversion to General Anesthesia, Interleukin-6, Total Tramadol Consumption and Pain Score After Surgery

Keywords

Erector Spinae Plane Block; Percutaneous Nephrolithotomy; Interleukin-6, Effectiveness; Tramadol patient controlled analgesia; Visual analog scale

Outcome Measures

Primary Outcomes (1)

• Incidence conversion to general anesthesia

  This outcome will be measured based on the concentration of propofol needed throughout the surgery. If the concentration of propofol exceeds 3.5 mcg/ml, anesthesia will be converted to a general anesthesia.

  intraoperatively

Secondary Outcomes (1)

• Interleukin -6 plasma concentration

  24 hours after surgery

Study Arms (2)

Erector Spinae Plane Block

EXPERIMENTAL

Patient will receive single-shot ultrasound-guided erector spinae plane block at the level of T9 on the side which will be operated on.

Procedure: Erector Spinae Plane Block; Procedure: Spinal anesthesia

Spinal Anesthesia

ACTIVE COMPARATOR

Patient will receive spinal anesthesia at the level of L3-L4 or L4-L5

Procedure: Erector Spinae Plane Block; Procedure: Spinal anesthesia

Interventions

Erector Spinae Plane Block PROCEDURE

The block will be performed at the level of T9 on the site that will be operated and patient will be given Bupivacaine isobaric 0.5% 25 ml with epinephrine 1:200.000

Erector Spinae Plane Block; Spinal Anesthesia

Spinal anesthesia PROCEDURE

Patient will be given bupivacaine hyperbaric 0.5% 16-18 mg at the level of L3-L4 or L4-L5

Erector Spinae Plane Block; Spinal Anesthesia

Eligibility Criteria

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

You may qualify if:

• Age 18 years old and above
• ASA 1,2 and 3
• Patient who will undergo elective supine Percutaneous Nephrolithotomy

You may not qualify if:

• Patient who does not agree to be included in the study
• BMI \<18.5 kg/m2 or \> 40 kg/m2
• Patient with single functional kidney
• Patient who is contraindicated for local anesthetics
• Patient who has severe heart disorder
• Patient with communication disability and cognitive disorders
• Patient with chronic pain with history of high opioid consumption and or alcohol addiction
• Pregnant patient

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

RECRUITING

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Pry P Pryambodho, Doctor

  Indonesia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pry P Pryambodho, doctor

CONTACT

0213143336; bungsu.ragil@gmail.com

Aida Rosita R Tantri

CONTACT

0213143336; aidatantri@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 26, 2021
• First Posted: July 1, 2021
• Study Start: September 14, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 29, 2021

Record last verified: 2021-12

Locations

ID (1)