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Erector Spinae Plane Block and Spinal Anesthesia for Supine Percutaneous Nephrolithotomy

NCT ID: NCT04947072

Last Updated: 2021-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-14

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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Thirty subjects (who meet all inclusion criteria and do not have exclusion criteria) are given informed consent before enrolling the study and randomized into two groups: erector spinae plane block and spinal. Non-invasive blood pressure monitor, electrocardiogram (ECG), and pulse-oxymetry will be set on the subjects in the operation room. Peripheral venous blood samples will be taken for IL-6 examination. All patients will be sedated using Target Controlled Infusion with propofol (Schnider model, effect site) to obtain mild-moderate sedation prior to the block. On Erector Spinae Plane group, single-shot ultrasound guided block will be performed on the operated side with stimuplex 100 mm needle and 25 ml of isobaric bupivacaine 0.5% with epinephrine 1:200.000 will be administered at level Th 9. On the Spinal group, spinal anesthesia will be performed on lateral decubitus position at the level of L3-L4 or L4-L5 and hyperbaric bupivacaine 0.5% 16-18 mg will be given as regimen. Prior to urethral manipulation, all subjects will be given fentanyl iv 50 mcg and sedation with TCI Propofol will be maintained throughout the procedure. Sensory loss was evaluated by performing skin clamping with a scalpel at the level of the incision before the surgery. The ESP block was considered successful in providing surgical anaesthesia when there was no movement and significant changes in vital signs during skin clamping and throughout the surgery.

Conditions

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

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Erector Spinae Plane Block

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

Group Type EXPERIMENTAL

Erector Spinae Plane Block

Intervention Type 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

Spinal anesthesia

Intervention Type PROCEDURE

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

Spinal Anesthesia

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

Group Type ACTIVE_COMPARATOR

Erector Spinae Plane Block

Intervention Type 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

Spinal anesthesia

Intervention Type PROCEDURE

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

Interventions

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Erector Spinae Plane Block

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

Intervention Type PROCEDURE

Spinal anesthesia

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Pryambodho Pryambodho

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pry P Pryambodho, Doctor

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Locations

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Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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Pry P Pryambodho, doctor

Role: CONTACT

Phone: 0213143336

Email: [email protected]

Aida Rosita R Tantri

Role: CONTACT

Phone: 0213143336

Email: [email protected]

Facility Contacts

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Pryambodho Pryambodho

Role: primary

Other Identifiers

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IndonesiaUAnes106

Identifier Type: -

Identifier Source: org_study_id