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Erector Spinae Plane Block and Spinal Anesthesia for Supine Percutaneous Nephrolithotomy

Sponsor
Indonesia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04947072
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
15.5
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Erector Spinae Plane Block
  • Procedure: Spinal anesthesia
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison Between Erector Spinae Plane Block and Spinal as Surgical Anesthesia and Analgesia in Percutaneous Nephrolithotomy Patient : Conversion to General Anesthesia, Interleukin-6, Postoperative Pain and Opioid Consumption
Actual Study Start Date :
Sep 14, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Procedure: 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

Procedure: Spinal anesthesia
Patient will be given bupivacaine hyperbaric 0.5% 16-18 mg at the level of L3-L4 or L4-L5
Active Comparator: Spinal Anesthesia

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

Procedure: 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

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

Outcome Measures

Primary Outcome Measures

  1. Incidence conversion to general anesthesia [intraoperatively]

    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.

Secondary Outcome Measures

  1. Interleukin -6 plasma concentration [24 hours after surgery]

    Interleukin 6 will be measured 3 times, before surgery, 6 hours after surgery and 24 hours after surgery.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cipto Mangunkusumo Hospital Jakarta Pusat DKI Jakarta Indonesia 10430

Sponsors and Collaborators

  • Indonesia University

Investigators

  • Principal Investigator: Pry P Pryambodho, Doctor, Indonesia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pryambodho Pryambodho, Doctor, Indonesia University
ClinicalTrials.gov Identifier:
NCT04947072
Other Study ID Numbers:
  • IndonesiaUAnes106
First Posted:
Jul 1, 2021
Last Update Posted:
Dec 29, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pryambodho Pryambodho, Doctor, Indonesia University
Erector Spinae Plane Block
Percutaneous Nephrolithotomy
Interleukin-6, Effectiveness
Tramadol patient controlled analgesia
Visual analog scale
Additional relevant MeSH terms:
Anesthetics

Study Results

No Results Posted as of Dec 29, 2021