Effectivenes of Erector Spinae Plane Block in Percutaneous Nephrolithotomy?

NCT ID: NCT04474873

Last Updated: 2020-07-17

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

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2020-08-30

Brief Summary

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This study investigates the effectiveness of the erector spinae plane block (ESPB) in pain management of patients undergoing PNL.

Detailed Description

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Although percutaneous nephrolithotomy(PNL) is a minimally invasive procedure, it causes severe postoperative pain due to dilatation of the renal capsule and parenchymal duct and peritubal distension of the nephrostomy tube. PNL-related pain has a limited response to oral and intravenous treatments. The primary aim of our study is to investigate the effectiveness of the erector spinae plane block (ESPB) in pain management of patients undergoing PNL.

Our secondary aim is determining if any possible clinical effect of ESPB in terms of serial peak expiratory flow measurements, postoperative agitation score of the patient (Riker Score), ambulation time, length of hospital stay.

Conditions

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Postoperative Pain Nephrolithotomy, Percutaneous Erector Spinae Plane Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group 1:Conventional intravenous analgesia

Conventional intravenous analgesia applied according to surgeon's preference

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 2:ESPB

A 6-13 MHz linear probe was used for ultrasound-guided ESPB (Logiq e, General Electric, USA,) performed at the T11 level. The transverse process was detected by sliding the transducer 3-4 cm laterally from the midline, and after identification of the transverse process, a 20-gauge 100mm insulated echogenic needle (Vygon locoplex, France) was used

Group Type ACTIVE_COMPARATOR

erector spinae block

Intervention Type PROCEDURE

we administer 15 cc of 0.5% bupivacaine between the erector spine muscle and the transverse process. The distribution of bupivacain was observed on ultrasound.

Interventions

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erector spinae block

we administer 15 cc of 0.5% bupivacaine between the erector spine muscle and the transverse process. The distribution of bupivacain was observed on ultrasound.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients undergoing PNL between 18-65 years old

Exclusion Criteria

* serious cardiac, respiratory, hepatic, renal or haemotologic disease
* mental disorder and hearing problem
* anxiety, depression and / or other psychiatric disorders
* pregnancy
* refusal of patient
* Allergy or contraindications to drugs used in the study
* ASA \> 2 Inflammation or infection over injection site Obese patients BMI ≥35/
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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semih başkan

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Semih Baskan, 2

Role: STUDY_DIRECTOR

Ankara City Hospital Anesthesiology Department

Locations

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Ankara City Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Ibrahim M, Elnabtity AM. Analgesic efficacy of erector spinae plane block in percutaneous nephrolithotomy : A randomized controlled trial. Anaesthesist. 2019 Nov;68(11):755-761. doi: 10.1007/s00101-019-00673-w. Epub 2019 Oct 16.

Reference Type BACKGROUND
PMID: 31620856 (View on PubMed)

Other Identifiers

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E1-20-315

Identifier Type: -

Identifier Source: org_study_id

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