Analgesic Efficacy of Ultrasound Guided Paravertebral Block in Percutaneous Nephrolithotomy Patients

NCT ID: NCT04406012

Last Updated: 2020-09-29

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

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-16

Study Completion Date

2016-07-01

Brief Summary

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The aim of this study is to investigate the analgesic effects of thoracal paravertebral block in the patients undergoing percutaneous nephrolitotomy. Paravertebral block was applied to the study group. Conventional analgesia methods were applied to the control group.

Detailed Description

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Randomization was divided into two groups by using closed envelope method. Postoperative pain scores at rest at 1, 2, 4, 6, 8, 10, 12, and 24 hours with VAS (0 = no pain, very severe pain = 10) using Visual Analogue Scale was made. VAS at rest and movement (coughing and taking a deep Breath) were evaluated. Patients with VAS\> 4 received additional analgesics.

Conditions

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Pain, Postoperative; Anesthesia, Regional

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Paravertebral block group and Control group
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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block group

Paravertebral group at Thoracic 9-10 vertebrae level with an in-plane technique advanced ultrasound guided 10 ml bupivacaine hydrochloride (Marcaine 0.5%, Astra Zeneca) in 20 ml volume was enjected in the paravertebral area with real-time visualisation It was observed that the local anesthetic drug spread on the pleura and the pleura was pushed. All blocks were performed by the same experienced anaesthesiologist.

Group Type ACTIVE_COMPARATOR

paravertebral block

Intervention Type PROCEDURE

paravertebral block group

Control group

Conventional analgesia methods were applied to the control group. Control group was relieved by dexketoprofen 50mg intravenously. If the patient was not relieved with dexketoprofen and VAS score \>4, tramadol 1 mg kg-1 was administered intravenously.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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paravertebral block

paravertebral block group

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

ASA I, II, III patients aged 18-65 who consented to undergo unilateral percutaneous nephrolithotomy were eligible for the study. 53 patients were eligible and assesed.Informed consent was signed by all patients.

Exclusion Criteria

Patients under 18 years of age, pregnant, with known hypersensitivity to local anesthetics, bleeding diathesis, depression and / or anxiety disorder, obesity (BMI\> 35kg / m2), history of pneumothorax, phrenic nerve paralysis, severe aortic stenosis were excluded. Also who did not want to participate the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kırıkkale University

OTHER

Sponsor Role collaborator

Eskisehir Osmangazi University

OTHER

Sponsor Role lead

Responsible Party

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Ferda YAMAN

Assist. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Yaman F, Tuglu D. Analgesic efficacy of ultrasound guided paravertebral block in percutaneous nephrolithotomy patients: a randomized controlled clinical study. BMC Anesthesiol. 2020 Sep 29;20(1):250. doi: 10.1186/s12871-020-01169-6.

Reference Type DERIVED
PMID: 32993528 (View on PubMed)

Other Identifiers

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Kırıkkale University

Identifier Type: OTHER

Identifier Source: secondary_id

Eskisehir University

Identifier Type: -

Identifier Source: org_study_id

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