Analgesic Efficacy of Ultrasound Guided Paravertebral Block in Percutaneous Nephrolithotomy Patients

Sponsor

Eskisehir Osmangazi University (Other)

Overall Status

Completed

CT.gov ID

NCT04406012

Collaborator

Kırıkkale University (Other)

Enrollment

Arms

4.5

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative; Anesthesia, Regional	Procedure: paravertebral block	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

53 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Paravertebral block group and Control groupParavertebral block group and Control group

Masking:

Single (Investigator)

Primary Purpose:

Supportive Care

Official Title:

Analgesic Efficacy of Ultrasound Guided Paravertebral Block in Percutaneous Nephrolithotomy Patients: A Randomized Controlled Clinical Study

Actual Study Start Date :

Feb 16, 2016

Actual Primary Completion Date :

Jun 16, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Procedure: paravertebral block paravertebral block group
No Intervention: 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.

Arm

Intervention/Treatment

Active Comparator: 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.

Procedure: paravertebral block

paravertebral block group

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

Patient VAS scores [24 hours]
0=no pain, 10=incredible pain

Secondary Outcome Measures

Patient Satisfaction scores [at the end of the 24 hours]
0=not satisfied, 5=very good satisfied

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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. 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Eskisehir Osmangazi University
Kırıkkale University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ferda YAMAN, Assist. Prof. Dr., Eskisehir Osmangazi University

ClinicalTrials.gov Identifier:

NCT04406012

Other Study ID Numbers:

Eskisehir University
Kırıkkale University

First Posted:

May 28, 2020

Last Update Posted:

Sep 29, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ferda YAMAN, Assist. Prof. Dr., Eskisehir Osmangazi University

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Sep 29, 2020