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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04703634
Other study ID # Interventional
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 14, 2021
Est. completion date May 17, 2021

Study information

Verified date August 2021
Source Namik Kemal University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate the postoperative effect of erector spinae block in patients undergoing nephrectomy that causes both visceral and somatic pain.


Description:

After being informed and potential risks about the study, all patients have given written consent will undergo 24 hours screening for the analgesic effect of erector spinae block after nephrectomy. Patients meeting the criteria were randomly selected in double-blind manner 1:1 ratio to erector spiane block or not.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date May 17, 2021
Est. primary completion date May 17, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. To undergo partial or total nephrectomy surgery 2. To be in ASA I-II classification 3. To be between the ages of 18-65. 4. Not having problems that prevent erector spinae block application such as local anesthetic drug allergy, infection at the injection site, and structural anomaly. 5. Being in good mental and psychological health 6. To accept to participate in the study. Exclusion Criteria: 1. Being in ASA III or IV class with a high risk of anesthesia 2. Being outside the age range of 18-65 3. Having problems such as local anesthetic drug allergy, infection at the injection site, and structural anomaly prevents block application. 4. Not being mentally and psychologically healthy 5. Those who are allergic to the active substance, patients using antiepileptic drugs 6. Those with severe hepatic and renal failure 7. Those who have long-term use of nonsteroidal anti-inflammatory and opioid analgesic, 8. Those with diabetes and other neuropathic diseases 9. Patients who cannot use patient-controlled analgesia (PCA) device

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
erector spinae block (ESP)
Administration of local anesthetic under the erector spinae muscle just below the transverse process of the thoracic 12th vertebra

Locations

Country Name City State
Turkey Namik Kemal University Tekirdag Süleymanpasa

Sponsors (1)

Lead Sponsor Collaborator
Namik Kemal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Numerical Rating Scale (NRS) Numerical Rating Scale (NRS) will be used for postoperative evaluation. NRS is a segmented digital version of the visual analog scale. Selecting an integer (0-10 integers) by a responder in (VAS). It is accepted as one dimensional-the measure of pain intensity in adults. The 11-point numerical scale ranges from "0" to "10," representing a pain ("no pain"). 10 ("as bad pain as you can imagine"), or ("the worst pain imaginable"). 24 hours
Secondary Recovery analgesia Secondary outcome measures will be routine (paracetamol or tramadol PCA) or recovery. Analgesic use will be recorded within the first 24 hours. 24 hours
Secondary postoperative nausea and vomiting The severity of nausea and vomiting 4-point scale (none, mild, moderate, and severe). As will be recorded by the nurses in the ward. 24 hours
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