The Effect of Ultrasound-guided Erector Spinae Block on Postoperative in Patients Undergoing Nephrectomy.

Nephrectomy Clinical Trial

Official title:

The Effect of Ultrasound-guided Erector Spinae Block on Postoperative Analgesic Consumption in Patients Undergoing Nephrectomy. Prospective Randomized Single-center Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04703634
• Other study ID #: Interventional
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Nephrectomy

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