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

NCT ID: NCT04703634

Last Updated: 2021-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-14
• Study Completion Date: 2021-05-17

Brief 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.

Detailed 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.

Conditions

Nephrectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

erector spinae group

All blocks will be done under general anesthesia. Using a 6-10 MHz linear ultrasound (Esaote my-lab 6, Italy). With the ultrasonography device of our clinic, the side of the nephrectomy surgery will be performed with the position of the nephrectomy, and the position (lateral decubitus) is given to the patient. The thoracic 10th vertebra will be found under ultrasound guidance. After the T12 transverse protrusion is seen by sliding 3 cm laterally from the midline, 30 ml of 0.25% Bupivacaine will be injected under the erector spinae muscle above it.

Group Type: EXPERIMENTAL

erector spinae block (ESP)

Intervention Type: PROCEDURE

Administration of local anesthetic under the erector spinae muscle just below the transverse process of the thoracic 12th vertebra

placebo group

No block transaction will be applied to this group. Only postoperative analgesia methods will be used for this group as specified in the protocol.

Group Type: PLACEBO_COMPARATOR

erector spinae block (ESP)

Intervention Type: PROCEDURE

Administration of local anesthetic under the erector spinae muscle just below the transverse process of the thoracic 12th vertebra

Interventions

erector spinae block (ESP)

Administration of local anesthetic under the erector spinae muscle just below the transverse process of the thoracic 12th vertebra

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Namik Kemal University

OTHER

Sponsor Role: lead

Responsible Party

Ayhan ŞAHİN

Asistant Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayhan ŞAHİN

Role: STUDY_CHAIR

Namık Kemal University Medicine Faculty

Locations

Namık Kemal University

Tekirdağ, Süleymanpaşa, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Interventional

Identifier Type: -

Identifier Source: org_study_id