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

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

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.

Study Overview

• Status: Completed
• Conditions: Nephrectomy
• Intervention / Treatment: Procedure: erector spinae block (ESP)

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Süleymanpaşa
    • Tekirdağ, Süleymanpaşa, Turkey, 59100
      • Namık Kemal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Procedure: erector spinae block (ESP); Administration of local anesthetic under the erector spinae muscle just below the transverse process of the thoracic 12th vertebra
PLACEBO_COMPARATOR: 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.	Procedure: erector spinae block (ESP); Administration of local anesthetic under the erector spinae muscle just below the transverse process of the thoracic 12th vertebra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Namik Kemal University
• Investigators: Study Chair: Ayhan ŞAHİN, Namık Kemal University Medicine Faculty

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 14, 2021
• Primary Completion (ACTUAL): May 17, 2021
• Study Completion (ACTUAL): May 17, 2021

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: January 8, 2021
• First Posted (ACTUAL): January 11, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: ultrasound; nephrectomy; erector spinae block
• Other Study ID Numbers: Interventional (Oncolys BioPharma Inc)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Participant data will be shared as much as the tasks described in the study. A meeting will be held at the end of the research, and the statistical data results will be shared. Dr. Ayhan Şahin is responsible.
• IPD Sharing Time Frame: starting after 6 months publication
• IPD Sharing Access Criteria: After publication, sharing will be made according to the journal criteria.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No