MedPath

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

Not Applicable
Completed
Conditions
Nephrectomy
Interventions
Procedure: erector spinae block (ESP)
Registration Number
NCT04703634
Lead Sponsor
Namik Kemal University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
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

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
erector spinae grouperector spinae block (ESP)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.
placebo grouperector spinae block (ESP)No block transaction will be applied to this group. Only postoperative analgesia methods will be used for this group as specified in the protocol.
Primary Outcome Measures
NameTimeMethod
Numerical Rating Scale (NRS)24 hours

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").

Secondary Outcome Measures
NameTimeMethod
Recovery analgesia24 hours

Secondary outcome measures will be routine (paracetamol or tramadol PCA) or recovery. Analgesic use will be recorded within the first 24 hours.

postoperative nausea and vomiting24 hours

The severity of nausea and vomiting 4-point scale (none, mild, moderate, and severe). As will be recorded by the nurses in the ward.

Trial Locations

Locations (1)

Namık Kemal University

🇹🇷

Tekirdağ, Süleymanpaşa, Turkey

© Copyright 2025. All Rights Reserved by MedPath