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

NCT04703634 | Completed

• 1 other identifier: Interventional
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Nephrectomy

Keywords

erector spinae block; nephrectomy; ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Recovery analgesia

  24 hours

• postoperative nausea and vomiting

  24 hours

Study Arms (2)

erector spinae group

EXPERIMENTAL

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)

placebo group

PLACEBO COMPARATOR

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)

Interventions

erector spinae block (ESP) PROCEDURE

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

erector spinae group; placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To undergo partial or total nephrectomy surgery
• To be in ASA I-II classification
• To be between the ages of 18-65.
• Not having problems that prevent erector spinae block application such as local anesthetic drug allergy, infection at the injection site, and structural anomaly.
• Being in good mental and psychological health
• To accept to participate in the study.

You may not qualify if:

• Being in ASA III or IV class with a high risk of anesthesia
• Being outside the age range of 18-65
• Having problems such as local anesthetic drug allergy, infection at the injection site, and structural anomaly prevents block application.
• Not being mentally and psychologically healthy
• Those who are allergic to the active substance, patients using antiepileptic drugs
• Those with severe hepatic and renal failure
• Those who have long-term use of nonsteroidal anti-inflammatory and opioid analgesic,
• Those with diabetes and other neuropathic diseases
• Patients who cannot use patient-controlled analgesia (PCA) device

Sponsors & Collaborators

• Namik Kemal University: lead

Study Sites (1)

Namık Kemal University

Tekirdağ, Süleymanpaşa, 59100, Turkey (Türkiye)

Location

Study Officials

• Ayhan ŞAHİN

  Namık Kemal University Medicine Faculty

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Prof

Model Details: It is a single centre, randomized, prospective method comparison study.

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 11, 2021
• Study Start: January 14, 2021
• Primary Completion: May 17, 2021
• Study Completion: May 17, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: starting after 6 months publication
• Access Criteria: After publication, sharing will be made according to the journal criteria.

Locations

TU (1)