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Completed

NCT Number: NCT04703634

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

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.

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Key information

Conditions

Nephrectomy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Namık Kemal University

Tekirdağ, Süleymanpaşa, 59100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

erector spinae block (ESP)

Procedure

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

Primary outcomes

  1. Numerical Rating Scale (NRS)

    Time frame: 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 outcomes

  1. Recovery analgesia

    Time frame: 24 hours

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

  2. postoperative nausea and vomiting

    Time frame: 24 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.

Sponsors and collaborators

Lead sponsor

Namik Kemal University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 11, 2021
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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