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NCT Number: NCT07672600

The Effect of Ultrasound-Guided Erector Spinae Plane Block on Postoperative Analgesia in Percutaneous Nephrolithotomy

This study is planned as a single-center randomized single blinded study and includes patients undergoing percutaneous nephrolitotomy.The aim of the study is to evaluate the effect of ultrasound guided erector spinal plane block on postoperative analgesia in percutaneous nephrolitotomy. Primary outcome is the total 24 hour morphine consumption.

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Key information

Conditions

Acute Postoperative Pain in Urological Surgery Regional Anaesthesia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University, Istanbul Faculty of Medicine

Istanbul, Fatih, 34093, Turkey (Türkiye)

About this study

Adult patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-II scheduled for elective PCNL were allocated to receive either a unilateral ultrasound-guided ESPB at the T9 level with 20 mL of 0.25% bupivacaine followed by postoperative IV morphine PCA (Group ESPB ) or postoperative IV morphine PCA alone (Group C). 24 hour morphine consumption, numeric Rating Scale (NRS) pain scores, rescue analgesic requirements, sedation scores, opioid-related adverse effects, hospital stay, chronic pain, patient and surgeon satisfaction are recorded.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Elective percutaneous nephrolitotomy
  • American Society of Anesthesiologists (ASA) physical status I-II

Exclusion criteria

  • Refusal to participate
  • Coagulopathy,
  • Infection at the block site
  • Allergy to local anaesthetics
  • Previous surgery in the block area
  • Severe systemic disease.

Treatment and study plan

Erector Spinae Plane Block

Procedure

Erector spinae plane block is applied in longitudinal plane at T9 level.

Intravenous analgesia

Procedure

Inravenous morphine is administered via patient controlled analgesia device.

Primary outcomes

  1. Total 24-hour morphine consumption

    Time frame: 24 hours

    Total 24-hour intravenous morphine consumption via patient controlled analgesia device

Secondary outcomes

  1. Pain assessment

    Time frame: 24 hours

    Pain assessment is evaluated using numeric rating scale (NRS 0-10; 0: no pain, 10: the worst pain imaginable)

  2. Additional analgesic requirement

    Time frame: 24 hours

    If the Numeric Rating Scale (NRS) score exceeded 4, rescue analgesia consisted of additional morphine 0.02 mg/kg, plus intravenous paracetamol 1 g.

  3. Postoperative nausea and vomiting

    Time frame: 24 hours

    Number of patients experienced postoperative nausea and vomiting .

  4. Patient satisfaction

    Time frame: Up to 24 hours

    Patient satisfaction is questioned using Likert scale:1-3 (1: dissatisfied, 2: neutral, 3: satisfied)

  5. Surgeon satisfaction

    Time frame: Up to 24 hours

    Surgeon satisfaction is questioned using Likert scale:1-3 (1: dissatisfied, 2: neutral, 3: satisfied)

  6. First rescue analgesic time

    Time frame: 24 hours

    The first time patient required rescue analgesic

  7. Length of hospital stay

    Time frame: Up to 1 week

    Length of hospital stay

  8. Chronic pain

    Time frame: 3 months

    Chronic pain is evaluated using NRS scores

  9. Pruritus

    Time frame: 24 hours

    The number of patients experienced pruritus

  10. Chronic pain

    Time frame: 3 months

    Chronic pain is evaluated using DN4 questionnaire

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

The Effect of Ultrasound-Guided Erector Spinae Plane Block on Postoperative Analgesia in Percutaneous Nephrolithotomy: a Randomised Single-blind Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 29, 2026
Registry last updated
Jul 8, 2026

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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