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Completed

NCT Number: NCT05892887

Analgesic Efficacy of Different Volumes in Erector Spinae Plane Block in Single Level Lumbar Spine Fixation

The analgesic efficacy of different volumes in ESPB patients undergoing single-level lumbar spine fixation

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Key information

Conditions

Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

About this study

The erector spinae plane block (ESPB) its an interfacial plane block for an effective treatment for thoracic neuropathic pain. Currently, compared to the use of opioids, the ESPB has fewer side effects and is safe for patients of all ages having abdominal and thoracic operations .

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18-65 years.
  • Both genders.
  • American Society of Anesthesiologists' (ASA) physical status I or II.
  • Undergoing single level lumbar spine fixation.

Exclusion criteria

  • Patient refusal.
  • Pregnant females.
  • Renal, lung, heart, or liver disorders.
  • Communication difficulties which might prevent a reliable postoperative assessment.
  • Contraindication to regional anesthesia (bleeding disorder, use of any anticoagulants, local infection, known allergy to local anesthetics).
  • BMI more than 30 kg/m2.

Treatment and study plan

Bupivacaine 0.25% Injectable Solution

Drug

Bilateral ultrasound guided in erector spinae plane block by bupivacaine 0.25%

Primary outcomes

  1. Total morphine consumption

    Time frame: First 24 hours postoperatively

    Patients were allowed to receive incremental doses of morphine 3mg intravenously if numerical rating scale pain score will be ≥ then the total amount of morphine will be recorded

Secondary outcomes

  1. Numerical rating scale

    Time frame: Up to 48 hours postoperatively

    Postoperative pain using numerical rating scale (NRS) will be measured at post-anesthesia care unit, from 0 to 10, with 0 representing no pain and 10 representing maximum intolerable pain

  2. Time to the first rescue analgesic

    Time frame: Up to 24 hours postoperatively

    If numerical rating scale >4 was observed, rescue analgesia (morphine 3 mg IV) was administered

  3. Postoperative complications

    Time frame: Up to 24 hours postoperatively

    postoperative nausea and vomiting (PONV), hypotension (mean arterial pressure < 20% of baseline readings and was managed by ephedrine 5 mg IV and/or normal saline IVI), bradycardia (heart rate < 60 beats/min and was managed by atropine 0.6 mg IV).

  4. 5-point scale

    Time frame: Up to 24 hours postoperative

    The degree of patient satisfaction was assessed on a 5-point scale: (0= extremely dissatisfied, 1= unsatisfied, 2= neither satisfied nor unsatisfied, 3= satisfied), and 4= extremely satisfied).

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

Analgesic Efficacy of Different Volumes in Erector Spinae Plane Block in Patients Undergoing Single Level Lumbar Spine Fixation: A Non-inferiority Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 7, 2023
Registry last updated
Oct 10, 2023

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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