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Completed

NCT Number: NCT03428633

Thoracic Paravertebral Blocks in Open Nephrectomy

60 patients ASA I-III, undergoing open nephrectomy will be randomly assigned into one of two groups, namely group A (n=30), where a thoracic paravertebral block will be performed preoperatively and a paravertebral catheter for continuous and patient controlled bolus local anesthetic (ropivacaine) doses will be inserted and group B (n=30) where morphine IV will be administered at the beginning and the end of operation and postoperatively through patient controlled IV doses. NRS scores in static and dynamic conditions, complications, patient satisfaction, oxidative stress (through lactic acid, superoxide dismutase, malondialdehyde) and NGAL pre- and postoperatively, will be recorded.

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Key information

Conditions

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

Age range

14 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Asklepieion Hospital of Voula

Athens, 16673, Greece

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Physical status according to American Society of Anesthesiologists (ASA) I-III
  • Patients scheduled for open nephrectomy

Exclusion criteria

  • Previous operation on same kidney
  • Contraindication of paravertebral block or any of the agents used in the protocol
  • BMI above 32
  • Any concurrent malignancy not cured
  • Serious psychiatric, mental and cognitive disorders
  • Block failure
  • Chronic pain
  • Severe kidney disfunction

Treatment and study plan

Ropivacaine

Drug

Paravertebral block using ropivacaine preoperatively and postoperatively

Morphine

Drug

Morphine intraoperatively and postoperatively

Primary outcomes

  1. Postoperative pain

    Time frame: 48 hours

    Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)

  2. Oxidative stress - lactic acid (mmol/L)

    Time frame: 24 hours

  3. Oxidative stress - superoxide dismutase (units/ml)

    Time frame: 24 hours

  4. Oxidative stress - malondialdehyde (nmol/mg protein)

    Time frame: 24 hours

  5. Oxidative stress - neutrophil gelatinase-associated lipocalin (NGAL) (ng/ml)

    Time frame: 24 hours

Secondary outcomes

  1. Complications

    Time frame: 48 hours

  2. Patient satisfaction

    Time frame: 48 hours

    Patients asked whether they would choose the same anaesthetic management in a future operation: Yes/No

  3. Patient mobilization

    Time frame: 7 days

    Patient reporting time of first standing to the side of the bed

  4. Intestinal function

    Time frame: 7 days

    Time of first passing of rectal gas, reported by the patient

  5. Chronic pain

    Time frame: 6 months

    Using of Graded Chronic Pain Scale (GCPS) Grade 0: No pain in prior 6 months Grade 1: Low Intensity - Low Disability Grade II: High Intensity Characteristic Pain Intensity - Low Disability Grade III: High Disability - Moderately Limiting Grade IV: High Disability - Severely Limiting

Sponsors and collaborators

Lead sponsor

Asklepieion Voulas General Hospital

Other Gov

Collaborators

  • Chryssoula Staikou
  • Ioannis Karavokyros
  • Michail Tsagkaris

Registry information

Official study title

Thoracic Paravertebral Blocks in Open Nephrectomy. A Prospective, Randomized Study of Block Efficacy and Influence on Oxidative Stress and Patient Outcome.

Important dates

Study start
2018
Primary completion
2021
Study completion
2023
First posted
Feb 9, 2018
Registry last updated
Oct 13, 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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