Thoracic Paravertebral Blocks in Open Nephrectomy

NCT03428633 | Completed Phase 2 DMC

• 1 other identifier: AsklepieionVGH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nephrectomy; Analgesia

Outcome Measures

Primary Outcomes (5)

• Postoperative pain

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

  48 hours

• Oxidative stress - lactic acid (mmol/L)

  24 hours

• Oxidative stress - superoxide dismutase (units/ml)

  24 hours

• Oxidative stress - malondialdehyde (nmol/mg protein)

  24 hours

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

  24 hours

Secondary Outcomes (5)

• Complications

  48 hours

• Patient satisfaction

  48 hours

• Patient mobilization

  7 days

• Intestinal function

  7 days

• Chronic pain

  6 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

Thoracic paravertebral block using ropivacaine

Drug: Ropivacaine

Group B

ACTIVE COMPARATOR

Morphine IV

Drug: Morphine

Interventions

Ropivacaine DRUG

Paravertebral block using ropivacaine preoperatively and postoperatively

Group A

Morphine DRUG

Morphine intraoperatively and postoperatively

Group B

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asklepieion Voulas General Hospital: lead
• Michail Tsagkaris: collaborator
• Chryssoula Staikou: collaborator
• Ioannis Karavokyros: collaborator

Study Sites (1)

Asklepieion Hospital of Voula

Athens, 16673, Greece

Location

MeSH Terms

Conditions

Agnosia

Interventions

Ropivacaine; Morphine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthesiologist

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 9, 2018
• Study Start: March 9, 2018
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2023
• Last Updated: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)