Thoracic Paravertebral Blocks in Open Nephrectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Nephrectomy
• Intervention / Treatment: Drug: Ropivacaine; Drug: Morphine

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 16673
    • Asklepieion Hospital of Voula

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Thoracic paravertebral block using ropivacaine	Drug: Ropivacaine; Paravertebral block using ropivacaine preoperatively and postoperatively
Active Comparator: Group B; Morphine IV	Drug: Morphine; Morphine intraoperatively and postoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Patients asked whether they would choose the same anaesthetic management in a future operation: Yes/No	48 hours
Chronic pain	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	6 months
Complications		48 hours
Patient mobilization	Patient reporting time of first standing to the side of the bed	7 days
Intestinal function	Time of first passing of rectal gas, reported by the patient	7 days

Collaborators and Investigators

• Sponsor: Asklepieion Voulas General Hospital
• Collaborators: Chryssoula Staikou; Michail Tsagkaris; Ioannis Karavokyros

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2018
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (Actual): February 9, 2018

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Ropivacaine; Morphine
• Other Study ID Numbers: AsklepieionVGH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No