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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03428633

Enrollment

Registered

2018-02-09

Start date

2018-03-09

Completion date

2023-02-01

Last updated

2023-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Nephrectomy

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.

Interventions

DRUGRopivacaine

Paravertebral block using ropivacaine preoperatively and postoperatively

DRUGMorphine

Morphine intraoperatively and postoperatively

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

14 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Oxidative stress - neutrophil gelatinase-associated lipocalin (NGAL) (ng/ml)	24 hours	—
Postoperative pain	48 hours	Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)
Oxidative stress - lactic acid (mmol/L)	24 hours	—
Oxidative stress - superoxide dismutase (units/ml)	24 hours	—
Oxidative stress - malondialdehyde (nmol/mg protein)	24 hours	—

Secondary

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

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026