Thoracic Paravertebral Blocks in Open Nephrectomy

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03428633
• Other study ID #: AsklepieionVGH
• Status: Completed
• Phase: Phase 2
• Start date: March 9, 2018
• Est. completion date: February 1, 2023

Study information

• Verified date: October 2023
• Source: Asklepieion Voulas General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Nephrectomy

Intervention

Drug:
• Ropivacaine
Paravertebral block using ropivacaine preoperatively and postoperatively
• Morphine
Morphine intraoperatively and postoperatively

Locations

Country	Name	City	State
Greece	Asklepieion Hospital of Voula	Athens

Sponsors (4)

Lead Sponsor	Collaborator
Asklepieion Voulas General Hospital	Chryssoula Staikou, Ioannis Karavokyros, Michail Tsagkaris

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)	48 hours
Primary	Oxidative stress - lactic acid (mmol/L)		24 hours
Primary	Oxidative stress - superoxide dismutase (units/ml)		24 hours
Primary	Oxidative stress - malondialdehyde (nmol/mg protein)		24 hours
Primary	Oxidative stress - neutrophil gelatinase-associated lipocalin (NGAL) (ng/ml)		24 hours
Secondary	Complications		48 hours
Secondary	Patient satisfaction	Patients asked whether they would choose the same anaesthetic management in a future operation: Yes/No	48 hours
Secondary	Patient mobilization	Patient reporting time of first standing to the side of the bed	7 days
Secondary	Intestinal function	Time of first passing of rectal gas, reported by the patient	7 days
Secondary	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