Thoracic Paravertebral Blocks in Open Nephrectomy

Phase 2

Completed

• Conditions: Nephrectomy; Analgesia
• Interventions: Drug: Ropivacaine; Drug: Morphine

• Registration Number: NCT03428633
• Lead Sponsor: Asklepieion Voulas General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-01
• Study First Submitted QC: 2018-02-08
• Study First Posted: 2018-02-09
• Study Start: 2018-03-09
• Primary Completion: 2021-02-01
• Study Completion: 2023-02-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-12
• Last Update Posted: 2023-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Ropivacaine	Thoracic paravertebral block using ropivacaine
Group B	Morphine	Morphine IV

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Asklepieion Hospital of Voula; 🇬🇷 Athens, Greece