Thoracic Paravertebral Blocks in Open Nephrectomy | NCT03428633

Studies
Thoracic Paravertebral Blocks in Open Nephrectomy

NCT03428633

Sponsor

Asklepieion Voulas General Hospital

Status

Completed

Last Update Posted

Oct 13, 2023Actual

Enrollment

60Actual

Phase

Phase 2

Conditions

Nephrectomy
Analgesia

Interventions

Ropivacaine
Morphine

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 9, 2018Actual

Primary Completion Date

Feb 1, 2021Actual

Completion Date

Feb 1, 2023Actual

First Submitted Date

Feb 1, 2018

First Submission Date that Met QC Criteria

Feb 8, 2018

First Posted Date

Feb 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2023

Last Update Posted Date

Oct 13, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alexandros Makris, Consultant Anaesthesiologist, Asklepieion Voulas General HospitalPrincipal Investigator

Lead Sponsor

Asklepieion Voulas General HospitalOTHER_GOV

Collaborators

Name	Class
Michail Tsagkaris	UNKNOWN
Chryssoula Staikou	UNKNOWN
Ioannis Karavokyros	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Active Comparator	Thoracic paravertebral block using ropivacaine	Drug: Ropivacaine
Group B	Active Comparator	Morphine IV	Drug: Morphine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ropivacaine	Drug	Paravertebral block using ropivacaine preoperatively and postoperatively	Group A

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Complications		48 hours
Patient satisfaction	Patients asked whether they would choose the same anaesthetic management in a future operation: Yes/No	48 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asklepieion Hospital of Voula		Athens		16673	Greece

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000377	Agnosia

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077212	Ropivacaine
D009020	Morphine

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided