Ropivacaine Use in Femoral Nerve Block; What is the Minim... | NCT04834440

Studies
Ropivacaine Use in Femoral Nerve Block; What is the Minimal Effective Analgesic Concentration (MEAC 90)

NCT04834440

Sponsor

Healthpoint Hospital

Status

Unknown status

Last Update Posted

Apr 8, 2021Actual

Enrollment

45Estimated

Phase

Phase 4

Conditions

Postoperative Pain

Interventions

Ropivacaine

Countries

United Arab Emirates

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

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2021Estimated

Primary Completion Date

Sep 30, 2021Estimated

Completion Date

Sep 30, 2021Estimated

First Submitted Date

Mar 31, 2021

First Submission Date that Met QC Criteria

Apr 3, 2021

First Posted Date

Apr 8, 2021Actual

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

Apr 6, 2021

Last Update Posted Date

Apr 8, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to determine the minimal effective ropivacaine concentration required to provide adequate analgesic femoral nerve block in 90% of patients (MEAC90)

Detailed Description

Before induction of GA, all patients will receive sciatic, obturator, lateral femoral cutaneous and femoral nerve blocks.
The femoral nerve block will be performed using 15ml of ropivacaine which concentration relied on the response of the previous patient.
Based on biased-coin design up-down sequential method: when a patient has a negative response, the next patient will receive a concentration 0.01% w/v higher. However if he has a positive response, the next patient will be randomized to receive either the same ropivacaine concentration or a concentration 0.01% w/v less.
Patients with pain free recovery will be considered to have positive response.
Patients' responses will be analyzed to calculate the MEAC90

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ropivacaine	Drug	all patients will receive femoral nerve block using same volume of ropivacaine but in different concentrations

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
effective analgesic femoral nerve block	postoperative pain. it will be assessed using numerical rating scale (NRS). NRS, 0 = no pain; 10 = worst pain imaginable; if NRS ≥ 3, pain (ineffective block) is considered, other wise a successful block will be considered.	in recovery unit (one hour after surgery)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients, who are scheduled for knee ligament reconstruction

Exclusion Criteria:

<18 y,
ASA physical class greater >III
- BMI >40 has any contraindication for medications or techniques used in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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
Healthpoint Hospital		Abu Dhabi		112308	United Arab Emirates

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
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077212	Ropivacaine

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided