NCT04834440

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at below P25 for phase_4 postoperative-pain

Timeline
Completed

Started May 2021

Shorter than P25 for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
23 days until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

5 months

First QC Date

March 31, 2021

Last Update Submit

April 6, 2021

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • 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)

Interventions

RopivacaineDRUG

all patients will receive femoral nerve block using same volume of ropivacaine but in different concentrations

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients, who are scheduled for knee ligament reconstruction

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthpoint Hospital

Abu Dhabi, 112308, United Arab Emirates

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant of anesthesia

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 8, 2021

Study Start

May 1, 2021

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

April 8, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

AE(1)