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

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Phase 4
Locations
United Arab Emirates
Study Type
Interventional
Intervention
Ropivacaine
Sponsored by
Healthpoint Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Healthpoint Hospital

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 31, 2021
Last Updated
April 6, 2021
Sponsor
Healthpoint Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04834440
Brief Title
Ropivacaine Use in Femoral Nerve Block; What is the Minimal Effective Analgesic Concentration (MEAC 90)
Official Title
Ropivacaine Use in Femoral Nerve Block; What is the Minimal Effective Analgesic Concentration (MEAC 90)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2021 (Anticipated)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Healthpoint Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
all patients will receive femoral nerve block using same volume of ropivacaine but in different concentrations
Primary Outcome Measure Information:
Title
effective analgesic femoral nerve block
Description
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.
Time Frame
in recovery unit (one hour after surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Healthpoint Hospital
City
Abu Dhabi
ZIP/Postal Code
112308
Country
United Arab Emirates

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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