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

April 3, 2021 updated by: Ahmad Muhammad Taha, Healthpoint Hospital
This study aim to calculate the minimal effective ropivacaine concentration required achieve successful analgesic interscalene block in 90% of patients (MEAC90)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

  • Before induction of general anesthesia, all patients will receive interscalene block using 15ml of ropivacaine which concentration will be based on the response of the previous patient.
  • Based on biased-coin design up-down sequential method: if patient has pain free recovery, a successful block, the next patient will be randomized to receive either the same ropivacaine concentration or a concentration 0.01% w/v less. However, if he has an unsuccessful block, the next patient will receive a concentration 0.01% w/v higher.
  • Patients with pain free recovery will be considered to have positive response.
  • Patients' responses will be analyzed to calculate the MEAC90.

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients, who are scheduled for shoulder arthroscopy

Exclusion Criteria:

  • - <18 y,

  • ASA physical class greater >III

    • BMI >40 has any contraindication for medications or techniques used in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effective analgesic interscalene block
Time Frame: in recovery unit (one hour after surgery)
postoperative pain (will be assessed using numerical rating scale. if ≥ 3, ineffective block will be considered and if <3, an effective block will be considered
in recovery unit (one hour after surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Healthpoint Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2021

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

March 31, 2021

First Submitted That Met QC Criteria

April 3, 2021

First Posted (Actual)

April 6, 2021

Study Record Updates

Last Update Posted (Actual)

April 6, 2021

Last Update Submitted That Met QC Criteria

April 3, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MF2467-2021-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Pain

Clinical Trials on Ropivacaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe