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

NCT ID: NCT04833296

Last Updated: 2021-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2021-09-30

Brief Summary

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This study aim to calculate the minimal effective ropivacaine concentration required achieve successful analgesic interscalene block in 90% of patients (MEAC90)

Detailed Description

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* 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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Ropivacaine

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Healthpoint Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ahmad Muhammad Taha

Consultant of anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Healthpoint Hospital

Abu Dhabi, , United Arab Emirates

Site Status

Countries

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United Arab Emirates

Other Identifiers

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MF2467-2021-15

Identifier Type: -

Identifier Source: org_study_id

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