Back to resultsRopivacaine Use in Interscalene 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
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
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
Sites / Locations
- Healthpoint Hospital
Outcomes
Primary Outcome Measures
effective analgesic interscalene block
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04833296
Brief Title
Ropivacaine Use in Interscalene Block; What is the Minimal Effective Analgesic Concentration (MEAC 90)
Official Title
Ropivacaine Use in Interscalene 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
5. Study Description
Brief Summary
This study aim to calculate the minimal effective ropivacaine concentration required achieve successful analgesic interscalene block in 90% of patients (MEAC90)
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.
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 interscalene block using same volume of ropivacaine but in different concentrations
Primary Outcome Measure Information:
Title
effective analgesic interscalene block
Description
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
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 shoulder arthroscopy
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 Interscalene Block; What is the Minimal Effective Analgesic Concentration (MEAC 90)
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