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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04833296
• Other study ID #: MF2467-2021-15
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 1, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: April 2021
• Source: Healthpoint Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Ropivacaine
all patients will receive interscalene block using same volume of ropivacaine but in different concentrations

Locations

Country	Name	City	State
United Arab Emirates	Healthpoint Hospital	Abu Dhabi

Sponsors (1)

Lead Sponsor	Collaborator
Healthpoint Hospital

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	in recovery unit (one hour after surgery)