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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04834440
• Other study ID #: MF2467-2021-14
• 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

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)

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

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 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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Ropivacaine
all patients will receive femoral nerve 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 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.	in recovery unit (one hour after surgery)