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

• Sponsor: Healthpoint Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04834440
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 9

Study Details

Study Description

Brief 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)

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Ropivacaine	Phase 4

Detailed 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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Ropivacaine Use in Femoral Nerve Block; What is the Minimal Effective Analgesic Concentration (MEAC 90)
• Anticipated Study Start Date: May 1, 2021
• Anticipated Primary Completion Date: Sep 30, 2021
• Anticipated Study Completion Date: Sep 30, 2021

Outcome Measures

Primary Outcome Measures

1. effective analgesic femoral nerve block [in recovery unit (one hour after surgery)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Healthpoint Hospital	Abu Dhabi		United Arab Emirates	112308

Sponsors and Collaborators

• Healthpoint Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmad Muhammad Taha, Consultant of anesthesia, Healthpoint Hospital
• ClinicalTrials.gov Identifier: NCT04834440
• Other Study ID Numbers: MF2467-2021-14
• First Posted: Apr 8, 2021
• Last Update Posted: Apr 8, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Pain, Postoperative; Ropivacaine

Study Results

No Results Posted as of Apr 8, 2021