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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04834440
Enrollment
45
Registered
2021-04-08
Start date
2021-05-01
Completion date
2021-09-30
Last updated
2021-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

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)

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

Interventions

DRUGRopivacaine

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

Sponsors

Healthpoint Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
effective analgesic femoral nerve blockin 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.

Countries

United Arab Emirates

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026