Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT07023120
Eligibility Criteria:
Inclusion Criteria:
* Adults aged ≥18 years scheduled for primary unilateral total hip arthroplasty (THA).
* American Society of Anesthesiologists (ASA) physical status I-III.
* Ability to provide written informed consent.
* Spinal anesthesia planned as the primary anesthetic technique.
* Body mass index (BMI) between 18 and 35 kg/m².
* Fluent in the local language and able to understand the NRS pain scoring system.
Exclusion Criteria:
* Known allergy or hypersensitivity to ropivacaine, dexamethasone, or other amide local anesthetics.
* Pre-existing neurological deficits or neuropathies affecting lower limb motor or sensory function.
* Chronic opioid use (daily use \>30 mg oral morphine equivalents for \>1 month prior to surgery).
* History of coagulopathy, current anticoagulant therapy not eligible for regional anesthesia.
* Uncontrolled diabetes mellitus (HbA1c \> 9%) or active systemic infection.
* Pregnancy or breastfeeding.
* Previous surgery or implantation on the ipsilateral hip.
* Inability to cooperate with postoperative assessments or participate in follow-up.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
100 Years
Study:
NCT07023120
Study Brief:
Protocol Section:
NCT07023120