Suprainguinal Fascia Iliaca Block With vs Without Dexmedetomidine

Lifespan

Status and phase: Enrolling; Phase 4

Conditions: Postoperative Pain Management

Treatments: Drug: Dexmedetomidine; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT07316166

2264738

Details and patient eligibility

About

The investigators are evaluating postoperative outcomes in patients undergoing hip replacement surgery performed with either spinal or general anesthesia, who also receive a suprainguinal fascia iliaca block using either perineural ropivacaine alone or ropivacaine combined with dexmedetomidine.

Full description

Patients undergoing hip replacement surgery often receive a single-shot suprainguinal fascia iliaca block as a part of the primary anesthetic and multimodal postoperative analgesic strategy. However, the analgesic effect of a single-shot block typically diminishes after several hours and may be inconsistent beyond 24 hours. Adding dexmedetomidine, an alpha-2 agonist, to the local anesthetic has been shown to prolong block duration and reduce postoperative opioid requirements. Investigating its use in suprainguinal fascia iliaca blocks for total hip arthroplasty may clarify its clinical effectiveness. The investigators hypothesize that patients receiving ropivacaine with dexmedetomidine will have a significantly longer time to first analgesic request compared to those receiving ropivacaine alone.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing elective total hip arthroplasty
• 18-80 years old
• ASA 1-3 classifications

Exclusion criteria

• ASA classification of 4 or greater
• Infection at the site of nerve blockade
• Coagulopathy
• Known allergy to study medications
• Chronic opioid consumption (>3 months)
• Currently using lidocaine patches
• Pre-existing neuropathy
• A history of CVA
• High grade atrioventricular block (cardiac conduction system impairment)
• Organ dysfunction (cardiac failure, respiratory failure, end stage renal disease, hepatic dysfunction, hypoalbuminemia)
• Morbid obesity (≥40 kg/m2)
• Prior surgery in supra and/or infrainguinal region
• Non-English-speaking participants

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

120 participants in 2 patient groups

Ropivacaine

Active Comparator group

Description:

30 ml of 0.25% ropivacaine; No dexmedetomidine

Treatment:

Drug: Ropivacaine

Ropivacaine plus Dexmedetomidine

Experimental group

Description:

30 ml of 0.25% ropivacaine; 1 mcg/kg of dexmedetomidine

Treatment:

Drug: Ropivacaine

Drug: Dexmedetomidine