Suprainguinal Fascia Iliaca Block With vs Without Dexmedetomidine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-08

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postoperative Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Ropivacaine

30 ml of 0.25% ropivacaine; No dexmedetomidine

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

In the experimental arm, ropivacaine (30 mL of 0.25%) is administered with dexmedetomidine.

In the active comparator arm, ropivacaine (30 mL of 0.25%) is administered alone without any dexmedetomidine medication.

Ropivacaine plus Dexmedetomidine

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

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Participants in the experimental arm receive a preoperative suprainguinal fascia iliaca block consisting of 30 mL of 0.25% ropivacaine combined with perineural dexmedetomidine at a dose of 1 mcg/kg.

Ropivacaine

Intervention Type DRUG

In the experimental arm, ropivacaine (30 mL of 0.25%) is administered with dexmedetomidine.

In the active comparator arm, ropivacaine (30 mL of 0.25%) is administered alone without any dexmedetomidine medication.

Interventions

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Dexmedetomidine

Participants in the experimental arm receive a preoperative suprainguinal fascia iliaca block consisting of 30 mL of 0.25% ropivacaine combined with perineural dexmedetomidine at a dose of 1 mcg/kg.

Intervention Type DRUG

Ropivacaine

In the experimental arm, ropivacaine (30 mL of 0.25%) is administered with dexmedetomidine.

In the active comparator arm, ropivacaine (30 mL of 0.25%) is administered alone without any dexmedetomidine medication.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No