Menu
Recruiting NCT07316166

Suprainguinal Fascia Iliaca Block With vs Without Dexmedetomidine

Phase IV Interventional Postoperative Pain Management

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dexmedetomidine, Ropivacaine.
Who it may be relevant to
Registry conditions: Postoperative Pain Management. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparison of Suprainguinal Fascia Iliac Block With and Without Dexmedetomidine as an Adjunct to Ropivacaine for Postoperative Analgesia Following Hip Surgery: a Randomized, Double-blinded Study.

Overview

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.

Detailed 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.

Interventions

  • Drug 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.
  • 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.

Primary outcome measures

  • Time of administration of first analgesic after the surgery [Time frame: Time to first analgesic request, defined as the interval (in minutes) from block administration to the first request for rescue analgesia, assessed for up to 24 hours.]
Secondary outcome measures (3)
  • Total opioid consumption (converted to morphine milligram equivalents) [Time frame: From the start of surgery through 48 hours postoperatively]
  • Quality of Recovery [Time frame: 24 hours]
  • Pain Scores [Time frame: Up to two hours [post anesthesia recovery unit], 6 hours, 12 hours, 24 hours and 48 hours after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • The Miriam Hospital — Providence

Publications

  • Fernandez Martin MT, Alvarez Lopez S, Aldecoa Alvarez-Santullano C. Role of adjuvants in regional anesthesia: A systematic review. Rev Esp Anestesiol Reanim (Engl Ed). 2023 Feb;70(2):97-107. doi: 10.1016/j.redare.2021.06.006. Epub 2023 Feb 20. PMID 36813032
  • Chen A, Duan W, Hao R, Wang C, Xu X. Ultrasound-guided dexmedetomidine combination with modified high fascia iliaca compartment block for arthroscopic knee surgery: what is the optimal dose of dexmedetomidine? BMC Anesthesiol. 2023 Dec 6;23(1):400. doi: 10.1186/s12871-023-02361-0. PMID 38057762
  • Desmet M, Vermeylen K, Van Herreweghe I, Carlier L, Soetens F, Lambrecht S, Croes K, Pottel H, Van de Velde M. A Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty. Reg Anesth Pain Med. 2017 May/Jun;42(3):327-333. doi: 10.1097/AAP.0000000000000543. PMID 28059869
  • Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222. PMID 17403800

Identifiers

NCT: NCT07316166 · 2264738

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗