NCT07316166

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
12mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Jan 2026Jun 2027

First Submitted

Initial submission to the registry

December 5, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 5, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

January 20, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

December 5, 2025

Last Update Submit

March 24, 2026

Conditions

Keywords

Hip SurgeryNerve block

Outcome Measures

Primary Outcomes (1)

  • Time of administration of first analgesic after the surgery

    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 Outcomes (3)

  • Total opioid consumption (converted to morphine milligram equivalents)

    From the start of surgery through 48 hours postoperatively

  • Quality of Recovery

    24 hours

  • Pain Scores

    Up to two hours [post anesthesia recovery unit], 6 hours, 12 hours, 24 hours and 48 hours after surgery

Study Arms (2)

Ropivacaine

ACTIVE COMPARATOR

30 ml of 0.25% ropivacaine; No dexmedetomidine

Drug: Ropivacaine

Ropivacaine plus Dexmedetomidine

EXPERIMENTAL

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

Drug: DexmedetomidineDrug: Ropivacaine

Interventions

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 plus Dexmedetomidine

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.

RopivacaineRopivacaine plus Dexmedetomidine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

RECRUITING

Related Publications (4)

  • 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: 36813032BACKGROUND
  • 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: 38057762BACKGROUND
  • 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: 28059869BACKGROUND
  • 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: 17403800BACKGROUND

MeSH Terms

Interventions

DexmedetomidineRopivacaine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Vendhan Ramanujam, M.D.

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 5, 2025

First Posted

January 5, 2026

Study Start

January 20, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations