NCT05072704

Brief Summary

Total hip arthroplasty (THA) is one of the most common orthopedic surgical procedure and is associated with severe pain in the immediate postoperative period, thus limiting early recovery. Postoperative pain management in THA requires multimodal analgesia, combining drugs and injection of a local anesthetic (LA). But, the best anesthesia strategy to provide optimal postoperative analgesia in THA remains controversial. Opioid free anesthesia could limit the episodes of hyperalgesia as well as tolerance and addiction to opioids. The hypothesis of this study is that an opioid free anesthesia using dexmedetomidine could improve analgesia after THA. The main objective of this monocenter, prospective, randomized, triple-blind, controlled trial is to assess the interest of opioid free anesthesia using dexmedetomidine on morphine consumption after THA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2022

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 17, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 11, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

February 3, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2023

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

September 17, 2021

Last Update Submit

April 2, 2026

Conditions

Primary Total Hip Arthroplasty

Keywords

Hip arthroplastyOpioid free anesthesiaDexmedetomidinePostoperative analgesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative analgesia, defined by the oxycodone consumption in the first 24 hours post-surgery

    Postoperative cumulated dose of oxycodone in oral morphine equivalent (mg)

    24 hours

Secondary Outcomes (8)

  • Analgesia in post-anesthesia care unit (PACU)

    6 hours

  • Postoperative pain at rest

    24 hours

  • Postoperative pain at walk

    24 hours

  • Side effects associated with opioids

    24 hours

  • Side effects associated with dexmedetomidine

    24 hours

  • +3 more secondary outcomes

Study Arms (2)

Control group

ACTIVE COMPARATOR

Sufentanil IV injection

Drug: Sufentanil

OFA group

EXPERIMENTAL

Dexmedetomidine IV infusion

Drug: Dexmedetomidine

Interventions

SufentanilDRUG

Pre-operative injection of sufentanil 10µg in 2ml of normal saline on induction of anesthesia + per-operative injection of sufentanil 5µg in 1ml of normal saline during the surgery if needed.

Control group
DexmedetomidineDRUG

Pre-operative infusion of dexmedetomidine 1µg/kg in 100ml of normal saline before surgery + per-operative infusion of dexmedetomidine 0.4 µg/kg in 100ml of normal saline during the surgery if needed.

OFA group

Eligibility Criteria

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

You may qualify if:

  • years and older,
  • Undergoing outpatient primary total hip arthroplasty under general anesthesia with laryngeal mask,
  • Consent for participation,
  • Affiliation to a social security system

You may not qualify if:

  • Heart rate \< 60 bpm
  • Chronic pain syndrome requiring preoperative morphine use (class 3)
  • Contraindication for: paracetamol, ketoprofen, nefopam, oxycodone, propofol, ketamine, cisatracurium, sufentanyl, ropivacaine.
  • Contraindication for dexmedetomidine: hypersensitivity to the active substance or to any of the excipients, advanced cardiac block (grade 2 or 3) unless paced ; uncontrolled hypotension ; acute cerebrovascular conditions
  • Contraindication to laryngeal mask : old insulin-dependent diabetes, gastro-oesophageal reflux, morbid obesity (defined by BMI \> 35)
  • Pregnant or breastfeeding women
  • Women of child bearing potential without contraception (any contraceptive method used regularly and appropriately with a low failure rate: \<1% per year),
  • A mental or linguistic inability to understand the study,
  • Patient under protection of the adults (guardianship, curators or safeguard of justice),
  • Patient included or planning to be included in another clinical trial relating to medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Médipôle Garonne

Toulouse, Haute-Garonne, 31036, France

Location

Related Publications (1)

  • Chassery C, Atthar V, Marty P, Vuillaume C, Casalprim J, Basset B, De Lussy A, Naudin C, Joshi GP, Rontes O. Opioid-free versus opioid-sparing anaesthesia in ambulatory total hip arthroplasty: a randomised controlled trial. Br J Anaesth. 2024 Feb;132(2):352-358. doi: 10.1016/j.bja.2023.10.031. Epub 2023 Dec 2.

    PMID: 38044236RESULT

MeSH Terms

Interventions

SufentanilDexmedetomidine

Intervention Hierarchy (Ancestors)

FentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsImidazolesAzoles

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2021

First Posted

October 11, 2021

Study Start

February 3, 2022

Primary Completion

February 2, 2023

Study Completion

February 2, 2023

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)