Primary Total Hip ArthroplastyPhase 3OFATHANCT05072704
Opioid Free Anesthesia in Total Hip Arthroplasty
A Phase 3 study testing Sufentanil and Dexmedetomidine in people with Primary Total Hip Arthroplasty, run by CMC Ambroise Paré at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Total Hip Arthroplasty
- What is being tested?
- Sufentanil and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2022to 2 Feb 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older,
- Undergoing outpatient primary total hip arthroplasty under general anesthesia with laryngeal mask,
- Consent for participation,
- Affiliation to a social security system
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Opioid Free Anesthesia in Total Hip Arthroplasty. A Randomized, Controlled and Triple-blind Clinical Trial
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.
Read more
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.
Read the detailed description
In the pre-anaesthesia room, after the implementation of classical monitoring and a peripheral venous catheter, all patients will receive an antibioprophylaxis according to SFAR (French Society of Anesthesia \& Intensive Care Medecine) recommendations and injection of 10 mg of IV dexamethasone.
The patients will be then randomized in 2 groups:
Control group:
- Pre-operative normal saline infusion 100 ml over 30 minutes
- Injection of sufentanil 10 µg in normal saline 2 ml on induction of anesthesia
If needed after incision :
- Per-operative normal saline infusion 100 ml
- Per-operative injection of sufentanil 5 µg in normal saline 1 ml
OFA group (experimental group):
- Pre-operative dexmedetomidine infusion 1 µg/kg in normal saline 100 ml over 30 minutes
- Injection of normal saline 2 ml on induction of anesthesia
If needed after incision :
- Per-operative dexmedetomidine infusion 0.4 µg/kg in normal saline 100 ml
- Per-operative injection of normal saline 1 ml
In the operating room, general anesthesia will be induced by intravenous ketamine (0.4 mg/kg) + propofol (3 mg/kg) +/- cisatracurium (0.1 mg/kg) for the introduction of laryngeal mask airway. Anesthesia will be maintained with propofol.
Postoperative analgesia protocol :
- Multimodal analgesia will be instituted during surgery by the administration of paracetamol (1 g), nefopam (20 mg) and ketoprofen (100 mg) and the infiltration of the surgical wound with 100 ml of ropivacaine 0.2%.
- In post-anesthesia care unit (PACU): oxycodone titration if NRS (pain score) >3 according to the centre's usual care.
- In ward and at home: systematic per os analgesia with paracetamol (1 g, 4 times a day) and ibuprofen (400 mg, 3 times a day); oxycodone (10 mg, lockout interval: 4 h) if NRS (pain score) >3.
- Conditions
- Primary Total Hip Arthroplasty
- Being tested
- Sufentanil, Dexmedetomidine
- Keywords
- Hip arthroplasty, Opioid free anesthesia, Dexmedetomidine, Postoperative analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Sufentanil IV injection Receives: Drug: Sufentanil |
| OFA group | Experimental | Dexmedetomidine IV infusion Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative analgesia, defined by the oxycodone consumption in the first 24 hours post-surgery
Postoperative cumulated dose of oxycodone in oral morphine equivalent (mg)
Measured: 24 hours
Secondary outcomes (8)
Analgesia in post-anesthesia care unit (PACU)
Total amount of oxycodone (mg) administered in PACU
Measured: 6 hours
Postoperative pain at rest
Postoperative pain at rest (numeric rating scale ranging from 0 to 10: 0= no pain; 10= worst imaginable pain)
Measured: 24 hours
Postoperative pain at walk
Postoperative pain at mobilization (numeric rating scale ranging from 0 to 10: 0= no pain; 10= worst imaginable pain)
Measured: 24 hours
Side effects associated with opioids
Complications due to oxycodone (postoperative nausea and vomiting, drowsiness, acute urinary retention, pruritus, disorientation)
Measured: 24 hours
Side effects associated with dexmedetomidine
Complications due to dexmedetomidine (bradycardia defined by HR<50 bpm or requiring the use of atropine; hypotension defined by SBP<90 mmHg or requiring the use of vasoconstrictors; hypertension defined by SBP>160 mmHg).
Measured: 24 hours
Outpatient care failure
Unplanned hospitalizations
Measured: 24 hours
Length of stay in post-anesthesia care unit (PACU)
Duration of PACU stay (min)
Measured: 6 hours
Time to recover the ability to walk
Duration for recovery the ability to walk (min)
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start3 Feb 2022
- Primary completion2 Feb 2023
- Study completion2 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Total Hip ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072704
- Sponsor's protocol ID
- 2021/04
- Acronym
- OFATHA
- Status last verified
- Apr 2026
- First submitted
- 17 Sep 2021
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38044236
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Free Anesthesia in Total Hip Arthroplasty. A Randomized, Controlled and Triple-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT05072704
- Acronym / sponsor ID
- OFATHA / 2021/04
- Conditions
- Primary Total Hip Arthroplasty
- Keywords
- Hip arthroplasty, Opioid free anesthesia, Dexmedetomidine, Postoperative analgesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the pre-anaesthesia room, after the implementation of classical monitoring and a peripheral venous catheter, all patients will receive an antibioprophylaxis according to SFAR (French Society of Anesthesia \& Intensive Care Medecine) recommendations and injection of 10 mg of IV dexamethasone.
The patients will be then randomized in 2 groups:
Control group:
- Pre-operative normal saline infusion 100 ml over 30 minutes
- Injection of sufentanil 10 µg in normal saline 2 ml on induction of anesthesia
If needed after incision :
- Per-operative normal saline infusion 100 ml
- Per-operative injection of sufentanil 5 µg in normal saline 1 ml
OFA group (experimental group):
- Pre-operative dexmedetomidine infusion 1 µg/kg in normal saline 100 ml over 30 minutes
- Injection of normal saline 2 ml on induction of anesthesia
If needed after incision :
- Per-operative dexmedetomidine infusion 0.4 µg/kg in normal saline 100 ml
- Per-operative injection of normal saline 1 ml
In the operating room, general anesthesia will be induced by intravenous ketamine (0.4 mg/kg) + propofol (3 mg/kg) +/- cisatracurium (0.1 mg/kg) for the introduction of laryngeal mask airway. Anesthesia will be maintained with propofol.
Postoperative analgesia protocol :
- Multimodal analgesia will be instituted during surgery by the administration of paracetamol (1 g), nefopam (20 mg) and ketoprofen (100 mg) and the infiltration of the surgical wound with 100 ml of ropivacaine 0.2%.
- In post-anesthesia care unit (PACU): oxycodone titration if NRS (pain score) >3 according to the centre's usual care.
- In ward and at home: systematic per os analgesia with paracetamol (1 g, 4 times a day) and ibuprofen (400 mg, 3 times a day); oxycodone (10 mg, lockout interval: 4 h) if NRS (pain score) >3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: SufentanilSufentanil IV injection |
| OFA group | Experimental | Drug: DexmedetomidineDexmedetomidine IV infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years and older,
- Undergoing outpatient primary total hip arthroplasty under general anesthesia with laryngeal mask,
- Consent for participation,
- Affiliation to a social security system
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SufentanilPre-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. | Drug | Control group |
| DexmedetomidinePre-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. | Drug | OFA group |
Primary outcome
Postoperative analgesia, defined by the oxycodone consumption in the first 24 hours post-surgery
Time frame: 24 hours
Postoperative cumulated dose of oxycodone in oral morphine equivalent (mg)
8 secondary outcomes
Analgesia in post-anesthesia care unit (PACU)
Time frame: 6 hours
Postoperative pain at rest
Time frame: 24 hours
Postoperative pain at walk
Time frame: 24 hours
Side effects associated with opioids
Time frame: 24 hours
Side effects associated with dexmedetomidine
Time frame: 24 hours
Outpatient care failure
Time frame: 24 hours
Length of stay in post-anesthesia care unit (PACU)
Time frame: 6 hours
Time to recover the ability to walk
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Results publication: PubMed 38044236Chassery 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sufentanil and Dexmedetomidine in people with Primary Total Hip Arthroplasty, run by CMC Ambroise Paré at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative analgesia, defined by the oxycodone consumption in the first 24 hours post-surgery (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05072704, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.