Skip to content

Observational Prospective Study of Opiate-free Anesthesia for Anterior Total Hip Replacement

Observational Prospective Study of Opiate-free Anesthesia for Anterior Total Hip Replacement

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04112277
Acronym
ASOPHA
Enrollment
100
Registered
2019-10-02
Start date
2019-04-01
Completion date
2020-02-25
Last updated
2020-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Anesthesia, Rehabilitation

Brief summary

Opioid-free anesthesia (ATO) is a multimodal anaesthesia combining different analgesic and anesthetic modalities thus excluding opiates as an intraoperative. Recent studies have found a benefit from the ATO on postoperative rehabilitation and reduced length of hospitalization. Periarticular infiltration with a local anesthetic is one of the measures proposed in OFA during the PTH. PTH remains a painful procedure and the occurrence of morphinic-related side effects in sometimes elderly patients is often observed. The main objective of this study is to assess the feasibility of ATO in anterior hip replacement under general anesthesia with the primary endpoint of morphine consumption measured 24 hours after surgery.

Interventions

DRUGCumulative morphine consumption

morphine equivalent \[mg\] 24 hours after the procedure

Sponsors

Hôpital Privé Sévigné
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 18 and 85 * ASA (American Society of Anesthesiology) I-III * Total Hip Prosthesis programmed anteriorly * Prior obtaining free and informed written consent .Affiliation or beneficiary of a social security scheme. Patients affiliated with or beneficiaries of a social security plan and not included in another trial.

Exclusion criteria

* Pregnant women or breastfeeding Spinal anesthesia Patient on long-term opiate Body Mass Index (BMI) - 20 or 45kg/m2 Incomprehension of the ENS scale Unaccompanied cardiac conduction disorder, Adam-Stokes syndrome Preoperative Spontaneous Cardiac Frequency - 40 beats/min Left ventricle ejection fraction - 40% Unpaired sleep apnea syndrome (OSA) Adult incompetent, adults under guardianship or curatorial or deprived of liberty Allergy to one of the protocol products or their excipients: levobupivacaine, paracetamol, pregabalin, ketoprofen, dexmedetomidine Paracetamol-specific contraindication: hepatocellular deficiency Ketoprofen-specific contraindications: creatinine clearance - 60ml/min, ATCD of perforated peptic ulcer, heart failure, progressive hemorrhage, asthma associated with ketoprofen use Contraindications to nefopam: symptomatic prostate disorders, angle-closing glaucoma, epilepsy Participation in another clinical study

Design outcomes

Primary

MeasureTime frameDescription
Cumulative morphine consumption24 hours after the proceduremorphine equivalent \[mg\]

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026