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Extra local pain relief in total hip replacement

Local Infiltration Anaesthesia in Total Hip Arthroplasty by Anterior Supine Intermuscular Approach - LIA in total hip arthroplasty

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-000989-37-NL
Enrollment
Unknown
Registered
2012-03-12
Start date
2012-06-01
Completion date
Unknown
Last updated
2015-12-07

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

Conditions

Local infiltration analgesia a multimodal pain management strategy in total hip arthroplasty. The Anterior Supine Intermuscular technique for THA procedures will allow the patient to mobilize much earlier postoperatively, however it has been hypothesized that it will give more pain direct postoperative. This study will investigate the effect of LIA in combination with the ASI technique.

Interventions

Trade Name: Ropivacaine HCl Fresenius Kabi Product Name: Ropivacaine Product Code: N01BB09 Pharmaceutical Form: Concentrate and solvent for solution for injection INN or Proposed INN: Ropivacain HCl C

Sponsors

Reinier de Graaf Groep
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • Patients aged 18 years and older. • Patients willing to participate. • ASA I and II. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70

Exclusion criteria

Exclusion criteria: • Patients unwilling to participate. • Mentally retarded. • Neurological conditions potentially influence pain perception. • Psychiatric conditions potentially influence pain perception. • ASA III, IV and V. • Cardiovascular impairment in the past. • Abuse of alcohol or drugs. • Known allergy for any element of the medication that is given. • Medical contra indication for spinal anaesthesia. • BMI > 40. • Rheumatoid arthritis.

Design outcomes

Primary

MeasureTime frame
Main Objective: Determining the outcome of reversed and antegrade LIA in THA with ASI by analysing postoperative pain with the 100 mm Visual Analogue Scale (VAS), length of hospital stay, the amount of postoperative consumption of opioid pain medication as well as the consumption of other pain medication;Secondary Objective: not applicable;Primary end point(s): - Pain score (VAS) at day 1 at multiple moments: 1, 4 and 8 hours after operation in rest, and while and direct after mobilization starting at 4-6 hours after operation. At day 2 until the day of discharge at two moments. - Cumulative consumption of opioid medication and pain medication. - Length of Hospital Stay by amount of nights and number of hours between operation and discharge. ;Timepoint(s) of evaluation of this end point: - VAS: 1,4,8 hours after operation in rest and direct after mobilization at 4-6 hours after operation. At day 2 until discharge at 2 standardized moments: morning and afternoon.

Secondary

MeasureTime frame
Secondary end point(s): not applicable

Countries

Netherlands

Contacts

Public ContactDepartment of orthopaedics

Reinier de Graaf Groep

N.Mathijssen@rdgg.nl0031152603718

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026