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Local infiltration with anesthetics vs placebo in patients with elective total hip replacement (thr) in fast-track protocol

Local infiltration with anesthetics vs placebo in patients with elective total hip replacement (thr) in fast-track protocol - nvt

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41707
Enrollment
160
Registered
2014-01-14
Start date
2014-07-21
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

new hip pain management

Interventions

In our study, the post-operative pain in patients who have undergone a THP examined. The subjects are divided into two groups. Patients in Group 1 get an infiltration with ropivacaine pre-operativel

Sponsors

Spaarne Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -in writing given informed consent ;-over 18 years of age ;- operation indication: primary coxarthrosis ;-Dutch speaking and understanding ;-Spinal anaesthesia ;-patients who go home after surgery (secondary outcome length of stay)

Exclusion criteria

Exclusion criteria: -Patients who within 12 months prior to the surgery were opioid-dependent. ;-malignancies. ;-Patients with co-morbidities which may affect the possible pain perception (in the prehistory: CVA or a psychiatric disorder). ;-Patients with allergies to ropivacaine ;-ASA 3-4 ;-Patients with a peroperatieve complication occurs which interferes with the normal mobilization and pain experience (fractures, vascular/nerve injury

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the NRS pain score 24 hours postoperatively at rest

Secondary

MeasureTime frame
Secondary endpoints are the-NRS scores for pain (from 24 hours) to 48 hours postoperatively -HOOS (pre OK and 6 WKS post) -SF12 (pre OK and 6 WKS post) -Oxford Hip score (pre OK and 6 WKS post) -length of stay -Presence of nausea, vomiting, bladder retention -Complications -Use analgesics: PCA-use/opiates - NRS pain during rest and mobilization till 48 hours postoepratively

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)