NCT01947660

Brief Summary

This study aims to assess the safety of using continuous regional anesthesia for post-operative analgesia during septic limb orthopedic surgery. The study hypothesis is that continuous regional anesthesia would not induce septic complication in the operated limb and could improve post-operative recovery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2013

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

September 20, 2013

Status Verified

September 1, 2013

Enrollment Period

2.1 years

First QC Date

September 17, 2013

Last Update Submit

September 17, 2013

Conditions

Osteo ArthritisCellulitis

Outcome Measures

Primary Outcomes (1)

  • Septic complication in the operated limb

    Septic complication in the operated limb Pain score Nausea and vomiting

    28 days

Study Arms (2)

Continuous regional anesthesia

EXPERIMENTAL
Drug: Systemic analgesia + Continuous regional anesthesia

Systemic analgesia

ACTIVE COMPARATOR
Drug: Systemic analgesia

Interventions

Systemic analgesia + Continuous regional anesthesiaDRUG

Systemic analgesia + Continuous regional anesthesia, peri neural for the 2 to 4 first days post-operative

Continuous regional anesthesia
Systemic analgesiaDRUG

Systemic analgesia as usual

Systemic analgesia

Eligibility Criteria

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

You may qualify if:

  • Osteo arthritis or cellulitis requiring surgical intervention
  • anatomical possibility of regional anesthesia
  • age \>18 ans
  • written informed consent

You may not qualify if:

  • loco-regional anesthesia impossibility (puncture zone infection, local anesthesics allergie, amiodarone or mexilétine treatment, neurologic deficit for exemple)
  • patient under tutelle or curatelle
  • pregnant or beast feeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CCOM

Illkirch-Graffenstaden, Alsace, 67400, France

Location

MeSH Terms

Conditions

Cellulitis

Condition Hierarchy (Ancestors)

Skin Diseases, InfectiousInfectionsSuppurationConnective Tissue DiseasesSkin and Connective Tissue DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Pierre DIEMUNSCH, PU PH

CONTACT

03 88 12 70 76pierre.diemunsch@chru-strasbourg.fr

Eric NOLL, PH

CONTACT

03 88 55 23 37eric.noll@chru-strasbourg.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2013

First Posted

September 20, 2013

Study Start

October 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

September 20, 2013

Record last verified: 2013-09

Locations

FR(1)