NCT02057601

Brief Summary

The purpose of this study is to determine that periarticular levobupivacaine infiltration after surgical fixation of fractured neck of femur will improve the early postoperative pain sensation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2014

Completed
Last Updated

February 7, 2014

Status Verified

February 1, 2014

Enrollment Period

5 months

First QC Date

February 5, 2014

Last Update Submit

February 5, 2014

Conditions

Fractured Neck of FemurPostoperative Pain

Keywords

Local anaesthetic infiltrationFractured neck of femurPostoperative pain

Outcome Measures

Primary Outcomes (1)

  • VRS pain score on passive movement 12 hours after the surgery

    We will assess the patients 12 hours after the surgical fixation of fractured neck of femur on passive movement (elevating the limb with 30 degree)

    12 hours after the surgery

Secondary Outcomes (1)

  • VRS pain scores in the first two postoperative day.

    48 hours

Other Outcomes (1)

  • Haemodynamic parameters

    48 hour

Study Arms (2)

Infiltration group

EXPERIMENTAL

The patients in this group will receive spinal anaesthesia with intrathecal bupivacaine 0.5% 2.0ml and will receive peri-surgical site infiltration before wound closure with a solution of levobupivacaine 0.5% 2mg/kg body weight with epinephrine made up to a volume of 1.5ml/kg with saline.

Drug: Levobupivacaine infiltration group

Non infiltration group

NO INTERVENTION

The patients in this group will receive spinal anaesthesia with intrathecal bupivacaine 0.5% 2.0 ml.

Interventions

Levobupivacaine infiltration groupDRUG

The patients in the intervention group will receive peri-surgical site infiltration before wound closure with a solution of levobupivacaine 0.5% 2mg/kg body weight with epinephrine made up to a volume of 1.5ml/kg with saline.

Infiltration group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients scheduled for surgical fixation of fractured neck of femur
  • consent to spinal anaesthesia
  • ASA grade 1-3

You may not qualify if:

  • Patients refusal
  • Mini mental scores less than 25
  • Allergy to bupivacaine, morphine, paracetamol and diclofenac
  • Skin lessons/ infections at the site of injection
  • Uncorrected renal dysfunction
  • Coagulation disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cork University Hospital

Cork, Cork, Ireland

Location

MeSH Terms

Conditions

Femoral Neck FracturesPain, Postoperative

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Lecturer in Anaesthesia

Study Record Dates

First Submitted

February 5, 2014

First Posted

February 7, 2014

Study Start

January 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

February 7, 2014

Record last verified: 2014-02

Locations

IE(1)