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Postoperative Analgesia for Fractured Neck of Femur With Periarticular Infiltration of Local Anaesthetic

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ClinicalTrials.gov Identifier: NCT02057601
Recruitment Status : Completed
First Posted : February 7, 2014
Last Update Posted : February 7, 2014
Sponsor:
Information provided by (Responsible Party):
Szilard Szucs, Cork University Hospital

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.

Condition or disease Intervention/treatment Phase
Fractured Neck of Femur Postoperative Pain Drug: Levobupivacaine infiltration group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Postoperative Analgesia Following Surgery for Fractured Neck of Femur: a Comparison of Periarticular Infiltration of Local Anaesthetic With Systemic Postoperative Analgesics
Study Start Date : January 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

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Arm Intervention/treatment
Experimental: Infiltration group
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
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.

No Intervention: Non infiltration group
The patients in this group will receive spinal anaesthesia with intrathecal bupivacaine 0.5% 2.0 ml.



Primary Outcome Measures :
  1. VRS pain score on passive movement 12 hours after the surgery [ Time Frame: 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)


Secondary Outcome Measures :
  1. VRS pain scores in the first two postoperative day. [ Time Frame: 48 hours ]
    After the operative fixation of fractured neck of femur, the patients will be assessed in the second, sixth, 12th, 24th and 48th postoperative hour. We will using VRS (0-10) pain scores at rest and passive movement.


Other Outcome Measures:
  1. Haemodynamic parameters [ Time Frame: 48 hour ]
    After surgical fixation of fractured neck of femur, the patients will be assessed in the second, sixth, 1 2nd, 24th and 48th hour. Blood pressure, heart rate, reap rate will be measured.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057601


Locations
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Ireland
Cork University Hospital
Cork, Ireland
Sponsors and Collaborators
Cork University Hospital
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Responsible Party: Szilard Szucs, Clinical Lecturer in Anaesthesia, Cork University Hospital
ClinicalTrials.gov Identifier: NCT02057601    
Other Study ID Numbers: ECM4 (zz) 09/04/13
ECM 4 (zz) 09/04/13 ( Other Identifier: Clinical Research Ethics Committee, Cork, Ireland )
First Posted: February 7, 2014    Key Record Dates
Last Update Posted: February 7, 2014
Last Verified: February 2014
Keywords provided by Szilard Szucs, Cork University Hospital:
Local anaesthetic infiltration
Fractured neck of femur
Postoperative pain
Additional relevant MeSH terms:
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Pain, Postoperative
Fractures, Bone
Femoral Neck Fractures
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Wounds and Injuries
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries
Levobupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents