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Intrathecal Morphine,Femoral Nerve Block,Periarticular Bupivacaine Infiltration for Pain After Intramedullary Hip Screw

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ClinicalTrials.gov Identifier: NCT01219088
Recruitment Status : Unknown
Verified August 2011 by Mahidol University.
Recruitment status was:  Recruiting
First Posted : October 13, 2010
Last Update Posted : August 4, 2011
Sponsor:
Information provided by:
Mahidol University

Brief Summary:
Falls are a common problem in elderly patients resulting fractured femur, which require early operation. Adequate postoperative pain control will provide good recovery. The investigators will compare the efficacy of postoperative pain control among intrathecal morphine, femoral nerve block, and periarticular infiltration with bupivacaine in patients undergone intramedullary hip screw under spinal anesthesia.

Condition or disease Intervention/treatment Phase
Femoral Neck Fractures Drug: Bupivacaine, morphine Phase 4

Detailed Description:

Study methods :

Every patients without any exclusion criteria will be performed spinal anesthesia by 0.5% heavy bupivacaine then divided into 4 groups

  1. Controlled group : spinal anesthesia alone
  2. Femoral nerve block by 20 mL of 0.25% bupivacaine before spinal anesthesia
  3. Spinal anesthesia plus 0.1 mg morphine intrathecally
  4. Spinal anesthesia plus periarticular infiltration with 20 mL of 0.25% bupivacaine

All patients will receive postoperative intravenous patient controlled analgesia (IV PCA) morphine for 48 hours.

Data collection

  1. Demographic data
  2. Pain score : preoperative, 3 hours postoperative in the 1st six hours, 12 hours postoperative by visual analog scoring system (VASS)
  3. Patient global assessment and patient satisfactory VASS at 24 and 48 hours postoperative
  4. The amount of morphine at 24 and 48 hours postoperative and the time of the 1st dose

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Post Operative Pain Control Among Intrathecal 0.1 mg Morphine, Femoral Nerve Block, or Periarticular Infiltration of 20 mL of 0.25% Bupivacaine in Patients Post Intramedullary Hip Screw
Study Start Date : September 2010
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Controlled group
Spinal anesthesia with 0.5% bupivacaine alone
Drug: Bupivacaine, morphine
1.8-2.5 mL of 0.5% heavy bupivacaine for spinal anesthesia 20 mL of 0.25% bupivacaine for femoral nerve block 0.1 mg of intrathecal morphine 20 mL of 0.25% bupivacaine for periarticular infiltration

Active Comparator: Femoral nerve block
Spinal anesthesia plus femoral nerve block with 20 mL of 0.25% bupivacaine
Drug: Bupivacaine, morphine
1.8-2.5 mL of 0.5% heavy bupivacaine for spinal anesthesia 20 mL of 0.25% bupivacaine for femoral nerve block 0.1 mg of intrathecal morphine 20 mL of 0.25% bupivacaine for periarticular infiltration

Active Comparator: Intrathecal morphine
Spinal anesthesia plus 0.1 mg of intrathecal morphine
Drug: Bupivacaine, morphine
1.8-2.5 mL of 0.5% heavy bupivacaine for spinal anesthesia 20 mL of 0.25% bupivacaine for femoral nerve block 0.1 mg of intrathecal morphine 20 mL of 0.25% bupivacaine for periarticular infiltration

Active Comparator: Periarticular bupivacaine infiltration
Spinal anesthesia plus periarticular infiltration with 20 mL of 0.25% bupivacaine
Drug: Bupivacaine, morphine
1.8-2.5 mL of 0.5% heavy bupivacaine for spinal anesthesia 20 mL of 0.25% bupivacaine for femoral nerve block 0.1 mg of intrathecal morphine 20 mL of 0.25% bupivacaine for periarticular infiltration




Primary Outcome Measures :
  1. The amount of morphine consumption. [ Time Frame: 24 hours postoperative ]

Secondary Outcome Measures :
  1. Efficacy of pain control [ Time Frame: 48 hours postoperative ]

    Efficacy of pain control measured by

    1. The amout of morphine consumption
    2. Visual analogue pain scale
    3. Patient satisfaction by patient global assessment
    4. Incidences of adverse events : nausea, vomiting, pruritus



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-90 years old
  • good consciousness, well co-operated, can use PCA machine
  • ASA class 1-3
  • no contraindication of spinal anesthesia
  • accept for spinal anesthesia
  • body weight > 30 kg
  • BMI 20-35 kg/m2
  • no history of research-drug allergy

Exclusion Criteria:

  • previous history of hip surgery (the same side)
  • pathological fractured such as severe infection, bone cancer

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): NCT01219088


Contacts
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Contact: Thitima Chinachoti, M.D. 66813082438 sitci35@gmail.com
Contact: Sathit Chairatthanawanit, M.D. 66817902397 sathit13@hotmail.com

Locations
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Thailand
Faculty of Medicine Siriraj Hospital Recruiting
Bangkok, Thailand, 10700
Contact: Thitima Chinachoti, MD    6681-3082438    sitci35@gmail.com   
Principal Investigator: Thitima Chinachoti, MD         
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Thitima Chinachoti, M.D. Mahidol University

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Responsible Party: Assoc. Prof. Thitima Chinachoti, M.D., Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University
ClinicalTrials.gov Identifier: NCT01219088    
Other Study ID Numbers: Si392/2010
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: August 4, 2011
Last Verified: August 2011
Additional relevant MeSH terms:
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Femoral Neck Fractures
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Morphine
Bupivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics