Intrathecal Morphine,Femoral Nerve Block,Periarticular Bupivacaine Infiltration for Pain After Intramedullary Hip Screw
Primary Purpose
Femoral Neck Fractures
Status
Unknown status
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Bupivacaine, morphine
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Neck Fractures
Eligibility 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
Sites / Locations
- Faculty of Medicine Siriraj HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Active Comparator
Active Comparator
Active Comparator
Arm Label
Controlled group
Femoral nerve block
Intrathecal morphine
Periarticular bupivacaine infiltration
Arm Description
Spinal anesthesia with 0.5% bupivacaine alone
Spinal anesthesia plus femoral nerve block with 20 mL of 0.25% bupivacaine
Spinal anesthesia plus 0.1 mg of intrathecal morphine
Spinal anesthesia plus periarticular infiltration with 20 mL of 0.25% bupivacaine
Outcomes
Primary Outcome Measures
The amount of morphine consumption.
Secondary Outcome Measures
Efficacy of pain control
Efficacy of pain control measured by
The amout of morphine consumption
Visual analogue pain scale
Patient satisfaction by patient global assessment
Incidences of adverse events : nausea, vomiting, pruritus
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01219088
Brief Title
Intrathecal Morphine,Femoral Nerve Block,Periarticular Bupivacaine Infiltration for Pain After Intramedullary Hip Screw
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 Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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
Controlled group : spinal anesthesia alone
Femoral nerve block by 20 mL of 0.25% bupivacaine before spinal anesthesia
Spinal anesthesia plus 0.1 mg morphine intrathecally
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
Demographic data
Pain score : preoperative, 3 hours postoperative in the 1st six hours, 12 hours postoperative by visual analog scoring system (VASS)
Patient global assessment and patient satisfactory VASS at 24 and 48 hours postoperative
The amount of morphine at 24 and 48 hours postoperative and the time of the 1st dose
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Controlled group
Arm Type
No Intervention
Arm Description
Spinal anesthesia with 0.5% bupivacaine alone
Arm Title
Femoral nerve block
Arm Type
Active Comparator
Arm Description
Spinal anesthesia plus femoral nerve block with 20 mL of 0.25% bupivacaine
Arm Title
Intrathecal morphine
Arm Type
Active Comparator
Arm Description
Spinal anesthesia plus 0.1 mg of intrathecal morphine
Arm Title
Periarticular bupivacaine infiltration
Arm Type
Active Comparator
Arm Description
Spinal anesthesia plus periarticular infiltration with 20 mL of 0.25% bupivacaine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine, morphine
Intervention Description
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 Measure Information:
Title
The amount of morphine consumption.
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
Efficacy of pain control
Description
Efficacy of pain control measured by
The amout of morphine consumption
Visual analogue pain scale
Patient satisfaction by patient global assessment
Incidences of adverse events : nausea, vomiting, pruritus
Time Frame
48 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thitima Chinachoti, M.D.
Phone
66813082438
Email
sitci35@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sathit Chairatthanawanit, M.D.
Phone
66817902397
Email
sathit13@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thitima Chinachoti, M.D.
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thitima Chinachoti, MD
Phone
6681-3082438
Email
sitci35@gmail.com
First Name & Middle Initial & Last Name & Degree
Thitima Chinachoti, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
33238043
Citation
Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.
Results Reference
derived
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Intrathecal Morphine,Femoral Nerve Block,Periarticular Bupivacaine Infiltration for Pain After Intramedullary Hip Screw
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