Intrathecal Morphine,Femoral Nerve Block,Periarticular Bupivacaine Infiltration for Pain After Intramedullary Hip Screw
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
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2010
1 active site
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
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 15, 2010
CompletedFirst Posted
Study publicly available on registry
October 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedAugust 4, 2011
August 1, 2011
2 years
September 15, 2010
August 3, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
The amount of morphine consumption.
24 hours postoperative
Secondary Outcomes (1)
Efficacy of pain control
48 hours postoperative
Study Arms (4)
Controlled group
NO INTERVENTIONSpinal anesthesia with 0.5% bupivacaine alone
Femoral nerve block
ACTIVE COMPARATORSpinal anesthesia plus femoral nerve block with 20 mL of 0.25% bupivacaine
Intrathecal morphine
ACTIVE COMPARATORSpinal anesthesia plus 0.1 mg of intrathecal morphine
Periarticular bupivacaine infiltration
ACTIVE COMPARATORSpinal anesthesia plus periarticular infiltration with 20 mL of 0.25% bupivacaine
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- previous history of hip surgery (the same side)
- pathological fractured such as severe infection, bone cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine Siriraj Hospital
Bangkok, 10700, Thailand
Related Publications (1)
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.
PMID: 33238043DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thitima Chinachoti, M.D.
Mahidol University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 15, 2010
First Posted
October 13, 2010
Study Start
September 1, 2010
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
August 4, 2011
Record last verified: 2011-08