NCT01219088

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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2010

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

August 4, 2011

Status Verified

August 1, 2011

Enrollment Period

2 years

First QC Date

September 15, 2010

Last Update Submit

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 INTERVENTION

Spinal anesthesia with 0.5% bupivacaine alone

Drug: Bupivacaine, morphine

Femoral nerve block

ACTIVE COMPARATOR

Spinal anesthesia plus femoral nerve block with 20 mL of 0.25% bupivacaine

Drug: Bupivacaine, morphine

Intrathecal morphine

ACTIVE COMPARATOR

Spinal anesthesia plus 0.1 mg of intrathecal morphine

Drug: Bupivacaine, morphine

Periarticular bupivacaine infiltration

ACTIVE COMPARATOR

Spinal anesthesia plus periarticular infiltration with 20 mL of 0.25% bupivacaine

Drug: Bupivacaine, morphine

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

Controlled groupFemoral nerve blockIntrathecal morphinePeriarticular bupivacaine infiltration

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

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.

MeSH Terms

Conditions

Femoral Neck Fractures

Interventions

BupivacaineMorphine

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Thitima Chinachoti, M.D.

    Mahidol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thitima Chinachoti, M.D.

CONTACT

Sathit Chairatthanawanit, M.D.

CONTACT

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

Locations