NCT01378949

Brief Summary

A psoas compartment block has been used with good results for postoperative pain relief after total hip arthroplasty (THA). However, case reports describing serious complications after the use of this block, have been reported. The fascia iliaca compartment block (FICB) has been shown to be a reliable block for postoperative pain relief for procedures and injuries involving the hip. The investigators have not found any literature that has compared these two blocks. This study will compare the two blocks when used for post-operative pain relief after THA.

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
90

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable pain

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 23, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

June 23, 2011

Status Verified

June 1, 2011

Enrollment Period

2 years

First QC Date

June 19, 2011

Last Update Submit

June 22, 2011

Conditions

Keywords

pain score

Outcome Measures

Primary Outcomes (1)

  • Pain score of patients who have been given FICB for post-operative pain relief after THA

    3 days

Study Arms (3)

PsCB Group

ACTIVE COMPARATOR

Ultrasound-Guided Psoas Compartment Block will be used in patients for pain relief after THA

Drug: Bupivacaine

FICB Group

ACTIVE COMPARATOR

Ultrasound-Guided Fascia Iliaca Compartment Block will be used in patients for pain relief after THA

Drug: Bupivacaine

Patient-Controlled Analgesia

ACTIVE COMPARATOR

Patient-controlled analgesia will be used for pain relief after THA

Drug: Morphine

Interventions

Bupivacaine 0.5% with adrenaline 5 mcg/cc

FICB GroupPsCB Group

Morphine 1 mg/cc

Patient-Controlled Analgesia

Eligibility Criteria

Age45 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA Class I-III
  • Patients undergoing THA for osteoarthritis

You may not qualify if:

  • Skin infections adjacent to block site
  • Allergy to local analgesics
  • Patient unable to understand visual analogue scale (VAS)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Pain

Interventions

BupivacaineMorphine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 19, 2011

First Posted

June 23, 2011

Study Start

September 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

June 23, 2011

Record last verified: 2011-06

Locations