PainNCT01378949
Psoas Compartment Block Versus Fascia Iliaca Block After Total Hip Arthroplasty
A study testing Bupivacaine and Morphine in people with Pain, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Pain
- What is being tested?
- Bupivacaine and Morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2011to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA Class I-III
- Patients undergoing THA for osteoarthritis
Who cannot join
- Skin infections adjacent to block site
- Allergy to local analgesics
- Patient unable to understand visual analogue scale (VAS)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pain
- Being tested
- Bupivacaine, Morphine
- Keywords
- pain score
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Bupivacaine 0.5% with adrenaline 5 mcg/cc
MorphineDrug
Morphine 1 mg/cc
| Study group | Role | What they receive |
|---|---|---|
| PsCB Group | Active comparator | Ultrasound-Guided Psoas Compartment Block will be used in patients for pain relief after THA Receives: Drug: Bupivacaine |
| FICB Group | Active comparator | Ultrasound-Guided Fascia Iliaca Compartment Block will be used in patients for pain relief after THA Receives: Drug: Bupivacaine |
| Patient-Controlled Analgesia | Active comparator | Patient-controlled analgesia will be used for pain relief after THA Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score of patients who have been given FICB for post-operative pain relief after THA
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378949
- Sponsor's protocol ID
- 2259-11-HYMC
- Status last verified
- Jun 2011
- First submitted
- 19 Jun 2011
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psoas Compartment Block Versus Fascia Iliaca Block After Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT01378949
- Acronym / sponsor ID
- 2259-11-HYMC
- Conditions
- Pain
- Keywords
- pain score
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Sep 2011
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 23 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PsCB Group | Active comparator | Drug: BupivacaineUltrasound-Guided Psoas Compartment Block will be used in patients for pain relief after THA |
| FICB Group | Active comparator | Drug: BupivacaineUltrasound-Guided Fascia Iliaca Compartment Block will be used in patients for pain relief after THA |
| Patient-Controlled Analgesia | Active comparator | Drug: MorphinePatient-controlled analgesia will be used for pain relief after THA |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA Class I-III
- Patients undergoing THA for osteoarthritis
Key exclusion criteria (3 listed)
- Skin infections adjacent to block site
- Allergy to local analgesics
- Patient unable to understand visual analogue scale (VAS)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupivacaineBupivacaine 0.5% with adrenaline 5 mcg/cc | Drug | FICB Group, PsCB Group |
| MorphineMorphine 1 mg/cc | Drug | Patient-Controlled Analgesia |
Primary outcome
Pain score of patients who have been given FICB for post-operative pain relief after THA
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine and Morphine in people with Pain, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anatoly Stav, MD (972-4-630-4529, stav@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score of patients who have been given FICB for post-operative pain relief after THA (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.