Femoral Neck FracturesPhase 4NCT01219088
Intrathecal Morphine,Femoral Nerve Block,Periarticular Bupivacaine Infiltration for Pain After Intramedullary Hip Screw
A Phase 4 study testing Bupivacaine, morphine in people with Femoral Neck Fractures, run by Mahidol University at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- Bupivacaine, morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2010to Sep 2012
- Phase
- Phase 4
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- previous history of hip surgery (the same side)
- pathological fractured such as severe infection, bone cancer
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital
Bangkok, 10700
Thitima Chinachoti, MD, 6681-3082438, sitci35@gmail.com
Thitima Chinachoti, MD
About this study
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
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.
Read the 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
- Conditions
- Femoral Neck Fractures
- Being tested
- Bupivacaine, morphine
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine, morphineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Controlled group | No intervention | Spinal anesthesia with 0.5% bupivacaine alone Receives: Drug: Bupivacaine, morphine |
| Femoral nerve block | Active comparator | Spinal anesthesia plus femoral nerve block with 20 mL of 0.25% bupivacaine Receives: Drug: Bupivacaine, morphine |
| Intrathecal morphine | Active comparator | Spinal anesthesia plus 0.1 mg of intrathecal morphine Receives: Drug: Bupivacaine, morphine |
| Periarticular bupivacaine infiltration | Active comparator | Spinal anesthesia plus periarticular infiltration with 20 mL of 0.25% bupivacaine Receives: Drug: Bupivacaine, morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of morphine consumption.
Measured: 24 hours postoperative
Secondary outcomes (1)
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
Measured: 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Investigators
- Thitima Chinachoti, M.D., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219088
- Sponsor's protocol ID
- Si392/2010
- Status last verified
- Aug 2011
- First submitted
- 15 Sep 2010
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33238043
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01219088
- Acronym / sponsor ID
- Si392/2010
- Conditions
- Femoral Neck Fractures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 13 Oct 2010 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Controlled group | No intervention | Drug: Bupivacaine, morphineSpinal anesthesia with 0.5% bupivacaine alone |
| Femoral nerve block | Active comparator | Drug: Bupivacaine, morphineSpinal anesthesia plus femoral nerve block with 20 mL of 0.25% bupivacaine |
| Intrathecal morphine | Active comparator | Drug: Bupivacaine, morphineSpinal anesthesia plus 0.1 mg of intrathecal morphine |
| Periarticular bupivacaine infiltration | Active comparator | Drug: Bupivacaine, morphineSpinal anesthesia plus periarticular infiltration with 20 mL of 0.25% bupivacaine |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- previous history of hip surgery (the same side)
- pathological fractured such as severe infection, bone cancer
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 |
|---|---|---|
| Bupivacaine, morphine1.8-2.5 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 | Drug | Controlled group, Femoral nerve block, Intrathecal morphine, Periarticular bupivacaine infiltration |
Primary outcome
The amount of morphine consumption.
Time frame: 24 hours postoperative
1 secondary outcome
Efficacy of pain control
Time frame: 48 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2011.
- Derived from this study: PubMed 33238043Guay 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.
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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.
Thitima Chinachoti, M.D. principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine, morphine in people with Femoral Neck Fractures, run by Mahidol University at 1 site in Thailand.
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 8 inclusion and 2 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 4 Aug 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 Thailand. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Thitima Chinachoti, M.D. (66813082438, sitci35@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of morphine consumption. (time frame: 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01219088, which also lists 1 linked publication.
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 4 Aug 2011.