Femoral Neck FracturePhase 4NCT01219062
Postoperative Pain Control After Hip Hemiarthroplasty: Intrathecal Morphine vs Periarticular Infiltration of Bupivacaine
A Phase 4 study testing morphine and Bupivacaine in people with Femoral Neck Fracture, run by Mahidol University at 2 sites in Thailand.
Trial summary
Falls are a common problem in elderly people which they have to receive the operation. Hemiarthroplasty is one of the common orthopedics operations. The prompt operation and good pain control will provide the good recovery and outcome. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Femoral Neck Fracture
- What is being tested?
- morphine and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesThailand
- Study dates
- Sep 2010to Apr 2011
- 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
- age between 18-90 years
- Co-operative, able to use PCA
- ASA classification 1-3
- no contraindication for Spinal Anesthesia
- patient acceptance for spinal anesthesia
- body weight > 30 kg.
- BMI between 20-35
- no history of drug allergy, e.g. Local Anesthetics, Paracetamol, etc.
Who cannot join
- age > 90 years
- previous Hemiarthroplasty (the same site)
- pathological fracture such as severe infection, bone cancer
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Faculty of Medicine Siriraj Hospital
Bangkok, 10700
Thitima Chinachot
Bangkok, 10700
About this study
Official title: Comparative of Postoperative Pain Control at 24 and 48 Hours Between Intrathecal 0.1 mg. of Morphine or Local Infiltration of 20 ml. of 0.25% Bupivacaine in Patients Post Hip Hemiarthroplasty Under Spinal Anesthesis
Falls are a common problem in elderly people which they have to receive the operation. Hemiarthroplasty is one of the common orthopedics operations. The prompt operation and good pain control will provide the good recovery and outcome. The investigators compare the efficacy of postoperative pain control between Intrathecal morphine 0.1 milligrams (mg.) with the local infiltration of 0.25% Bupivacaine for 20 milliliters (ml.) in patients received hip hemiarthroplasty under spinal anesthesia.
Read the detailed description
Study process All the patients who assigned the hip hemiarthroplasty without any exclusion criteria will be enrolled in the study and be divided into 3 groups randomly
- control group : the patients will be received spinal anesthesia with 0.5% Isobaric Bupivacaine and postoperative pain control by intravenous (IV) Patient - control Analgesia (PCA)
- Morphine group : the patients will be received 0.1 mg. of Morphine added in Isobaric Bupivacaine for spinal anesthesia and postoperative pain control by IV PCA
- Local group : the patients will be received spinal anesthesia and periarticular tissue infiltration with 0.25% Bupivacaine and postoperative pain control by IV PCA
Data collection
- Demographic data : age, sex, Body Weight, Body Mass Index (BMI), ...
- Pain score every 3 hours postoperatively in the first 6 hours and at the 12th hours by visual analogue scoring system
- Patient global assessment and patient satisfactory visual analogue scoring system at 24th and 48th hour
- the amount of morphine during 24 and 48 hours postoperative and the time of first dose they received
- Conditions
- Femoral Neck Fracture
- Being tested
- morphine, control, Bupivacaine
- 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.
morphineDrug
periarticular infiltration with 0.25% Bupivacaine for 20 ml.
controlOther
the patients will be received spinal anesthesia with 0.5% Isobaric Bupivacaine and postoperative pain control by intravenous (IV) Patient - control Analgesia (PCA)
BupivacaineDrug
the patients will be received spinal anesthesia and periarticular tissue infiltration with 0.25% Bupivacaine and postoperative pain control by IV PCA
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | The patient will be performed spinal anesthesia alone, with postoperative PCA Receives: Other: control |
| Morphine | Active comparator | The patient will received intrathecal Morphine for 0.1 mg. in Isobaric bupivacaine in spinal anesthesia and postoperative PCA Receives: Drug: morphine |
| bupivacaine | Active comparator | the patients will be received spinal anesthesia and periarticular tissue infiltration with 0.25% Bupivacaine and postoperative pain control by IV PCA Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Amount of Morphine consumption after Hemiarthroplasty
Measured: 24 hours
Secondary outcomes (1)
Efficacy of pain control
Efficacy of pain control measured by
- the amount of morphine which the patient needed to keep pain score 2-3
- patient global assessment
- patient satisfaction assessed by visual analogue scale
- incidence of adverse effect such as pruritus, nausea and vomiting,...
Measured: 48 hours
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 completionApr 2011
- Study completionApr 2011
Why it stopped: Surgeon team were not happy with the study protocol, the periarticular injection of local anesthetics
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FractureStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aphichat Suphathamwit,, Mahidol University
- Investigators
- Thitima Chinachoti, MD, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219062
- Sponsor's protocol ID
- Si391/2010
- Status last verified
- Oct 2016
- First submitted
- 15 Sep 2010
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative of Postoperative Pain Control at 24 and 48 Hours Between Intrathecal 0.1 mg. of Morphine or Local Infiltration of 20 ml. of 0.25% Bupivacaine in Patients Post Hip Hemiarthroplasty Under Spinal Anesthesis
- ClinicalTrials.gov ID
- NCT01219062
- Acronym / sponsor ID
- Si391/2010
- Conditions
- Femoral Neck Fracture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Surgeon team were not happy with the study protocol, the periarticular injection of local anesthetics
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- 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 people which they have to receive the operation. Hemiarthroplasty is one of the common orthopedics operations. The prompt operation and good pain control will provide the good recovery and outcome. The investigators compare the efficacy of postoperative pain control between Intrathecal morphine 0.1 milligrams (mg.) with the local infiltration of 0.25% Bupivacaine for 20 milliliters (ml.) in patients received hip hemiarthroplasty under spinal anesthesia.
Detailed description
Study process All the patients who assigned the hip hemiarthroplasty without any exclusion criteria will be enrolled in the study and be divided into 3 groups randomly
- control group : the patients will be received spinal anesthesia with 0.5% Isobaric Bupivacaine and postoperative pain control by intravenous (IV) Patient - control Analgesia (PCA)
- Morphine group : the patients will be received 0.1 mg. of Morphine added in Isobaric Bupivacaine for spinal anesthesia and postoperative pain control by IV PCA
- Local group : the patients will be received spinal anesthesia and periarticular tissue infiltration with 0.25% Bupivacaine and postoperative pain control by IV PCA
Data collection
- Demographic data : age, sex, Body Weight, Body Mass Index (BMI), ...
- Pain score every 3 hours postoperatively in the first 6 hours and at the 12th hours by visual analogue scoring system
- Patient global assessment and patient satisfactory visual analogue scoring system at 24th and 48th hour
- the amount of morphine during 24 and 48 hours postoperative and the time of first dose they received
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Other: controlThe patient will be performed spinal anesthesia alone, with postoperative PCA |
| Morphine | Active comparator | Drug: morphineThe patient will received intrathecal Morphine for 0.1 mg. in Isobaric bupivacaine in spinal anesthesia and postoperative PCA |
| bupivacaine | Active comparator | Drug: Bupivacainethe patients will be received spinal anesthesia and periarticular tissue infiltration with 0.25% Bupivacaine and postoperative pain control by IV PCA |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age between 18-90 years
- Co-operative, able to use PCA
- ASA classification 1-3
- no contraindication for Spinal Anesthesia
- patient acceptance for spinal anesthesia
Key exclusion criteria (3 listed)
- age > 90 years
- previous Hemiarthroplasty (the same site)
- pathological fracture 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 |
|---|---|---|
| morphineperiarticular infiltration with 0.25% Bupivacaine for 20 ml. | Drug | Morphine |
| controlthe patients will be received spinal anesthesia with 0.5% Isobaric Bupivacaine and postoperative pain control by intravenous (IV) Patient - control Analgesia (PCA) | Other | control |
| Bupivacainethe patients will be received spinal anesthesia and periarticular tissue infiltration with 0.25% Bupivacaine and postoperative pain control by IV PCA | Drug | bupivacaine |
Primary outcome
The Amount of Morphine consumption after Hemiarthroplasty
Time frame: 24 hours
1 secondary outcome
Efficacy of pain control
Time frame: 48 hours
Results and safety
The study was stopped early (reason given: Surgeon team were not happy with the study protocol, the periarticular injection of local anesthetics). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
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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, MD principal investigator
Siriraj Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing morphine and Bupivacaine in people with Femoral Neck Fracture, run by Mahidol University at 2 sites 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 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: stopped early, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: Surgeon team were not happy with the study protocol, the periarticular injection of local anesthetics). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Amount of Morphine consumption after Hemiarthroplasty (time frame: 24 hours). 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 4 Oct 2016.