Fracture of Proximal FemurNCT02801188
Effect of Dexmedetomidine and Bupivacaine for Paravertebral Block
A study testing Bupivacaine and Mixture of bupivacaine and dexmedetomidine in people with Fracture of Proximal Femur, run by Mansoura University at 1 site in Egypt.
Trial summary
Fracture femur is a common that results in severe pain. Many methods of regional and peripheral analgesia have been described to treat such pain. In this study the investigators consider using paravertebral block to treat post-fracture pain. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Fracture of Proximal Femur
- What is being tested?
- Bupivacaine and Mixture of bupivacaine and dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2014to 1 Dec 2015
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical class I or II
Who cannot join
- Patient refusal.
- Severe or uncompensated cardiovascular disease.
- Severe or uncompensated renal disease.
- Severe or uncompensated hepatic disease.
- Severe or uncompensated endocrinal disease.
- Pregnancy.
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- Postpartum ladies.
- Lactating females.
- Allergy to any of the study medications .
- Coagulation disorders.
- Infection at the site of needle insertion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Effect of Adding Dexmedetomidine to Bupivacaine for Paravertebral Block in Femoral Fractures
Fracture femur is a common that results in severe pain. Many methods of regional and peripheral analgesia have been described to treat such pain. In this study the investigators consider using paravertebral block to treat post-fracture pain. Additionally, they consider adding dexmedetomidine to the used local anesthetic solution to prolong the duration of this block and hence postoperative analgesia.
Read the detailed description
Fracture femur is a common injury which is associated with excruciating pain . This pain is one of the most important causes of postoperative morbidity and mortality when it is insufficiently treated pain. Pain induces neuroendocrine stress response causing problems like as reduction in vital capacity, pneumonia, tachycardia, hypertension, myocardial ischemia and even infarction. These problems can be prevented by successful management of postoperative pain.
In patients with proximal femoral fracture, the use of paravertebral blockade produces reliable level of analgesia without need for additional nursing skills or monitoring in the postoperative period. Paravertebral blockade by injection local anesthetic solution alongside the vertebral column produces ipsilateral analgesia.
Currently available local anesthetics as bupivacaine may not provide reliable periods of analgesia resulting in block resolution before the period of worst postoperative pain. The use of a large volume of local anesthetic is one of methods to overcome this problem that may lengthen the duration of analgesia but at increased risk of local anesthetic toxicity. Adding adjuvants is another potential alternative.
Dexmedetomidine, a selective α 2 agonist, has been used to prolong the duration of analgesia of nerve blocks. Dexmedetomidine has also been reported to enhance central and peripheral nerve blockade. Alpha adrenoceptors located at the nerve endings have a possible role in the analgesic mechanisms by preventing norepinephrine release. The spinal mechanism is the principle mechanism for the analgesic action of dexmedetomidine.
- Conditions
- Fracture of Proximal Femur
- Being tested
- Bupivacaine, Mixture of bupivacaine and dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5% and water soluble radio-opaque dye.
Mixture of bupivacaine and dexmedetomidineDrug
Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5%, water soluble radio-opaque dye, and1 ug/kg of dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine group | Placebo comparator | Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5% and water soluble radio-opaque dye. Receives: Drug: Bupivacaine |
| Mixture of bupivacaine and dexmedetomidine group | Active comparator | Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5%, water soluble radio-opaque dye and 1 ug/kg of dexmedetomidine Receives: Drug: Mixture of bupivacaine and dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale for radiological spread of the injectate
It will be assessed using the following scale -2; spread for two vertebral levels below the site of injection, -1; spread for one vertebral level below the site of injection, 0; stays at the level of injection, +2; spread for two vertebral levels above the site of injection, +1; spread for one vertebral level above the site of injection
Measured: for 20 min after performing the blockade
Secondary outcomes (3)
Pain scores
The severity of pain will be assessed using a visual analog scale (VAS)
Measured: For 48 hours after surgery
Duration of postoperative analgesia
The period from completion of the block to time of administration of the first request of rescue analgesic for postoperative pain will be recorded
Measured: for 24 hours after surgery
Postoperative analgesic consumption
Total postoperative analgesic consumption
Measured: for 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start1 Oct 2014
- Primary completion1 Oct 2015
- Study completion1 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of Proximal FemurStudies of the same condition, open and under way.
- More trials run by Mansoura 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reem A El sharkawy, MD, Principal investigator, Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, EgyptMohamed Y Makharita, MD, Study director, Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, EgyptNabil Abd-El Raouf, MD, Study chair, Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801188
- Sponsor's protocol ID
- MD ∕ 128
- Status last verified
- Sep 2020
- First submitted
- 22 Apr 2016
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Effect of Adding Dexmedetomidine to Bupivacaine for Paravertebral Block in Femoral Fractures
- ClinicalTrials.gov ID
- NCT02801188
- Acronym / sponsor ID
- MD ∕ 128
- Conditions
- Fracture of Proximal Femur
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 1 Oct 2015 (actual)
- Study completion
- 1 Dec 2015 (actual)
- First posted
- 15 Jun 2016 (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.
Fracture femur is a common that results in severe pain. Many methods of regional and peripheral analgesia have been described to treat such pain. In this study the investigators consider using paravertebral block to treat post-fracture pain. Additionally, they consider adding dexmedetomidine to the used local anesthetic solution to prolong the duration of this block and hence postoperative analgesia.
Detailed description
Fracture femur is a common injury which is associated with excruciating pain . This pain is one of the most important causes of postoperative morbidity and mortality when it is insufficiently treated pain. Pain induces neuroendocrine stress response causing problems like as reduction in vital capacity, pneumonia, tachycardia, hypertension, myocardial ischemia and even infarction. These problems can be prevented by successful management of postoperative pain.
In patients with proximal femoral fracture, the use of paravertebral blockade produces reliable level of analgesia without need for additional nursing skills or monitoring in the postoperative period. Paravertebral blockade by injection local anesthetic solution alongside the vertebral column produces ipsilateral analgesia.
Currently available local anesthetics as bupivacaine may not provide reliable periods of analgesia resulting in block resolution before the period of worst postoperative pain. The use of a large volume of local anesthetic is one of methods to overcome this problem that may lengthen the duration of analgesia but at increased risk of local anesthetic toxicity. Adding adjuvants is another potential alternative.
Dexmedetomidine, a selective α 2 agonist, has been used to prolong the duration of analgesia of nerve blocks. Dexmedetomidine has also been reported to enhance central and peripheral nerve blockade. Alpha adrenoceptors located at the nerve endings have a possible role in the analgesic mechanisms by preventing norepinephrine release. The spinal mechanism is the principle mechanism for the analgesic action of dexmedetomidine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine group | Placebo comparator | Drug: BupivacaineParavertebral blockade will be performed using combined mixture of bupivacaine 0.5% and water soluble radio-opaque dye. |
| Mixture of bupivacaine and dexmedetomidine group | Active comparator | Drug: Mixture of bupivacaine and dexmedetomidineParavertebral blockade will be performed using combined mixture of bupivacaine 0.5%, water soluble radio-opaque dye and 1 ug/kg of dexmedetomidine |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists physical class I or II
Key exclusion criteria (11 listed)
- Patient refusal.
- Severe or uncompensated cardiovascular disease.
- Severe or uncompensated renal disease.
- Severe or uncompensated hepatic disease.
- Severe or uncompensated endocrinal disease.
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 |
|---|---|---|
| BupivacaineParavertebral blockade will be performed using combined mixture of bupivacaine 0.5% and water soluble radio-opaque dye. | Drug | Bupivacaine group |
| Mixture of bupivacaine and dexmedetomidineParavertebral blockade will be performed using combined mixture of bupivacaine 0.5%, water soluble radio-opaque dye, and1 ug/kg of dexmedetomidine | Drug | Mixture of bupivacaine and dexmedetomidine group |
Primary outcome
Scale for radiological spread of the injectate
Time frame: for 20 min after performing the blockade
It will be assessed using the following scale -2; spread for two vertebral levels below the site of injection, -1; spread for one vertebral level below the site of injection, 0; stays at the level of injection, +2; spread for two vertebral levels above the site of injection, +1; spread for one vertebral level above the site of injection
3 secondary outcomes
Pain scores
Time frame: For 48 hours after surgery
Duration of postoperative analgesia
Time frame: for 24 hours after surgery
Postoperative analgesic consumption
Time frame: for 48 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Reem A El sharkawy, MD principal investigator
Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
Mohamed Y Makharita, MD study director
Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
Nabil Abd-El Raouf, MD study chair
Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
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 Mixture of bupivacaine and dexmedetomidine in people with Fracture of Proximal Femur, run by Mansoura University at 1 site in Egypt.
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 1 inclusion and 11 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: finished, as of the sponsor's last update on 22 Sep 2020. 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 Egypt. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Scale for radiological spread of the injectate (time frame: for 20 min after performing the blockade). 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 22 Sep 2020.