Postoperative PainNCT03230227
Presternal Magnesium With Bupivacain Versus Bupivacain Only for Postoperative Pain Relief in Open Heart Surgery
A study testing Bupivacaine magnesium and Bupivacaine only in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.
Trial summary
Effective pain relief after cardiac surgery has assumed importance with the introduction of fast track discharge protocols that requires early weaning from mechanical ventilation. Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of atelectasis, and prolongs recovery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bupivacaine magnesium and Bupivacaine only
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2015to Feb 2017
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-60 years old
- American Society of Anesthesiologists physical status II and III
- Patients scheduled for open heart surgery with sternotomy
Who cannot join
- - Emergency surgery
- Clinically significant kidney or liver disease
- Patients allergic to local anesthetic
- Patients with prolonged CPB time (>120 min)
- Patients required intra-aortic balloon pump
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Presternal Local Analgesia for Postoperative Pain Relief After Open Heart Surgery
Effective pain relief after cardiac surgery has assumed importance with the introduction of fast track discharge protocols that requires early weaning from mechanical ventilation. Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of atelectasis, and prolongs recovery. Infiltration of local anesthetics near the surgical wound has shown to improve early postoperative pain in various surgical procedures.
Magnesium is the fourth most plentiful cation in our body. It has antinociceptive effects in animal and human models of pain.
Read the detailed description
Effective pain relief after cardiac surgery has assumed importance with the introduction of fast track discharge protocols that requires early weaning from mechanical ventilation. Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of atelectasis, and prolongs recovery.
A major cause of pain after cardiac surgery is the median sternotomy particularly on the first two postoperative days.
The most often used analgesics in these patients are parenteral opioids which can lead to undesirable side-effects as sedation, respiratory depression, nausea, and vomiting.
Infiltration of local anesthetics near the surgical wound has shown to improve early postoperative pain in various surgical procedures.
Magnesium is the fourth most plentiful cation in our body. It has antinociceptive effects in animal and human models of pain.
It has been mentioned in a systematic review that it may be worthwhile to further study the role of supplemental magnesium in providing perioperative analgesia, because this is a relatively harmless molecule, is not expensive and also because the biological basis for its potential antinociceptive effect is promising.
These effects are primarily based on physiological calcium antagonism, that is voltage-dependent regulation of calcium influx into the cell, and noncompetitive antagonism of N-methyl-D-aspartate (NMDA) receptors.
there is a need to evaluate and compare local magnesium with bupivacaine , in comparison to bupivacain
- Conditions
- Postoperative Pain
- Being tested
- Bupivacaine magnesium, Bupivacaine only
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine magnesiumDrug
bupivacain 0.125% magnesium sulfate 5%) infusion in the presternum , for 48 hours
Bupivacaine onlyDrug
bupivacaine 0.125% infusion in the presternum , for 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine magnesium | Active comparator | ( bupivacain 0.125% magnesium sulfate 5%) infusion in the presternum , for 48 hours Receives: Drug: Bupivacaine magnesium |
| bupivacain only | Active comparator | bupivacaine 0.125% infusion in the presternum , for 48 hours Receives: Drug: Bupivacaine only |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
assessing VAS scale
Measured: 2 days
Secondary outcomes (1)
hemodynamics
mean arterial blood pressure
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study startFeb 2015
- Primary completionDec 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- post open heart surgery pain alleviation
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Zarief , MD, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230227
- Sponsor's protocol ID
- IRB00009912
- Status last verified
- Nov 2017
- First submitted
- 14 Jul 2017
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presternal Local Analgesia for Postoperative Pain Relief After Open Heart Surgery
- ClinicalTrials.gov ID
- NCT03230227
- Acronym / sponsor ID
- IRB00009912
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 26 Jul 2017 (actual)
- 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.
Effective pain relief after cardiac surgery has assumed importance with the introduction of fast track discharge protocols that requires early weaning from mechanical ventilation. Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of atelectasis, and prolongs recovery. Infiltration of local anesthetics near the surgical wound has shown to improve early postoperative pain in various surgical procedures.
Magnesium is the fourth most plentiful cation in our body. It has antinociceptive effects in animal and human models of pain.
Detailed description
Effective pain relief after cardiac surgery has assumed importance with the introduction of fast track discharge protocols that requires early weaning from mechanical ventilation. Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of atelectasis, and prolongs recovery.
A major cause of pain after cardiac surgery is the median sternotomy particularly on the first two postoperative days.
The most often used analgesics in these patients are parenteral opioids which can lead to undesirable side-effects as sedation, respiratory depression, nausea, and vomiting.
Infiltration of local anesthetics near the surgical wound has shown to improve early postoperative pain in various surgical procedures.
Magnesium is the fourth most plentiful cation in our body. It has antinociceptive effects in animal and human models of pain.
It has been mentioned in a systematic review that it may be worthwhile to further study the role of supplemental magnesium in providing perioperative analgesia, because this is a relatively harmless molecule, is not expensive and also because the biological basis for its potential antinociceptive effect is promising.
These effects are primarily based on physiological calcium antagonism, that is voltage-dependent regulation of calcium influx into the cell, and noncompetitive antagonism of N-methyl-D-aspartate (NMDA) receptors.
there is a need to evaluate and compare local magnesium with bupivacaine , in comparison to bupivacain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- post open heart surgery pain alleviation
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine magnesium | Active comparator | Drug: Bupivacaine magnesium( bupivacain 0.125% magnesium sulfate 5%) infusion in the presternum , for 48 hours |
| bupivacain only | Active comparator | Drug: Bupivacaine onlybupivacaine 0.125% infusion in the presternum , for 48 hours |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-60 years old
- American Society of Anesthesiologists physical status II and III
- Patients scheduled for open heart surgery with sternotomy
Key exclusion criteria (5 listed)
- - Emergency surgery
- Clinically significant kidney or liver disease
- Patients allergic to local anesthetic
- Patients with prolonged CPB time (>120 min)
- Patients required intra-aortic balloon pump
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 magnesiumbupivacain 0.125% magnesium sulfate 5%) infusion in the presternum , for 48 hours | Drug | Bupivacaine magnesium |
| Bupivacaine onlybupivacaine 0.125% infusion in the presternum , for 48 hours | Drug | bupivacain only |
Primary outcome
postoperative pain
Time frame: 2 days
assessing VAS scale
1 secondary outcome
hemodynamics
Time frame: 24 hours
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 24 Nov 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 magnesium and Bupivacaine only in people with Postoperative Pain, run by Assiut 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 3 inclusion and 5 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 24 Nov 2017. 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. 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?
postoperative pain (time frame: 2 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 24 Nov 2017.