Acute Postoperative PainPhase 1/2NCT04033471
Combined Epidural Morphine and Midazolam on Postoperative Pain
A Phase 1/2 study testing midazolam in people with Acute Postoperative Pain, run by Assiut University at 1 site in Egypt.
Trial summary
this study aim to Compare the effect of preoperative Epidural Midazolam, Morphine and their combination in postoperative pain relief and total morphine consumption. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Acute Postoperative Pain
- What is being tested?
- midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2019to Apr 2021
- Phase
- Phase 1/2
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II patients scheduled for major abdominal cancer surgeries
Who cannot join
- patients with known allergy to the study drugs,
- significant cardiac, respiratory, renal or hepatic disease,
- drug or alcohol abuse,
- psychiatric illness that would interfere with perception and assessment of pain.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut, 171516
Shereen M Kamal, Degree, 01006279209, sheridouh79@yahoo.com
Khaled M Fares, Professor, 01289757288, faressali@yahoo.com
About this study
Official title: Effect of Epidural Morphine and Midazolam on Postoperative Painin Patients Undergoing Major Abdominal Cancer Surgery
this study aim to Compare the effect of preoperative Epidural Midazolam, Morphine and their combination in postoperative pain relief and total morphine consumption.
Read the detailed description
Major abdominal surgeries with abdominal incisions lead to severe abdominal pain, which if treated inadequately, can cause shallow breathing, atelectasis, retention of secretions and lack of cooperation in physiotherapy. This increases the incidence of post-operative morbidity and leads to delayed recovery.Epidural anesthesia is safe and inexpensive technique with the advantage of providing surgical anesthesia and prolonged postoperative pain relief. It also an effective treatment of operative pain blunts autonomic, somatic and endocrine responses. Morphine and midazolam can be used as adjuvant to bupivicain to reduced the postoperative pain
- Conditions
- Acute Postoperative Pain
- Being tested
- midazolam
- Keywords
- epidural, morphine, midazolam, acute postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midazolamDrug
Also called morphine, bupivacaine
epidural needle in the L1-2 or L2-3 space , and using loss of resistance technique udder strict aseptic condition 10 ml of the prepared drug will be given
| Study group | Role | What they receive |
|---|---|---|
| MI | Active comparator | Bupivacaine 0.25% + midazolam 5mg in total volume 10m1 Receives: Drug: midazolam |
| MM | Active comparator | Bupivacaine 0.25% + midazolam 5mg and morphine 5mg in total volume 10ml Receives: Drug: midazolam |
| MO | Active comparator | bupivacaine 0.25% + morphine 5 mg in total volume 10 ml Receives: Drug: midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to first request of analgesia
the time between the end of operation and tracheal extubation to the first request for supplemental analgesics and its administration to the patient
Measured: 1st 48 hours postoperative
Secondary outcomes (1)
the cumulative consumption of morphine in the 1st 48h postoperatively
total amount of morphine used for analgesia
Measured: 1st 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 posted26 Jul 2019
- Study start1 Jul 2019
- Primary completionMar 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- epidural bupiviacain
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shereen Mamdouh, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033471
- Sponsor's protocol ID
- 464
- Status last verified
- Feb 2021
- First submitted
- 24 Jul 2019
- Last updated
- 24 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Epidural Morphine and Midazolam on Postoperative Painin Patients Undergoing Major Abdominal Cancer Surgery
- ClinicalTrials.gov ID
- NCT04033471
- Acronym / sponsor ID
- 464
- Conditions
- Acute Postoperative Pain
- Keywords
- epidural, morphine, midazolam, acute postoperative pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 26 Jul 2019 (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.
this study aim to Compare the effect of preoperative Epidural Midazolam, Morphine and their combination in postoperative pain relief and total morphine consumption.
Detailed description
Major abdominal surgeries with abdominal incisions lead to severe abdominal pain, which if treated inadequately, can cause shallow breathing, atelectasis, retention of secretions and lack of cooperation in physiotherapy. This increases the incidence of post-operative morbidity and leads to delayed recovery.Epidural anesthesia is safe and inexpensive technique with the advantage of providing surgical anesthesia and prolonged postoperative pain relief. It also an effective treatment of operative pain blunts autonomic, somatic and endocrine responses. Morphine and midazolam can be used as adjuvant to bupivicain to reduced the postoperative pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- epidural bupiviacain
| Arm | Type | Receives |
|---|---|---|
| MI | Active comparator | Drug: midazolamBupivacaine 0.25% + midazolam 5mg in total volume 10m1 |
| MM | Active comparator | Drug: midazolamBupivacaine 0.25% + midazolam 5mg and morphine 5mg in total volume 10ml |
| MO | Active comparator | Drug: midazolambupivacaine 0.25% + morphine 5 mg in total volume 10 ml |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I-II patients scheduled for major abdominal cancer surgeries
Key exclusion criteria (4 listed)
- patients with known allergy to the study drugs,
- significant cardiac, respiratory, renal or hepatic disease,
- drug or alcohol abuse,
- psychiatric illness that would interfere with perception and assessment of pain.
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 |
|---|---|---|
| midazolamAlso: morphine, bupivacaineepidural needle in the L1-2 or L2-3 space , and using loss of resistance technique udder strict aseptic condition 10 ml of the prepared drug will be given | Drug | MI, MM, MO |
Primary outcome
time to first request of analgesia
Time frame: 1st 48 hours postoperative
the time between the end of operation and tracheal extubation to the first request for supplemental analgesics and its administration to the patient
1 secondary outcome
the cumulative consumption of morphine in the 1st 48h postoperatively
Time frame: 1st 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 24 Feb 2021.
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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 Phase 1/2 study testing midazolam in people with Acute 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 1 inclusion and 4 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 24 Feb 2021. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Shereen M Kamal, Associate proferssor (01006279209, sheridouh79@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to first request of analgesia (time frame: 1st 48 hours postoperative). 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 Feb 2021.