Post Operative PainPhase 2NCT05186454
Postoperative Pain Control by Use of Many Drugs in Small Doses Intrathecally
A Phase 2 study testing Morphine Sulfate, Bupivacaine and dexamethasone, morphine, midazolam in people with Post Operative Pain, run by Sohag University at 1 site in Egypt.
Trial summary
Cesarean section is one of the painful operations that require adequate postoperative analgesia. Patients are divided into two groups: Multimodal (DMM) group ( 30 patients): patients will receive spinal anesthesia with 10-12.5 mg bupivacaine and 1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Morphine Sulfate, Bupivacaine and dexamethasone, morphine, midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 23 May 2021to 15 Feb 2022
- Phase
- Phase 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA I-II
- Age 20-40 years.
- Pregnant women with living fetus.
- Body mass index 20- 35 kg/m2.
Who cannot join
- Patient refusal.
- Age < 20 or > 40 years
- Body mass index < 20 or > 35.
- Contraindication to spinal anesthesia (severe mitral or aortic stenosis, coagulopathy, Systemic or local infection, increased intracranial pressure and hypovolemia).
- Placental abnormalities: placental abruption, placenta previa or accrete.
- Allergy to drugs used in the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Fouad Soliman
Sohag, 52514
Fouad Soliman, 01113815186, fouad_soliman@med.sohag.edu.eg
About this study
Official title: Multimodal Intrathecal Analgesia for Cesarean Section
Cesarean section is one of the painful operations that require adequate postoperative analgesia. Patients are divided into two groups: Multimodal (DMM) group ( 30 patients): patients will receive spinal anesthesia with 10-12.5 mg bupivacaine and 1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam.
Morphine (M) group (30 patients): patients will receive spinal anesthesia with 10-12.5 mg bupivacaine and 1 ml containing 200 µg morphine
- Conditions
- Post Operative Pain
- Being tested
- Morphine Sulfate, Bupivacaine, dexamethasone, morphine, midazolam
- Keywords
- Intrathecal morphine, midazolam, dexamethasone, cesarean section
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine SulfateDrug
Also called bupivacaine
analgesia
BupivacaineDrug
Analgesia
dexamethasone, morphine, midazolamDrug
1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam
| Study group | Role | What they receive |
|---|---|---|
| Morphine | Active comparator | Patients will receive 10-12.5 mg bupivacaine and 1 ml containing 200 µg of morphine intrathecally. Receives: Drug: Morphine Sulfate; Drug: Bupivacaine |
| Multimodal | Active comparator | Patients will receive 10-12.5 mg bupivacaine and 1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam intrathecally Receives: Drug: Bupivacaine; Drug: dexamethasone, morphine, midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
1st analgesic requirement
The first time of supplemental analgesic need postoperatively
Measured: 24 hours
Secondary outcomes (3)
Analgesic consumption
Total analgesic consumption
Measured: 24 hours
Post operative pain
Visual Analog Scale(0-10 with 0 is no pain and 10 is maximum intolerable pain)
Measured: 24 hours
Side effects
- Pruritus (assessed the number of patients suffering from pruritus and grading the degree as follow:Mild= Itching is a minor concern, Moderate = Itching is a primary concern, but bearable,Severe= Unbearable; patient need anti-histaminic treatment.
- Nausea and/or vomiting(assessed on 4 grade scales:
0= no symptoms present, 1 =mild nausea with no need for pharmacological treatment, 2= moderate nausea that required treatment (ondansetron 4 mg), 3= severe nausea that is resistant to treatment).
3-Sedation (assessed on 4 grade scale: 1-awake and alert, 2 -slightly drowsy, easily aroused, 3 -drowsy, drifts off to sleep during conversation, 4 -somnolent, minimal, or no response to physical stimulation).
4- Respiratory depression whether present or not(Respiratory depression was defined as a respiratory rate ≤10/min.)
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 posted11 Jan 2022
- Study start23 May 2021
- Primary completion10 Feb 2022 (estimated)
- Study completion15 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Sohag 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 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fouad Soliman, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186454
- Sponsor's protocol ID
- 2008
- Status last verified
- Jan 2022
- First submitted
- 26 Dec 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Intrathecal Analgesia for Cesarean Section
- ClinicalTrials.gov ID
- NCT05186454
- Acronym / sponsor ID
- 2008
- Conditions
- Post Operative Pain
- Keywords
- Intrathecal morphine, midazolam, dexamethasone, cesarean section
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 23 May 2021 (actual)
- Primary completion
- 10 Feb 2022 (estimated)
- Study completion
- 15 Feb 2022 (estimated)
- First posted
- 11 Jan 2022 (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.
Cesarean section is one of the painful operations that require adequate postoperative analgesia. Patients are divided into two groups: Multimodal (DMM) group ( 30 patients): patients will receive spinal anesthesia with 10-12.5 mg bupivacaine and 1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam.
Morphine (M) group (30 patients): patients will receive spinal anesthesia with 10-12.5 mg bupivacaine and 1 ml containing 200 µg morphine
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morphine | Active comparator | Drug: Morphine Sulfate, Drug: BupivacainePatients will receive 10-12.5 mg bupivacaine and 1 ml containing 200 µg of morphine intrathecally. |
| Multimodal | Active comparator | Drug: Bupivacaine, Drug: dexamethasone, morphine, midazolamPatients will receive 10-12.5 mg bupivacaine and 1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam intrathecally |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA I-II
- Age 20-40 years.
- Pregnant women with living fetus.
- Body mass index 20- 35 kg/m2.
Key exclusion criteria (6 listed)
- Patient refusal.
- Age < 20 or > 40 years
- Body mass index < 20 or > 35.
- Contraindication to spinal anesthesia (severe mitral or aortic stenosis, coagulopathy, Systemic or local infection, increased intracranial pressure and hypovolemia).
- Placental abnormalities: placental abruption, placenta previa or accrete.
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 |
|---|---|---|
| Morphine SulfateAlso: bupivacaineanalgesia | Drug | Morphine |
| BupivacaineAnalgesia | Drug | Morphine, Multimodal |
| dexamethasone, morphine, midazolam1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam | Drug | Multimodal |
Primary outcome
1st analgesic requirement
Time frame: 24 hours
The first time of supplemental analgesic need postoperatively
3 secondary outcomes
Analgesic consumption
Time frame: 24 hours
Post operative pain
Time frame: 24 hours
Side effects
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Post Operative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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 2 study testing Morphine Sulfate, Bupivacaine and dexamethasone, morphine, midazolam in people with Post Operative Pain, run by Sohag 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 4 inclusion and 6 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 28 Jan 2022. 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 phase mean?
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 Fouad Soliman (01113815186, fouad_soliman@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1st analgesic requirement (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 28 Jan 2022.