PruritusPhase 4NCT03209427
Serum Serotonin and Pruritus After Intrathecal Morphine in Cesarean Section
A Phase 4 study testing Morphine 100 μg and Morphine 200 μg in people with Pruritus, run by Assiut University.
Trial summary
Pruritus is the commonest side effect of intrathecal morphine especially in parturient, but the exact mechanism of pruritus is not clear. Many mechanisms have been suggested. Among these mechanisms is the activation of the 5-HT3 receptors by the intrathecally injected morphine. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pruritus
- What is being tested?
- Morphine 100 μg and Morphine 200 μg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 2 Apr 2014to 21 Sep 2016
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA I - II term pregnant patients scheduled for elective cesarean section
Who cannot join
- patients with a known allergy to the study drugs
- significant cardiac, respiratory, renal, neurological, or hepatic disease; -coagulation disorders
- BMI > 30 kg/m2
- any itchy skin diseases.
About this study
Official title: Pruritus After Intrathecal Morphine in Cesarean Section: Incidence, Severity and Its Relation to Serum Serotonin Level
Pruritus is the commonest side effect of intrathecal morphine especially in parturient, but the exact mechanism of pruritus is not clear. Many mechanisms have been suggested. Among these mechanisms is the activation of the 5-HT3 receptors by the intrathecally injected morphine.
Read the detailed description
Forty parturients underwent elective cesarean section under spinal anesthesia were divided into two groups of 20 each in this prospective randomized study. Group I received 100 µg of intrathecal morphine (ITM) mixed with 12 mg of 0.5% heavy bupivacaine (M100) while group II received 200 µg of ITM mixed with 12 mg of 0.5% heavy bupivacaine (M200). Two blood samples were taken from each patient for serotonin estimation, preoperatively and 4 hrs later. Postoperatively all patients were assessed for pruritus (incidence \& severity), visual analog scale (VAS), first request of analgesia, and total analgesic dose required within 24 hrs.
- Conditions
- Pruritus
- Being tested
- Morphine 100 μg, Morphine 200 μg
- Keywords
- morphine, pruritus, serotonin
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine 100 μgDrug
Also called M100
Intrathecal injection of morphine100 μg
Morphine 200 μgDrug
Also called M200
Intrathecal injection of morphine 200 μg
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | intrathecal injection of 100 μg morphine Receives: Drug: Morphine 100 μg |
| Group II | Active comparator | iIntrathecal injection of 200 μg morphine Receives: Drug: Morphine 200 μg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pruritus
incidence
Measured: 24 hours postoperative
Pruritus
severity
Measured: 24 hours postoperative
Secondary outcomes (2)
serotonin
Serum level
Measured: preoperative
serotonin
Serum level
Measured: 4 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start2 Apr 2014
- Primary completion30 Apr 2015
- Study completion21 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PruritusStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed galal aly, Assiut University
- Investigators
- Mohamed G Aly, M.D., Principal investigator, Assiut university faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209427
- Sponsor's protocol ID
- 17100209
- Status last verified
- Jul 2017
- First submitted
- 4 Jul 2017
- Last updated
- 6 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bonnet MP, Marret E, Josserand J, Mercier FJ. Effect of prophylactic 5-HT3 receptor antagonists on pruritus induced by neuraxial opioids: a quantitative systematic review. Br J Anaesth. 2008 Sep;101(3):311-9. doi: 10.1093/bja/aen202. Epub 2008 Jul 7.
PubMed 18611915
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pruritus After Intrathecal Morphine in Cesarean Section: Incidence, Severity and Its Relation to Serum Serotonin Level
- ClinicalTrials.gov ID
- NCT03209427
- Acronym / sponsor ID
- 17100209
- Conditions
- Pruritus
- Keywords
- morphine, pruritus, serotonin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 2 Apr 2014 (actual)
- Primary completion
- 30 Apr 2015 (actual)
- Study completion
- 21 Sep 2016 (actual)
- First posted
- 6 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.
Pruritus is the commonest side effect of intrathecal morphine especially in parturient, but the exact mechanism of pruritus is not clear. Many mechanisms have been suggested. Among these mechanisms is the activation of the 5-HT3 receptors by the intrathecally injected morphine.
Detailed description
Forty parturients underwent elective cesarean section under spinal anesthesia were divided into two groups of 20 each in this prospective randomized study. Group I received 100 µg of intrathecal morphine (ITM) mixed with 12 mg of 0.5% heavy bupivacaine (M100) while group II received 200 µg of ITM mixed with 12 mg of 0.5% heavy bupivacaine (M200). Two blood samples were taken from each patient for serotonin estimation, preoperatively and 4 hrs later. Postoperatively all patients were assessed for pruritus (incidence \& severity), visual analog scale (VAS), first request of analgesia, and total analgesic dose required within 24 hrs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Drug: Morphine 100 μgintrathecal injection of 100 μg morphine |
| Group II | Active comparator | Drug: Morphine 200 μgiIntrathecal injection of 200 μg morphine |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA I - II term pregnant patients scheduled for elective cesarean section
Key exclusion criteria (4 listed)
- patients with a known allergy to the study drugs
- significant cardiac, respiratory, renal, neurological, or hepatic disease; -coagulation disorders
- BMI > 30 kg/m2
- any itchy skin diseases.
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 100 μgAlso: M100Intrathecal injection of morphine100 μg | Drug | Group I |
| Morphine 200 μgAlso: M200Intrathecal injection of morphine 200 μg | Drug | Group II |
Primary outcome
Pruritus
Time frame: 24 hours postoperative
incidence
Pruritus
Time frame: 24 hours postoperative
severity
2 secondary outcomes
serotonin
Time frame: preoperative
serotonin
Time frame: 4 hours postoperative
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 6 Jul 2017.
- Results publication: PubMed 18611915Bonnet MP, Marret E, Josserand J, Mercier FJ. Effect of prophylactic 5-HT3 receptor antagonists on pruritus induced by neuraxial opioids: a quantitative systematic review. Br J Anaesth. 2008 Sep;101(3):311-9. doi: 10.1093/bja/aen202. Epub 2008 Jul 7.
- 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.
Mohamed G Aly, M.D. principal investigator
Assiut university faculty of medicine
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Morphine 100 μg and Morphine 200 μg in people with Pruritus, run by Assiut University.
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: finished, as of the sponsor's last update on 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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 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 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?
Pruritus (time frame: 24 hours postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03209427, which also lists 1 linked publication.
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 6 Jul 2017.