Serum Serotonin and Pruritus After Intrathecal Morphine in Cesarean Section
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ClinicalTrials.gov Identifier: NCT03209427 |
Recruitment Status :
Completed
First Posted : July 6, 2017
Last Update Posted : July 6, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pruritus | Drug: Morphine 100 μg Drug: Morphine 200 μg | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Diagnostic |
Official Title: | Pruritus After Intrathecal Morphine in Cesarean Section: Incidence, Severity and Its Relation to Serum Serotonin Level |
Actual Study Start Date : | April 2, 2014 |
Actual Primary Completion Date : | April 30, 2015 |
Actual Study Completion Date : | September 21, 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Group I
intrathecal injection of 100 μg morphine
|
Drug: Morphine 100 μg
Intrathecal injection of morphine100 μg
Other Name: M100 |
Active Comparator: Group II
iIntrathecal injection of 200 μg morphine
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Drug: Morphine 200 μg
Intrathecal injection of morphine 200 μg
Other Name: M200 |
- Pruritus [ Time Frame: 24 hours postoperative ]incidence
- Pruritus [ Time Frame: 24 hours postoperative ]severity
- serotonin [ Time Frame: preoperative ]Serum level
- serotonin [ Time Frame: 4 hours postoperative ]Serum level

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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ASA I - II term pregnant patients scheduled for elective cesarean section
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209427
Principal Investigator: | Mohamed G Aly, M.D. | Assiut university faculty of medicine |
Responsible Party: | Mohamed galal aly, Assistant professor, Assiut University |
ClinicalTrials.gov Identifier: | NCT03209427 |
Other Study ID Numbers: |
17100209 |
First Posted: | July 6, 2017 Key Record Dates |
Last Update Posted: | July 6, 2017 |
Last Verified: | July 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
morphine, pruritus, serotonin |
Pruritus Skin Diseases Skin Manifestations Morphine Analgesics, Opioid Narcotics |
Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |