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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
Sponsor:
Information provided by (Responsible Party):
Mohamed galal aly, Assiut University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Pruritus Drug: Morphine 100 μg Drug: Morphine 200 μg Phase 4

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
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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

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Arms and Interventions
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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
 Drug: Morphine 200 μg
Intrathecal injection of morphine 200 μg
Other Name: M200


Outcome Measures
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Primary Outcome Measures :
  1. Pruritus [ Time Frame: 24 hours postoperative ]
    incidence

  2. Pruritus [ Time Frame: 24 hours postoperative ]
    severity


Secondary Outcome Measures :
  1. serotonin [ Time Frame: preoperative ]
    Serum level

  2. serotonin [ Time Frame: 4 hours postoperative ]
    Serum level


Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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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


Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Mohamed G Aly, M.D. Assiut university faculty of medicine
More Information
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Publications of Results:

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed galal aly, Assiut University:
morphine, pruritus, serotonin
Additional relevant MeSH terms:
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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