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NCT Number: NCT03209427

Serum Serotonin and Pruritus After Intrathecal Morphine in Cesarean Section

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.

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Key information

Conditions

Pruritus Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Morphine 100 μg

Drug

Intrathecal injection of morphine100 μg

Other names: M100

Morphine 200 μg

Drug

Intrathecal injection of morphine 200 μg

Other names: M200

Primary outcomes

  1. Pruritus

    Time frame: 24 hours postoperative

    incidence

  2. Pruritus

    Time frame: 24 hours postoperative

    severity

Secondary outcomes

  1. serotonin

    Time frame: preoperative

    Serum level

  2. serotonin

    Time frame: 4 hours postoperative

    Serum level

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Pruritus After Intrathecal Morphine in Cesarean Section: Incidence, Severity and Its Relation to Serum Serotonin Level

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jul 6, 2017
Registry last updated
Jul 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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