NCT03209427

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2014

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2015

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 6, 2017

Completed
Last Updated

July 6, 2017

Status Verified

July 1, 2017

Enrollment Period

1.1 years

First QC Date

July 4, 2017

Last Update Submit

July 4, 2017

Conditions

Pruritus

Keywords

morphine, pruritus, serotonin

Outcome Measures

Primary Outcomes (2)

  • Pruritus

    incidence

    24 hours postoperative

  • Pruritus

    severity

    24 hours postoperative

Secondary Outcomes (2)

  • serotonin

    preoperative

  • serotonin

    4 hours postoperative

Study Arms (2)

Group I

ACTIVE COMPARATOR

intrathecal injection of 100 μg morphine

Drug: Morphine 100 μg

Group II

ACTIVE COMPARATOR

iIntrathecal injection of 200 μg morphine

Drug: Morphine 200 μg

Interventions

Morphine 100 μgDRUG

Intrathecal injection of morphine100 μg

Also known as: M100
Group I
Morphine 200 μgDRUG

Intrathecal injection of morphine 200 μg

Also known as: M200
Group II

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA I - II term pregnant patients scheduled for elective cesarean section

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 18611915RESULT

MeSH Terms

Conditions

Pruritus

Interventions

Morphinevolociximab

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Mohamed G Aly, M.D.

    Assiut university faculty of medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 4, 2017

First Posted

July 6, 2017

Study Start

April 2, 2014

Primary Completion

April 30, 2015

Study Completion

September 21, 2016

Last Updated

July 6, 2017

Record last verified: 2017-07