Serum Serotonin and Pruritus After Intrathecal Morphine in Cesarean Section

July 4, 2017 updated by: Mohamed galal aly, Assiut University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I
intrathecal injection of 100 μg morphine
Drug: Morphine 100 μg
Intrathecal injection of morphine100 μg
Other Names:
  • M100
Active Comparator: Group II
iIntrathecal injection of 200 μg morphine
Drug: Morphine 200 μg
Intrathecal injection of morphine 200 μg
Other Names:
  • M200

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pruritus
Time Frame: 24 hours postoperative
incidence
24 hours postoperative
Pruritus
Time Frame: 24 hours postoperative
severity
24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serotonin
Time Frame: preoperative
Serum level
preoperative
serotonin
Time Frame: 4 hours postoperative
Serum level
4 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Mohamed G Aly, M.D., Assiut university faculty of medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2014

Primary Completion (Actual)

April 30, 2015

Study Completion (Actual)

September 21, 2016

Study Registration Dates

First Submitted

July 4, 2017

First Submitted That Met QC Criteria

July 4, 2017

First Posted (Actual)

July 6, 2017

Study Record Updates

Last Update Posted (Actual)

July 6, 2017

Last Update Submitted That Met QC Criteria

July 4, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17100209

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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