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Serum Serotonin and Pruritus After Intrathecal Morphine in Cesarean Section

Primary Purpose

Pruritus

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Morphine 100 μg

Morphine 200 μg

About this trial

This is an interventional diagnostic trial for Pruritus focused on measuring morphine, pruritus, serotonin

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group I

Group II

Arm Description

intrathecal injection of 100 μg morphine

iIntrathecal injection of 200 μg morphine

Outcomes

Primary Outcome Measures

Pruritus

incidence

Pruritus

severity

Secondary Outcome Measures

serotonin

Serum level

serotonin

Serum level

Full Information

NCT ID

NCT03209427

First Posted

July 4, 2017

Last Updated

July 4, 2017

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT03209427

Brief Title

Serum Serotonin and Pruritus After Intrathecal Morphine in Cesarean Section

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

April 2, 2014 (Actual)

Primary Completion Date

April 30, 2015 (Actual)

Study Completion Date

September 21, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pruritus

Keywords

morphine, pruritus, serotonin

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group I

Arm Type

Active Comparator

Arm Description

intrathecal injection of 100 μg morphine

Arm Title

Group II

Arm Type

Active Comparator

Arm Description

iIntrathecal injection of 200 μg morphine

Intervention Type

Drug

Intervention Name(s)

Morphine 100 μg

Other Intervention Name(s)

M100

Intervention Description

Intrathecal injection of morphine100 μg

Intervention Type

Drug

Intervention Name(s)

Morphine 200 μg

Other Intervention Name(s)

M200

Intervention Description

Intrathecal injection of morphine 200 μg

Primary Outcome Measure Information:

Title

Pruritus

Description

incidence

Time Frame

24 hours postoperative

Title

Pruritus

Description

severity

Time Frame

24 hours postoperative

Secondary Outcome Measure Information:

Title

serotonin

Description

Serum level

Time Frame

preoperative

Title

serotonin

Description

Serum level

Time Frame

4 hours postoperative

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamed G Aly, M.D.

Organizational Affiliation

Assiut university faculty of medicine

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

18611915

Citation

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.

Results Reference

result

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Serum Serotonin and Pruritus After Intrathecal Morphine in Cesarean Section

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