Serum Serotonin and Pruritus After Intrathecal Morphine in Cesarean Section

Phase 4

Completed

• Conditions: Pruritus
• Interventions: Drug: Morphine 100 μg; Drug: Morphine 200 μg

• Registration Number: NCT03209427
• Lead Sponsor: Assiut University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2014-04-02
• Primary Completion: 2015-04-30
• Study Completion: 2016-09-21
• Status Verified: 2017-07
• Study First Submitted: 2017-07-04
• Study First Submitted QC: 2017-07-04
• Last Update Submitted: 2017-07-04
• Study First Posted: 2017-07-06
• Last Update Posted: 2017-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	Morphine 100 μg	intrathecal injection of 100 μg morphine
Group II	Morphine 200 μg	iIntrathecal injection of 200 μg morphine

Primary Outcome Measures

Name	Time	Method
Pruritus	24 hours postoperative	severity

Secondary Outcome Measures

Name	Time	Method
serotonin	4 hours postoperative	Serum level