Serum Serotonin and Pruritus After Intrathecal Morphine in Cesarean Section

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-02

Study Completion Date

2016-09-21

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pruritus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Group I

intrathecal injection of 100 μg morphine

Group Type ACTIVE_COMPARATOR

Morphine 100 μg

Intervention Type DRUG

Intrathecal injection of morphine100 μg

Group II

iIntrathecal injection of 200 μg morphine

Group Type ACTIVE_COMPARATOR

Morphine 200 μg

Intervention Type DRUG

Intrathecal injection of morphine 200 μg

Interventions

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Morphine 100 μg

Intrathecal injection of morphine100 μg

Intervention Type DRUG

Morphine 200 μg

Intrathecal injection of morphine 200 μg

Intervention Type DRUG

Other Intervention Names

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M100 M200

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No