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Clinical Trials/NCT03209427
NCT03209427
Completed
Phase 4

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

Assiut University0 sites40 target enrollmentApril 2, 2014

Overview

Phase
Phase 4
Intervention
Morphine 100 μg
Conditions
Pruritus
Sponsor
Assiut University
Enrollment
40
Primary Endpoint
Pruritus
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2, 2014
End Date
September 21, 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed galal aly

Assistant professor

Assiut University

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.

Arms & Interventions

Group I

intrathecal injection of 100 μg morphine

Intervention: Morphine 100 μg

Group II

iIntrathecal injection of 200 μg morphine

Intervention: Morphine 200 μg

Outcomes

Primary Outcomes

Pruritus

Time Frame: 24 hours postoperative

severity

Secondary Outcomes

  • serotonin(4 hours postoperative)

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