Serum Serotonin and Pruritus After Intrathecal Morphine in Cesarean Section

Pruritus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03209427
• Other study ID #: 17100209
• Status: Completed
• Phase: Phase 4
• First received: July 4, 2017
• Last updated: July 4, 2017
• Start date: April 2, 2014
• Est. completion date: September 21, 2016

Study information

• Verified date: July 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 21, 2016
• Est. primary completion date: April 30, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pruritus

Intervention

Drug:
• Morphine 100 µg
Intrathecal injection of morphine100 µg
• Morphine 200 µg
Intrathecal injection of morphine 200 µg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (1)

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. Revi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pruritus	incidence	24 hours postoperative
Primary	Pruritus	severity	24 hours postoperative
Secondary	serotonin	Serum level	preoperative
Secondary	serotonin	Serum level	4 hours postoperative