Comparison of Pruritus Incidence After Intrathecal Morphine 0.1 vs 0.2 mg in Cesarean Section

Last updated: June 27, 2025
Sponsor: Khon Kaen University
Overall Status: Active - Recruiting

Phase

4

Condition

Hives (Urticaria)

Rash

Skin Wounds

Treatment

Morphine Sulfate

Clinical Study ID

NCT07054775
HE631484
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

Study Summary

This study compares the incidence of pruritus (itching) requiring treatment between two doses of intrathecal morphine (0.1 mg vs 0.2 mg) when used for spinal anesthesia during cesarean section. The study aims to determine if the lower dose (0.1 mg) can reduce pruritus incidence while maintaining adequate pain relief.

Eligibility Criteria

Inclusion

Inclusion Criteria: • Pregnant women aged 18-45 years

  • Full-term pregnancy

  • Scheduled for non-emergency cesarean section

  • ASA physical status I-III

  • Non-complicated pregnancy

Exclusion

Exclusion Criteria:

  • Contraindication to spinal anesthesia or study drugs

  • Refusal to participate in the study

  • BMI ≥ 40 kg/m²

  • History of systemic skin disease or current itchy skin condition

  • Use of antihistamines or anti-pruritic medications within 3 days prior to surgery

Study Design

Total Participants: 69
Treatment Group(s): 1
Primary Treatment: Morphine Sulfate
Phase: 4
Study Start date:
June 01, 2025
Estimated Completion Date:
November 30, 2025

Study Description

Spinal anesthesia is a standard technique for cesarean section. Intrathecal morphine (ITM) provides prolonged and effective analgesia but may cause adverse events including pruritus, nausea, vomiting, and respiratory depression. Current practice at Srinagarind Hospital uses ITM 0.2 mg for spinal anesthesia in cesarean section. This study investigates whether reducing the ITM dose to 0.1 mg can decrease pruritus incidence while preserving analgesic effectiveness.

Connect with a study center

  • Faculty of Medicine, Khon Kaen University

    Khon Kaen, 40002
    Thailand

    Active - Recruiting

  • Thepakorn Sathitkarnmanee

    Khon Kaen, 40002
    Thailand

    Active - Recruiting

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