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NCT Number: NCT07054775

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

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.

Recruiting

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Key information

Conditions

Pruritus Caused by Drug

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

Morphine sulfate

Drug

intrathecal administered morphine

Primary outcomes

  1. Incidence of pruritus requiring treatment [Time Frame: 24 hours post-operatively]

    Time frame: 24 hours

    • Percentage of participants requiring treatment for pruritus within 24 hours after spinal anesthesia
    • Measured using numerical rating scale (0-10), with treatment indicated for score ≥4
    • Percentage of participants requiring treatment for pruritus within 24 hours after spinal anesthesia
    • Measured using numerical rating scale (0-10), with treatment indicated for score ≥4
    • Percentage of participants requiring treatment for pruritus within 24 hours after spinal anesthesia
    • Measured using numerical rating scale (0-10), with treatment indicated for score ≥4

Study contacts

Contact information is provided by the study sponsor or research team.

Sirirat Tribuddharat

CONTACT

[email protected]

66-81-6205920

Thepakorn Sathitkarnbmanee

CONTACT

[email protected]

66-81-9547622

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study title

Comparison of Pruritus Incidence After Intrathecal Morphine 0.1 and 0.2 Milligrams in Cesarean Section: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 8, 2025
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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