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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorKhon Kaen University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Full-term pregnancy

Scheduled for non-emergency cesarean section

ASA physical status I-III

Non-complicated pregnancy

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Morphine Sulfate

    Drug

    intrathecal administered morphine

Treatment groups

69 Participants
are divided into 2 treatment groups
Group A: ITM 0.1 mgActive comparator 1 intervention
Group B: ITM 0.2 mgActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

* 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

Time frame
24 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

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