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

Not Applicable
Recruiting
Conditions
Pruritus Caused by Drug
Interventions
Registration Number
NCT07054775
Lead Sponsor
Khon Kaen University
Brief 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.

Detailed 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.

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
69
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ITM 0.1 mgMorphine SulfateParticipants receive spinal anesthesia with 0.5% hyperbaric bupivacaine plus morphine 0.1 mg intrathecally
ITM 0.2 mgMorphine SulfateParticipants receive spinal anesthesia with 0.5% hyperbaric bupivacaine plus morphine 0.2 mg intrathecally
Primary Outcome Measures
NameTimeMethod
Incidence of pruritus requiring treatment [Time Frame: 24 hours post-operatively]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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Faculty of Medicine, Khon Kaen University

🇹🇭

Khon Kaen, Thailand

Thepakorn Sathitkarnmanee

🇹🇭

Khon Kaen, Thailand

Faculty of Medicine, Khon Kaen University
🇹🇭Khon Kaen, Thailand
Thepakorn Sathitkarnmanee, MD
Contact
+66819547622
thepakorns@gmail.com
Sirirat Tribuddharat, MD, PhD
Principal Investigator

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