Comparison of Pruritus Incidence After Intrathecal Morphine 0.1 vs 0.2 mg in Cesarean Section
- 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
• Pregnant women aged 18-45 years
- Full-term pregnancy
- Scheduled for non-emergency cesarean section
- ASA physical status I-III
- Non-complicated pregnancy
- 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
Group Intervention Description ITM 0.1 mg Morphine Sulfate Participants receive spinal anesthesia with 0.5% hyperbaric bupivacaine plus morphine 0.1 mg intrathecally ITM 0.2 mg Morphine Sulfate Participants receive spinal anesthesia with 0.5% hyperbaric bupivacaine plus morphine 0.2 mg intrathecally
- Primary Outcome Measures
Name Time Method 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
Name Time Method
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, ThailandThepakorn Sathitkarnmanee, MDContact+66819547622thepakorns@gmail.comSirirat Tribuddharat, MD, PhDPrincipal Investigator