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: Drug: Morphine Sulfate

• 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.

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted: 2025-06-27
• Study First Submitted QC: 2025-06-27
• Last Update Submitted: 2025-06-27
• Study First Posted: 2025-07-08
• Last Update Posted: 2025-07-08
• Primary Completion: 2025-10-31
• Study Completion: 2025-11-30

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

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

Trial Locations

Locations (2)

Faculty of Medicine, Khon Kaen University; 🇹🇭 Khon Kaen, Thailand

Thepakorn Sathitkarnmanee; 🇹🇭 Khon Kaen, Thailand