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

Khon Kaen University

Status and phase: Enrolling; Phase 4

Conditions: Pruritus Caused by Drug

Treatments: Drug: Morphine Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT07054775

HE631484

Details and patient eligibility

About

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.

Full 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.

Enrollment: 69 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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69 participants in 2 patient groups

ITM 0.1 mg

Active Comparator group

Description:

Participants receive spinal anesthesia with 0.5% hyperbaric bupivacaine plus morphine 0.1 mg intrathecally

Treatment:

Drug: Morphine Sulfate

ITM 0.2 mg

Active Comparator group

Description:

Participants receive spinal anesthesia with 0.5% hyperbaric bupivacaine plus morphine 0.2 mg intrathecally

Treatment:

Drug: Morphine Sulfate