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Recruiting NCT07054775

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

Phase IV Interventional Pruritus Caused by Drug

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Morphine Sulfate.
Who it may be relevant to
Registry conditions: Pruritus Caused by Drug. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparison of Pruritus Incidence After Intrathecal Morphine 0.1 and 0.2 Milligrams in Cesarean Section: A Randomized Clinical Trial

Overview

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.

Interventions

  • Drug Morphine Sulfate
    intrathecal administered morphine

Primary outcome measures

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

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Thailand · 2 centers
  • Faculty of Medicine, Khon Kaen University — Khon Kaen
  • Thepakorn Sathitkarnmanee — Khon Kaen

Publications

  • Kumar K, Singh SI. Neuraxial opioid-induced pruritus: An update. J Anaesthesiol Clin Pharmacol. 2013 Jul;29(3):303-7. doi: 10.4103/0970-9185.117045. PMID 24106351
  • Waxler B, Dadabhoy ZP, Stojiljkovic L, Rabito SF. Primer of postoperative pruritus for anesthesiologists. Anesthesiology. 2005 Jul;103(1):168-78. doi: 10.1097/00000542-200507000-00025. PMID 15983470
  • Sultan P, Halpern SH, Pushpanathan E, Patel S, Carvalho B. The Effect of Intrathecal Morphine Dose on Outcomes After Elective Cesarean Delivery: A Meta-Analysis. Anesth Analg. 2016 Jul;123(1):154-64. doi: 10.1213/ANE.0000000000001255. PMID 27089000
  • Gehling M, Tryba M. Risks and side-effects of intrathecal morphine combined with spinal anaesthesia: a meta-analysis. Anaesthesia. 2009 Jun;64(6):643-51. doi: 10.1111/j.1365-2044.2008.05817.x. PMID 19462494
  • Palmer CM, Emerson S, Volgoropolous D, Alves D. Dose-response relationship of intrathecal morphine for postcesarean analgesia. Anesthesiology. 1999 Feb;90(2):437-44. doi: 10.1097/00000542-199902000-00018. PMID 9952150
  • Wang W, Zhou L, Sun L. Ondansetron for neuraxial morphine-induced pruritus: A meta-analysis of randomized controlled trials. J Clin Pharm Ther. 2017 Aug;42(4):383-393. doi: 10.1111/jcpt.12539. Epub 2017 May 2. PMID 28464238

Identifiers

NCT: NCT07054775 · HE631484

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗