Effect of Propofol Administration Time on the Incidence and Severity of Intrathecal Morphine-induced Pruritus in Parturient Undergoing Elective Cesarean Delivaries

Phase 4

Not yet recruiting

• Conditions: Cesarean Section
• Interventions: Drug: Morphine intrathecal; Drug: propofol

• Registration Number: NCT06715657
• Lead Sponsor: Assiut University

Brief Summary

Our hypothesis suggests that Administration time of intravenous propofol may affect Pruritus incidence and severity that occur after intrathecal morphine in parturient undergoing elective cesarean section (CS). the aim of the study is to investigate effect of prophylactic administration of intravenous sub-hypnotic dose of propofol before intrathecal morphine compared with the administration after intrathecal morphine on intrathecal morphine-induced pruritus incidence and severity in parturient undergoing elective cesarean delivaries.

Detailed Description

Neuraxial Anaesthesia is a frequent anaesthetic approach for cesarean delivery and other lower abdominal and lower limb anaesthetic procedures. Neuraxial morphine addition to local anaesthetic provides an effective and prolonged postoperative analgesia, but has been associated with a frequent incidence of pruritus and postoperative nausea and vomiting (PONV).

Neuraxial opioids are thought to act on central nervous system pathways to cause pruritus. Although precise mechanisms are incompletely understood, Numerous interventions have been investigated to prevent opioid-induced pruritus in the peripartum period as: Opioid receptor agonist-antagonists, Serotonin receptor antagonists.

There is dense concentration of opioid receptors and 5-HT3 receptors in the dorsal part of the spinal cord and nucleus of the spinal tract of the trigeminal nerve in the medulla. Activation of these receptors by neuraxial opioid administration or by circulating estrogen in parturient results in pruritus which is usually localized to face, neck, or upper thorax.

Propofol exerts its antipruritic action through inhibition of the posterior horn transmission in spinal cord. Series of clinical trials have reported that a sub-hypnotic dose of propofol is equally effective in reducing the incidence of pruritus following intrathecal morphine. however these studies have limited information about dose and timing of administration of propofol.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-29
• Study Start: 2024-12-01
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-04
• Last Update Posted: 2024-12-04
• Primary Completion: 2026-12-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 204

Inclusion Criteria

• Parturient of American Society of Anaesthesiologists (ASA) class I or II physical status.
• Age: 20-40 years.
• At term gestation (≥ 37 weeks) with a singleton uncomplicated pregnancy.
• Elective cesarean delivery under intrathecal anaesthesia

Exclusion Criteria

• Parturient refusal.

  • Significant organ dysfunctions (e.g., cardiac, respiratory, renal, or liver disorders).
  • Morbid obesity (BMI >35).
  • Parturient with known hypersensitivity to propofol, morphine or amide local anaesthetics.
  • Parturient with pruritogenic systemic disease.
  • A coexisting skin disorder or preexisting pregnancy induced pruritus.
  • Parturient with any contraindication for intrathecal anaesthesia, e.g. coagulopathy.
  • Emergency cesarean section.
  • Failed or unsatisfactory intrathecal block.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Morphine intrathecal	Patients will receive 0.5 mg/kg propofol diluted in 10 ml saline 0.9% IV injection 15 min before the end of surgery
Group B	Morphine intrathecal	Patients will receive 0.5 mg/kg propofol diluted in 10 ml saline 0.9% IV injection just before intrathecal anaesthesia
Group A	propofol	Patients will receive 0.5 mg/kg propofol diluted in 10 ml saline 0.9% IV injection 15 min before the end of surgery
Group B	propofol	Patients will receive 0.5 mg/kg propofol diluted in 10 ml saline 0.9% IV injection just before intrathecal anaesthesia
Group C	Morphine intrathecal	patients will receive intrathecal anaesthesia with morphine without other intervention

Primary Outcome Measures

Name	Time	Method
severity of pruritus that occurs after intrathecal morphine in parturient undergoing elective cesarean section (CS) by pruritus Grading system.	24 hours	the pruritus grading score (PGS) score (Firas et al, 2012) for each patient which is based on: distribution, frequency, severity of itch, and quality of sleep; Each patient's itch grade is calculated as the sum of the individual scores: Mild grade: if the total score is between 0 and 5. Moderate grade: if the total score is between 6 and 11. Severe grade: if the total score is between 12 and 19.