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Early Phase 1 N=229 Randomized Single-blind Treatment

Comparison of 0.1 and 0.05mg Intrathecal Morphine for Post-cesarean Analgesia.

Cesarean Section

Enrolled (actual)
229
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Time to First Narcotic Rescue Dose in the First 24 Hours Post-cesarean Delivery. — NA; 23.5 hours

Study Design & Population

Study type
Interventional
Phase
Early Phase 1
Interventions
receiving 0.1 mg IT morphine (Drug); recieving 0.05 mg IT morphine (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Medical University of South Carolina
Primary completion
Aug 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Time to First Narcotic Rescue Dose in the First 24 Hours Post-cesarean Delivery.
NA; 23.5
SECONDARY
Time to First Ambulation After C-section
13.6; 13.7
SECONDARY
Opioid Medication Given During the Participant's Hospital Stay.
74; 74
SECONDARY
Subjective Pain Rating Using Visual Analogue Scales (VAS) Ranging From 0-100.
47.9; 49.6; 44.2; 45.9
SECONDARY
Presence of Opiate Side Effects (Nausea, Vomiting, and Pruritus)
68; 62; 21; 27; 11; 12
SECONDARY
Overall Patient Satisfaction With Pain Control
93.75; 94.5

Summary

The purpose of this study is to determine the ideal dose of spinal morphine for use in Cesarean section. Spinal anesthesia (single injection in the lower back to numb patients from the waist down) is commonly used in Cesarean section to provide numbness and pain relief during the surgery, and adding morphine to the spinal anesthetic provides long lasting pain relief for up to 24 hours after surgery. The ideal dose of spinal morphine, when given with other types of pain medications such as nonsteroidal anti-inflammatories and acetaminophen, has not been determined. In addition, spinal morphine can have side effects such as nausea and itching, so using a lower dose of morphine may decrease these side effects while providing the same amount of postoperative pain relief. Study participants will be divided into two groups. Group 1 will receive the standard dose of spinal morphine (0.1mg) while Group 2 will receive a lower dose of spinal morphine (0.05mg). Both groups will receive the standard dose of spinal bupivacaine (numbing medication) and spinal fentanyl (short acting pain medication). The additional pain medications (IV Toradol and oral acetaminophen) will be given to both groups after surgery. Pain control and morphine side effects will be compared between the two groups in order to determine the best dose of spinal morphine for cesarean section.

Eligibility Criteria

Inclusion Criteria

  • any parturient 18 years of age or older
  • undergoing elective cesarean delivery under spinal anesthesia
  • able to consent to the study and participate in the follow-up.

Exclusion Criteria

  • any known allergy to morphine
  • general anesthesia
  • urgent or emergent cases
  • any bleeding diathesis or other coagulopathy
  • known G6PD deficiency
  • any known liver disease
  • known alcohol abuse or dependence
  • HELLP syndrome
  • thrombocytopenia or known platelet dysfunction
  • history or active gastrointestinal bleeding
  • acute kidney injury or chronic renal insufficiency
  • contraindication/refusal to spinal anesthestic
  • chronic pain
  • chronic narcotic use
  • illicit drug use
  • allergy to any study related medications
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03427463). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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