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Completed

NCT Number: NCT03427463

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

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.

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Key information

Conditions

Cesarean Section

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

receiving 0.1 mg IT morphine

Drug

Patients will receive the standard of care dose 0.1 mg of intrathecal morphine

recieving 0.05 mg IT morphine

Drug

Patients will receive 0.05 mg of intrathecal morphine

Primary outcomes

  1. Time to First Narcotic Rescue Dose in the First 24 Hours Post-cesarean Delivery.

    Time frame: 24 hours

    This is defined as the number of hours until the first rescue dose of medication was given to participants within the first 24-hours post-op.

Secondary outcomes

  1. Time to First Ambulation After C-section

    Time frame: up to 48 hours

    This outcome evaluated the amount of time reported in hours after c-section the patient first ambulated.

  2. Opioid Medication Given During the Participant's Hospital Stay.

    Time frame: From the time of the procedure through discharge, up to 48 hours.

    This outcome looks at whether or not any opioid medications were given during the participant's hospital stay, reporting the number of subjects who received opioid pain medication during the admission.

  3. Subjective Pain Rating Using Visual Analogue Scales (VAS) Ranging From 0-100.

    Time frame: 24-hours post operatively and 48-hours post operatively

    Subjective pain with ambulation reported by participants using visual analogue scales (VAS) ranging from 0-100 at the 24-hour post-op time point and 48-hour post-op time point. The lower the number, the better the outcome.

  4. Presence of Opiate Side Effects (Nausea, Vomiting, and Pruritus)

    Time frame: 24 hours post operavtively

    The presence of opiate side effects (nausea, vomiting, and pruritus) was evaluated from 0-24 hours post-op.

  5. Overall Patient Satisfaction With Pain Control

    Time frame: 48 hours post-op

    Patients were asked to mark their satisfaction with pain control using a Visual Analog Scale (VAS) from 0-100. The higher the number, the more satisfied they were with the post-op pain control

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Comparison of 0.1 and 0.05mg Intrathecal Morphine When Administered With a Multimodal Pain Regimen for Post-cesarean Analgesia

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Feb 9, 2018
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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