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NCT Number: NCT06570343

Analgesic Efficacy of Intrathecal Fentanyl-Morphine Combination Versus Morphine Alone for Intraoperative Pain During Elective Cesarean Delivery

Pregnant women scheduled for elective cesarean sections under spinal anesthesia are randomly assigned to two groups: 1) the Fentanyl-Morphine (FM) group, and 2) the Morphine (M) group. In addition to 11.5 mg of bupivacaine, the FM group receives 15 μg of fentanyl and 50 μg of morphine intrathecally, while the M group receives 50 μg of morphine intrathecally. The incidence of intraoperative pain with a Numerical Rating Scale (NRS) score of 4 or higher is compared between the two groups to evaluate the analgesic effects of combined intrathecal fentanyl-morphine therapy versus morphine alone.

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Key information

Conditions

Intraoperative Pain

Age range

19 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Parturients of gestational age > 37 weeks, scheduled for cesarean section under spinal anesthesia

Exclusion criteria

  • Contraindication to spinal anesthesia
  • Any sign of onset of labor
  • Emergency cesarean section
  • Body weight < 40 kg or > 120 kg
  • Height < 140 cm or > 190 cm
  • Severe underlying cardiovascular disease
  • Known fetal anomaly
  • Preeclampsia
  • History of hypersensitivity to fentanyl or morphine
  • Chronic opioid use

Treatment and study plan

Fentanyl-Morphine

Drug

Intrathecal injection of bupivacaine, fentanyl and morphine

Morphine

Drug

Intrathecal injection of bupivacaine and morphine

Primary outcomes

  1. Incidence of intraoperative pain

    Time frame: From first skin incision to end of surgery

    Incidence of intraoperative pain of NRS (numeric rating scale) score of 4 or higher

Secondary outcomes

  1. Time of occurence of intraoperative pain

    Time frame: From first skin incision to end of surgery

    Time of occurence of intraoperative pain of NRS (numeric rating scale) score of 4 or higher

  2. Incidence of intraoperative rescue analgesic administration

    Time frame: From first skin incision to end of surgery

    Incidence of intraoperative rescue analgesic administration

  3. Total amount of intraoperative opioid rescue analgesic administration

    Time frame: From first skin incision to end of surgery

    Total amount of intraoperative opioid rescue analgesic administration (morphine mg equivalent)

  4. Total amount of intraoperative non-opioid rescue analgesic administration

    Time frame: From first skin incision to end of surgery

    Total amount of intraoperative non-opioid rescue analgesic administration (mg)

  5. Intraoperative pain characteristics

    Time frame: From first skin incision to end of surgery

    Intraoperative pain characteristics

  6. Conversion to general anesthesia

    Time frame: From first skin incision to end of surgery

    Conversion to general anesthesia

  7. Preoperative anxiety

    Time frame: On the day before surgery

    Preoperative anxiety (APAIS, Amsterdam Preoperative Anxiety and Information Score)

  8. Preoperative anxiety

    Time frame: On the day of surgery

    Preoperative anxiety (APAIS, Amsterdam Preoperative Anxiety and Information Score)

  9. Total amount of postoperative opioid analgesic administered

    Time frame: From end of surgery to 24 hours after end of surgery

    Total amount of postoperative opioid analgesic administered (morphine mg equivalent)

  10. Incidence of intraoperative nausea/vomiting

    Time frame: From induction to end of surgery

    Incidence of intraoperative nausea/vomiting

  11. Incidence of postoperative nausea/vomiting

    Time frame: From end of surgery to 24h post-surgery

    Incidence of postoperative nausea/vomiting

  12. Incidence of intraoperative shivering

    Time frame: From induction to end of surgery

    Incidence of intraoperative shivering

  13. Incidence of intraoperative hypotension

    Time frame: From induction to end of surgery

    Incidence of intraoperative hypotension (MBP<65 mmHg)

  14. Incidence of intraoperative pruritus

    Time frame: From induction to end of surgery

    Incidence of intraoperative pruritus

  15. Incidence of postoperative pruritus

    Time frame: From end of surgery to 24h post-surgery

    Incidence of postoperative pruritus

  16. Immediate post-operative patient satisfaction

    Time frame: At the end of surgery

    Immediate post-operative patient satisfaction on intraoperative analgesia

  17. Obstetric Quality of Recovery-11K score

    Time frame: At 24 hours post-surgery

    Obstetric Quality of Recovery-11K score

  18. Time of first postoperative pain

    Time frame: From end of surgery to 24 hours post-surgery

    Time of first postoperative pain

  19. Pain score at 8 hours post-surgery

    Time frame: at 8 hours post-surgery

    Pain score at 8 hours post-surgery (NRS, numeric rating scale pain score, 0: no pain; 10: worst imaginable pain)

  20. Pain score at 16 hours post-surgery

    Time frame: at 16 hours post-surgery

    Pain score at 16 hours post-surgery (NRS, numeric rating scale pain score, 0: no pain; 10: worst imaginable pain)

  21. Pain score at 24 hours post-surgery

    Time frame: at 24 hours post-surgery

    Pain score at 24 hours post-surgery (NRS, numeric rating scale pain score, 0: no pain; 10: worst imaginable pain)

  22. Pain score at 2 hours post-surgery

    Time frame: at 2 hours post-surgery

    Pain score at 2 hours post-surgery (NRS, numeric rating scale pain score, 0: no pain; 10: worst imaginable pain)

  23. Incidence of postoperative hypotension

    Time frame: From end of surgery to 24 hours post-surgery

    Incidence of postoperative hypotension (MBP&lt;65 mmHg)

  24. Incidence of postoperative shivering

    Time frame: From end of surgery to 24 hours post-surgery

    Incidence of postoperative shivering

  25. 24-hour post-operative patient satisfaction

    Time frame: at 24 hours post-surgery

    24-hour post-operative patient satisfaction on postoperative analgesia

Study contacts

Contact information is provided by the study sponsor or research team.

Jin-Tae Kim, M.D., Ph.D

CONTACT

[email protected]

+82-2-2072-2467

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Analgesic Efficacy of Intrathecal Fentanyl-Morphine Combination Versus Morphine Alone for Intraoperative Pain During Elective Cesarean Delivery: a Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 26, 2024
Registry last updated
Oct 1, 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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