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Not yet recruiting NCT06570343

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

Phase IV Interventional Intraoperative Pain

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: Fentanyl-Morphine, Morphine.
Who it may be relevant to
Registry conditions: Intraoperative Pain. Basic parameters: 19 years — 99 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
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug Fentanyl-Morphine
    Intrathecal injection of bupivacaine, fentanyl and morphine
  • Drug Morphine
    Intrathecal injection of bupivacaine and morphine

Primary outcome measures

  • Incidence of intraoperative pain [Time frame: From first skin incision to end of surgery]
Secondary outcome measures (12)
  • Time of occurence of intraoperative pain [Time frame: From first skin incision to end of surgery]
  • Incidence of intraoperative rescue analgesic administration [Time frame: From first skin incision to end of surgery]
  • Total amount of intraoperative opioid rescue analgesic administration [Time frame: From first skin incision to end of surgery]
  • Total amount of intraoperative non-opioid rescue analgesic administration [Time frame: From first skin incision to end of surgery]
  • Intraoperative pain characteristics [Time frame: From first skin incision to end of surgery]
  • Conversion to general anesthesia [Time frame: From first skin incision to end of surgery]
  • Preoperative anxiety [Time frame: On the day before surgery]
  • Preoperative anxiety [Time frame: On the day of surgery]
  • Total amount of postoperative opioid analgesic administered [Time frame: From end of surgery to 24 hours after end of surgery]
  • Incidence of intraoperative nausea/vomiting [Time frame: From induction to end of surgery]
  • Incidence of postoperative nausea/vomiting [Time frame: From end of surgery to 24h post-surgery]
  • Incidence of intraoperative shivering [Time frame: From induction to end of surgery]

Eligibility criteria

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

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
Triple blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06570343 · 2407-091-1553

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗