Clinical trial NCT06570343: Analgesic Efficacy of Intrathecal Fentanyl-Morphine Combination Versus Morphine Alone for Intraoperative Pain During Elective Cesarean Delivery
Official title: Analgesic Efficacy of Intrathecal Fentanyl-Morphine Combination Versus Morphine Alone for Intraoperative Pain During Elective Cesarean Delivery: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Intraoperative Pain
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 186
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


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

Primary outcomes:
measure: Incidence of intraoperative pain
timeFrame: From first skin incision to end of surgery
Secondary outcomes:
measure: Time of occurence of intraoperative pain
timeFrame: From first skin incision to end of surgery
measure: Incidence of intraoperative rescue analgesic administration
timeFrame: From first skin incision to end of surgery
measure: Total amount of intraoperative opioid rescue analgesic administration
timeFrame: From first skin incision to end of surgery
measure: Total amount of intraoperative non-opioid rescue analgesic administration
timeFrame: From first skin incision to end of surgery
measure: Intraoperative pain characteristics
timeFrame: From first skin incision to end of surgery
measure: Conversion to general anesthesia
timeFrame: From first skin incision to end of surgery
measure: Preoperative anxiety
timeFrame: On the day before surgery
measure: Preoperative anxiety
timeFrame: On the day of surgery
measure: Total amount of postoperative opioid analgesic administered
timeFrame: From end of surgery to 24 hours after end of surgery
measure: Incidence of intraoperative nausea/vomiting
timeFrame: From induction to end of surgery
measure: Incidence of postoperative nausea/vomiting
timeFrame: From end of surgery to 24h post-surgery
measure: Incidence of intraoperative shivering
timeFrame: From induction to end of surgery
measure: Incidence of intraoperative hypotension
timeFrame: From induction to end of surgery
measure: Incidence of intraoperative pruritus
timeFrame: From induction to end of surgery
measure: Incidence of postoperative pruritus
timeFrame: From end of surgery to 24h post-surgery
measure: Immediate post-operative patient satisfaction
timeFrame: At the end of surgery
measure: Obstetric Quality of Recovery-11K score
timeFrame: At 24 hours post-surgery
measure: Time of first postoperative pain
timeFrame: From end of surgery to 24 hours post-surgery
measure: Pain score at 8 hours post-surgery
timeFrame: at 8 hours post-surgery
measure: Pain score at 16 hours post-surgery
timeFrame: at 16 hours post-surgery
measure: Pain score at 24 hours post-surgery
timeFrame: at 24 hours post-surgery
measure: Pain score at 2 hours post-surgery
timeFrame: at 2 hours post-surgery
measure: Incidence of postoperative hypotension
timeFrame: From end of surgery to 24 hours post-surgery
measure: Incidence of postoperative shivering
timeFrame: From end of surgery to 24 hours post-surgery
measure: 24-hour post-operative patient satisfaction
timeFrame: at 24 hours post-surgery
Other outcomes:
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