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

Phase 4

Not yet recruiting

• Conditions: Intraoperative Pain
• Interventions: Drug: Morphine; Drug: Fentanyl-Morphine

• Registration Number: NCT06570343
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-21
• Study First Submitted QC: 2024-08-22
• Study First Posted: 2024-08-26
• Study Start: 2024-09-20
• Last Update Submitted: 2024-09-29
• Last Update Posted: 2024-10-01
• Primary Completion: 2025-09-20
• Study Completion: 2025-12-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 186

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Morphine	Morphine	Spinal anesthesia with heavy bupivacaine and morphine
Fentanyl-Morphine	Fentanyl-Morphine	Spinal anesthesia with heavy bupivacaine, fentanyl and morphine

Primary Outcome Measures

Name	Time	Method
Incidence of intraoperative pain	From first skin incision to end of surgery	Incidence of intraoperative pain of NRS (numeric rating scale) score of 4 or higher

Secondary Outcome Measures

Name	Time	Method
Time of occurence of intraoperative pain	From first skin incision to end of surgery	Time of occurence of intraoperative pain of NRS (numeric rating scale) score of 4 or higher
Incidence of intraoperative rescue analgesic administration	From first skin incision to end of surgery	Incidence of intraoperative rescue analgesic administration
Incidence of postoperative hypotension	From end of surgery to 24 hours post-surgery	Incidence of postoperative hypotension (MBP\<65 mmHg)
Incidence of postoperative shivering	From end of surgery to 24 hours post-surgery	Incidence of postoperative shivering
24-hour post-operative patient satisfaction	at 24 hours post-surgery	24-hour post-operative patient satisfaction on postoperative analgesia
Total amount of intraoperative opioid rescue analgesic administration	From first skin incision to end of surgery	Total amount of intraoperative opioid rescue analgesic administration (morphine mg equivalent)
Total amount of intraoperative non-opioid rescue analgesic administration	From first skin incision to end of surgery	Total amount of intraoperative non-opioid rescue analgesic administration (mg)
Intraoperative pain characteristics	From first skin incision to end of surgery	Intraoperative pain characteristics
Conversion to general anesthesia	From first skin incision to end of surgery	Conversion to general anesthesia
Preoperative anxiety	On the day of surgery	Preoperative anxiety (APAIS, Amsterdam Preoperative Anxiety and Information Score)
Total amount of postoperative opioid analgesic administered	From end of surgery to 24 hours after end of surgery	Total amount of postoperative opioid analgesic administered (morphine mg equivalent)
Incidence of intraoperative nausea/vomiting	From induction to end of surgery	Incidence of intraoperative nausea/vomiting
Incidence of postoperative nausea/vomiting	From end of surgery to 24h post-surgery	Incidence of postoperative nausea/vomiting
Incidence of intraoperative shivering	From induction to end of surgery	Incidence of intraoperative shivering
Incidence of intraoperative hypotension	From induction to end of surgery	Incidence of intraoperative hypotension (MBP\<65 mmHg)
Incidence of intraoperative pruritus	From induction to end of surgery	Incidence of intraoperative pruritus
Incidence of postoperative pruritus	From end of surgery to 24h post-surgery	Incidence of postoperative pruritus
Immediate post-operative patient satisfaction	At the end of surgery	Immediate post-operative patient satisfaction on intraoperative analgesia
Obstetric Quality of Recovery-11K score	At 24 hours post-surgery	Obstetric Quality of Recovery-11K score
Time of first postoperative pain	From end of surgery to 24 hours post-surgery	Time of first postoperative pain
Pain score at 8 hours post-surgery	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)
Pain score at 16 hours post-surgery	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)
Pain score at 24 hours post-surgery	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)
Pain score at 2 hours post-surgery	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)