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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intraoperative Pain
• Intervention / Treatment: Drug: Fentanyl-Morphine; Drug: Morphine

• Study Type: Interventional
• Enrollment (Estimated): 186
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jin-Tae Kim, M.D., Ph.D; Phone Number: +82-2-2072-2467; Email: jintae73@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fentanyl-Morphine; Spinal anesthesia with heavy bupivacaine, fentanyl and morphine	Drug: Fentanyl-Morphine; Intrathecal injection of bupivacaine, fentanyl and morphine
Active Comparator: Morphine; Spinal anesthesia with heavy bupivacaine and morphine	Drug: Morphine; Intrathecal injection of bupivacaine and morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of intraoperative pain	Incidence of intraoperative pain of NRS (numeric rating scale) score of 4 or higher	From first skin incision to end of surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 20, 2024
• Primary Completion (Estimated): September 20, 2025
• Study Completion (Estimated): December 25, 2025

Study Registration Dates

• First Submitted: August 21, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 29, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl; Morphine
• Other Study ID Numbers: 2407-091-1553

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No