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

NCT06570343 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2407-091-1553
• Study Type: interventional
• Target: 186
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intraoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (25)

• Time of occurence of intraoperative pain

  From first skin incision to end of surgery

• Incidence of intraoperative rescue analgesic administration

  From first skin incision to end of surgery

• Total amount of intraoperative opioid rescue analgesic administration

  From first skin incision to end of surgery

• Total amount of intraoperative non-opioid rescue analgesic administration

  From first skin incision to end of surgery

• Intraoperative pain characteristics

  From first skin incision to end of surgery

Study Arms (2)

Fentanyl-Morphine

EXPERIMENTAL

Spinal anesthesia with heavy bupivacaine, fentanyl and morphine

Drug: Fentanyl-Morphine

Morphine

ACTIVE COMPARATOR

Spinal anesthesia with heavy bupivacaine and morphine

Drug: Morphine

Interventions

Fentanyl-Morphine DRUG

Intrathecal injection of bupivacaine, fentanyl and morphine

Fentanyl-Morphine

Morphine DRUG

Intrathecal injection of bupivacaine and morphine

Morphine

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

MeSH Terms

Interventions

Morphine

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

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

CONTACT

+82-2-2072-2467; jintae73@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 26, 2024
• Study Start: September 20, 2024
• Primary Completion: September 20, 2025
• Study Completion: December 25, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share