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

September 29, 2024 updated by: Jin-Tae Kim, Seoul National University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
186

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of intraoperative pain
Time Frame: From first skin incision to end of surgery
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time of occurence of intraoperative pain
Time Frame: From first skin incision to end of surgery
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
Time Frame: 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
Time Frame: From first skin incision to end of surgery
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
Time Frame: From first skin incision to end of surgery
Total amount of intraoperative non-opioid rescue analgesic administration (mg)
From first skin incision to end of surgery
Intraoperative pain characteristics
Time Frame: From first skin incision to end of surgery
Intraoperative pain characteristics
From first skin incision to end of surgery
Conversion to general anesthesia
Time Frame: From first skin incision to end of surgery
Conversion to general anesthesia
From first skin incision to end of surgery
Preoperative anxiety
Time Frame: On the day before surgery
Preoperative anxiety (APAIS, Amsterdam Preoperative Anxiety and Information Score)
On the day before surgery
Preoperative anxiety
Time Frame: On the day of surgery
Preoperative anxiety (APAIS, Amsterdam Preoperative Anxiety and Information Score)
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
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
Time Frame: From induction to end of surgery
Incidence of intraoperative nausea/vomiting
From induction to end of surgery
Incidence of postoperative nausea/vomiting
Time Frame: From end of surgery to 24h post-surgery
Incidence of postoperative nausea/vomiting
From end of surgery to 24h post-surgery
Incidence of intraoperative shivering
Time Frame: From induction to end of surgery
Incidence of intraoperative shivering
From induction to end of surgery
Incidence of intraoperative hypotension
Time Frame: From induction to end of surgery
Incidence of intraoperative hypotension (MBP<65 mmHg)
From induction to end of surgery
Incidence of intraoperative pruritus
Time Frame: From induction to end of surgery
Incidence of intraoperative pruritus
From induction to end of surgery
Incidence of postoperative pruritus
Time Frame: From end of surgery to 24h post-surgery
Incidence of postoperative pruritus
From end of surgery to 24h post-surgery
Immediate post-operative patient satisfaction
Time Frame: At the end of surgery
Immediate post-operative patient satisfaction on intraoperative analgesia
At the end of surgery
Obstetric Quality of Recovery-11K score
Time Frame: At 24 hours post-surgery
Obstetric Quality of Recovery-11K score
At 24 hours post-surgery
Time of first postoperative pain
Time Frame: From end of surgery to 24 hours post-surgery
Time of first postoperative pain
From end of surgery to 24 hours post-surgery
Pain score at 8 hours post-surgery
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: From end of surgery to 24 hours post-surgery
Incidence of postoperative hypotension (MBP<65 mmHg)
From end of surgery to 24 hours post-surgery
Incidence of postoperative shivering
Time Frame: From end of surgery to 24 hours post-surgery
Incidence of postoperative shivering
From end of surgery to 24 hours post-surgery
24-hour post-operative patient satisfaction
Time Frame: at 24 hours post-surgery
24-hour post-operative patient satisfaction on postoperative analgesia
at 24 hours post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 25, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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