Epidural Morphine Versus Epidural Fentanyl Infusion Following Cesarean Section

NCT01362998 | Terminated Results DMC

• 1 other identifier: goodman-2
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

For post-Cesarean analgesia, the investigators will compare the efficacy of single-shot epidural preservative free morphine with a continuous epidural fentanyl infusion. The investigators will be comparing the patient's pain level and satisfaction with the two techniques, as well as the side effects that the patients experience, such as itching, nausea, back pain and respiratory depression.

Conditions

Pain

Keywords

fentanyl, morphine, duramorph, Cesarean section, epidural

Outcome Measures

Primary Outcomes (1)

• Postsurgical Pain

  Participants will be asked to rate their pain on a 10 point Numerical Rating Pain Scale, where zero is no pain and ten is the most intense pain possible.

  At 8, 24 36 and 48 hours after the Cesarean section

Secondary Outcomes (6)

• Number of Participants Who Responded Yes to Having Nausea or Vomiting

  At 8, 24, 36 and 48 hours after the Cesarean section

• Patient Satisfaction

  At 8, 24, 48 and 36 hours after Cesarean section

• Number of Participants Who Responded Yes to Having Back Pain

  At 8, 24, 36 and 48 hours after the Cesarean section

• Number of Participants Who Responded Yes to Having Pruritis

  At 8, 24, 36 and 48 hours after Cesarean section

• Number of Participants Who Were Observed by Their Nurse to Have Urinary Retention

  At 8, 24, 36 and 48 hours after Cesarean section

Other Outcomes (1)

• Number of Participants Who Required Additional Pain Medications

  At 8, 24, 36 and 48 hours after the Cesarean section

Study Arms (2)

Preservative free morphine

ACTIVE COMPARATOR

This group will receive 3mg of preservative free morphine epidurally during the procedure.

Drug: Preservative free morphine

Fentanyl infusion

ACTIVE COMPARATOR

This group will receive an epidural infusion of fentanyl (60 micrograms per hour), which will be started during the Cesarean section and which will continue for the next two days.

Drug: Fentanyl

Interventions

Preservative free morphine DRUG

3mg given epidurally during the Cesarean section.

Also known as: Duramorph

Preservative free morphine

Fentanyl DRUG

An infusion of epidural fentanyl started during the Cesarean section. It will be given on a patient controlled analgesia basis, with a basal rate of 60 micrograms, a demand dose of 16 micrograms, and a lockout of 15 mins.

Also known as: PCA fentanyl

Fentanyl infusion

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients having an elective Cesarean section
• Healthy women (ASA I or II)
• Regional anesthesia candidates

You may not qualify if:

• Morbid obesity (BMI\>40)
• Sleep apnea
• Age under 18
• Intolerance or addiction to opioids

Sponsors & Collaborators

• Goodman, Evan, M.D.: lead

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• Sarvela J, Halonen P, Soikkeli A, Korttila K. A double-blinded, randomized comparison of intrathecal and epidural morphine for elective cesarean delivery. Anesth Analg. 2002 Aug;95(2):436-40, table of contents. doi: 10.1097/00000539-200208000-00037.

  PMID: 12145067 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Morphine; Fentanyl

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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; Piperidines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Note that data was collected from only one participant in a two-armed study, so no statistical comparisons could be made.

Results Point of Contact

• Title: Evan Goodman, principal investigator
• Organization: University Hospitals of Cleveland

evan.goodman@uhhospitals.org

2168445300

Study Officials

• Evan Goodman, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: May 27, 2011
• First Posted: June 1, 2011
• Study Start: January 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2012
• Last Updated: November 14, 2022
• Results First Posted: November 14, 2022

Record last verified: 2022-10

Locations

US (1)