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Pain | Epidural Morphine Versus Epidural Fentanyl Infusion Following Cesarean Section

Pain research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - Patients having an elective Cesarean section - Healthy women (ASA I or II) - Regional anesthesia candidates Exclusion Criteria: - Morbid obesity (BMI>40) - Sleep apnea - Age under 18 - Intolerance or addiction to opioids

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Preservative free morphine3mg given epidurally during the Cesarean section.

Drug:FentanylAn 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

Fentanyl infusionThis 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.

Study Status

Unknown status

Start Date: March 2011

Completed Date: June 2012

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Postsurgical pain

Secondary Outcome: Nausea

Study sponsors, principal investigator, and references

Principal Investigator: Evan Goodman, MD

Lead Sponsor: Goodman, Evan, M.D.

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01362998

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.

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