Epidural Morphine Versus Epidural Fentanyl Infusion Following Cesarean Section

Pain Clinical Trial

Official title:

A Comparison of Single Dose Preservative Free Morphine With Fentanyl Infusion for Post-Cesarean Section Analgesia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01362998
• Other study ID #: goodman-2
• Status: Terminated
• Phase: N/A
• Start date: January 2011
• Est. completion date: June 2012

Study information

• Verified date: October 2022
• Source: Goodman, Evan, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Included in the study will be all healthy (ASA I or II) woman having elective Cesarean sections who are candidates for regional anesthesia. Exclusion criteria include morbid obesity (BMI > 40), age less that 18 years, history of sleep apnea, and abuse of or intolerance to opioid analgesics.

All patients will also receive 100 micrograms of fentanyl once epidurally during the Cesarean section, and they will receive ibuprofen every six hours for the first 24 hours after the Cesarean section. The patients will be visited twice a day postoperatively for two days. The epidural morphine will be expected to last only approximately 20 hours, while the fentanyl infusion will be kept in place for two days after the procedure. Additional analgesics, such as intravenous morphine or PO oxycodone and tylenol, will be available for breakthrough pain.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Preservative free morphine
3mg given epidurally during the Cesarean section.
• Fentanyl
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.

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Goodman, Evan, M.D.

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Who Required Additional Pain Medications	Participant's nurse will be asked whether the patient required additional pain medications (Yes=1, No=0)	At 8, 24, 36 and 48 hours after the Cesarean section
Primary	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	Number of Participants Who Responded Yes to Having Nausea or Vomiting	The patient will be asked whether she has nausea or vomiting (yes=1, no=0).	At 8, 24, 36 and 48 hours after the Cesarean section
Secondary	Patient Satisfaction	Participants will be asked to rate their satisfaction on a 10 point Numerical Rating Scale (0=worst, 10=best).	At 8, 24, 48 and 36 hours after Cesarean section
Secondary	Number of Participants Who Responded Yes to Having Back Pain	Participants will be asked whether they have back pain (Yes=1, No=0)	At 8, 24, 36 and 48 hours after the Cesarean section
Secondary	Number of Participants Who Responded Yes to Having Pruritis	Participants will be asked whether they have pruritis (Yes=1, No=0)	At 8, 24, 36 and 48 hours after Cesarean section
Secondary	Number of Participants Who Were Observed by Their Nurse to Have Urinary Retention	Participant's nurse will be asked whether >400ml was obtained by straight cath (Y=1, No=0)	At 8, 24, 36 and 48 hours after Cesarean section
Secondary	Number of Participants Who Were Observed by Their Nurse to Have Respiratory Depression	Participant's chart will be examined to determine whether the respiratory rate was <8 per minute (Yes=1, No=0)	At 8, 24, 36 and 48 hours after the Cesarean section