PainNCT01362998
Epidural Morphine Versus Epidural Fentanyl Infusion Following Cesarean Section
A study testing Preservative free morphine and Fentanyl in people with Pain, run by Goodman, Evan, M.D. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Preservative free morphine and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients having an elective Cesarean section
- Healthy women (ASA I or II)
- Regional anesthesia candidates
Who cannot join
- Morbid obesity (BMI>40)
- Sleep apnea
- Age under 18
- Intolerance or addiction to opioids
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: A Comparison of Single Dose Preservative Free Morphine With Fentanyl Infusion for Post-Cesarean Section Analgesia
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.
Read the detailed 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preservative free morphineDrug
Also called Duramorph
3mg given epidurally during the Cesarean section.
FentanylDrug
Also called PCA 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.
| Study group | Role | What they receive |
|---|---|---|
| Preservative free morphine | Active comparator | This group will receive 3mg of preservative free morphine epidurally during the procedure. Receives: 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. Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The patient will be asked whether she has nausea or vomiting (yes=1, no=0).
Measured: At 8, 24, 36 and 48 hours after the Cesarean section
Patient Satisfaction
Participants will be asked to rate their satisfaction on a 10 point Numerical Rating Scale (0=worst, 10=best).
Measured: At 8, 24, 48 and 36 hours after Cesarean section
Number of Participants Who Responded Yes to Having Back Pain
Participants will be asked whether they have back pain (Yes=1, No=0)
Measured: At 8, 24, 36 and 48 hours after the Cesarean section
Number of Participants Who Responded Yes to Having Pruritis
Participants will be asked whether they have pruritis (Yes=1, No=0)
Measured: At 8, 24, 36 and 48 hours after Cesarean section
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)
Measured: At 8, 24, 36 and 48 hours after Cesarean section
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)
Measured: At 8, 24, 36 and 48 hours after the Cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2011
- Study completionJun 2012
Why it stopped: Lack of time and help to continue the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goodman, Evan, M.D.
- Responsible party
- Principal investigator, Dr. Evan Goodman, MD, Goodman, Evan, M.D.
- Investigators
- Evan Goodman, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362998
- Sponsor's protocol ID
- goodman-2
- Status last verified
- Oct 2022
- First submitted
- 27 May 2011
- Last updated
- 14 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 12145067
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Single Dose Preservative Free Morphine With Fentanyl Infusion for Post-Cesarean Section Analgesia
- ClinicalTrials.gov ID
- NCT01362998
- Acronym / sponsor ID
- goodman-2
- Conditions
- Pain
- Keywords
- fentanyl, morphine, duramorph, Cesarean section, epidural
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of time and help to continue the study
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Goodman, Evan, M.D.
- Study start
- Jan 2011 (actual)
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 1 Jun 2011 (estimated)
- Results
- Posted 14 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preservative free morphine | Active comparator | Drug: Preservative free morphineThis group will receive 3mg of preservative free morphine epidurally during the procedure. |
| Fentanyl infusion | Active comparator | Drug: FentanylThis 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients having an elective Cesarean section
- Healthy women (ASA I or II)
- Regional anesthesia candidates
Key exclusion criteria (4 listed)
- Morbid obesity (BMI>40)
- Sleep apnea
- Age under 18
- Intolerance or addiction to opioids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preservative free morphineAlso: Duramorph3mg given epidurally during the Cesarean section. | Drug | Preservative free morphine |
| FentanylAlso: PCA 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. | Drug | Fentanyl infusion |
Primary outcome
Postsurgical Pain
Time frame: At 8, 24 36 and 48 hours after the Cesarean section
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.
6 secondary outcomes
Number of Participants Who Responded Yes to Having Nausea or Vomiting
Time frame: At 8, 24, 36 and 48 hours after the Cesarean section
Patient Satisfaction
Time frame: At 8, 24, 48 and 36 hours after Cesarean section
Number of Participants Who Responded Yes to Having Back Pain
Time frame: At 8, 24, 36 and 48 hours after the Cesarean section
Number of Participants Who Responded Yes to Having Pruritis
Time frame: At 8, 24, 36 and 48 hours after Cesarean section
Number of Participants Who Were Observed by Their Nurse to Have Urinary Retention
Time frame: At 8, 24, 36 and 48 hours after Cesarean section
Number of Participants Who Were Observed by Their Nurse to Have Respiratory Depression
Time frame: At 8, 24, 36 and 48 hours after the Cesarean section
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12145067Sarvela 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evan Goodman, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preservative free morphine and Fentanyl in people with Pain, run by Goodman, Evan, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postsurgical Pain (time frame: At 8, 24 36 and 48 hours after the Cesarean section). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01362998, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022; AzTrials last refreshed its copy on 26 Oct 2026.