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Lack of time and help to continue the study
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preservative free morphine | Active Comparator | This group will receive 3mg of preservative free morphine epidurally during the procedure. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preservative free morphine | Drug | 3mg given epidurally during the Cesarean section. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Patient Satisfaction |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evan Goodman, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12145067 | Background | 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. |
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2 people were recruited for this study, but data was collected for only one of them.
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| ID | Title | Description |
|---|---|---|
| FG000 | Preservative Free Morphine | This group will receive 3mg of preservative free morphine epidurally during the procedure. Preservative free morphine: 3mg given epidurally during the Cesarean section. |
| FG001 | Fentanyl Infusion | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Note that no people were recruited for the morphine arm. Note that 2 people were recruited for the fentanyl arm, but that data was collected for only 1 person.
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| ID | Title | Description |
|---|---|---|
| BG000 | Preservative Free Morphine | This group will receive 3mg of preservative free morphine epidurally during the procedure. Preservative free morphine: 3mg given epidurally during the Cesarean section. |
| BG001 | Fentanyl Infusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | No participants in morphine arm. | Posted | Number | Units on a 10 point scale | At 8, 24 36 and 48 hours after the Cesarean section |
|
6 months
Note that morphine arm has no participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Preservative Free Morphine | This group will receive 3mg of preservative free morphine epidurally during the procedure. Preservative free morphine: 3mg given epidurally during the Cesarean section. |
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Note that data was collected from only one participant in a two-armed study, so no statistical comparisons could be made.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Evan Goodman, principal investigator | University Hospitals of Cleveland | 2168445300 | evan.goodman@uhhospitals.org |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| 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. |
|
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
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.
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.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Weight, continuous | Number | pounds |
|
| Pregnancies, integer | Number | Number of pregnancies |
|
| Gestational age, continuous | Number | Weeks |
|
|
|
| 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). | No patients were in the morphine group | Posted | Count of Participants | Participants | 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). | There were no participants in the morphine arm. | Posted | Number | score on a scale | 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) | No participants in the morphine arm. | Posted | Count of Participants | Participants | 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) | No participants in the morphine arm. | Posted | Count of Participants | Participants | 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) | No participants in morphine arm | Posted | Count of Participants | Participants | 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) | No participants in morphine arm. | Posted | Count of Participants | Participants | At 8, 24, 36 and 48 hours after the Cesarean section |
|
|
|
| Other Pre-specified | 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) | No participants in morphine arm. | Posted | Count of Participants | Participants | At 8, 24, 36 and 48 hours after the Cesarean section |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Fentanyl Infusion | 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. 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. | 0 | 1 | 0 | 1 | 0 | 1 |
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| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| Title | Measurements |
|---|---|
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| 48 hours after the surgery |
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| Title | Measurements |
|---|---|
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| 48 hours after the surgery |
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| Title | Measurements |
|---|---|
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| 48 hours after the surgery |
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| Title | Measurements |
|---|---|
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| 48 hours after the surgery |
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| Title | Measurements |
|---|---|
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| 48 hours after the surgery |
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| Title | Measurements |
|---|---|
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| 48 hours after the surgery |
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| Title | Measurements |
|---|---|
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| 48 hours after the surgery |
|