Pain
Conditions
Keywords
fentanyl, morphine, duramorph, Cesarean section, epidural
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.
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.
Interventions
3mg given epidurally during the Cesarean section.
DRUGFentanyl
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.
Sponsors
Goodman, Evan, M.D.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postsurgical Pain | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Responded Yes to Having Nausea or Vomiting | At 8, 24, 36 and 48 hours after the Cesarean section | The patient will be asked whether she has nausea or vomiting (yes=1, no=0). |
| Patient Satisfaction | At 8, 24, 48 and 36 hours after Cesarean section | Participants will be asked to rate their satisfaction on a 10 point Numerical Rating Scale (0=worst, 10=best). |
| Number of Participants Who Responded Yes to Having Back Pain | At 8, 24, 36 and 48 hours after the Cesarean section | Participants will be asked whether they have back pain (Yes=1, No=0) |
| Number of Participants Who Were Observed by Their Nurse to Have Urinary Retention | At 8, 24, 36 and 48 hours after Cesarean section | Participant's nurse will be asked whether \>400ml was obtained by straight cath (Y=1, No=0) |
| Number of Participants Who Were Observed by Their Nurse to Have Respiratory Depression | At 8, 24, 36 and 48 hours after the Cesarean section | Participant's chart will be examined to determine whether the respiratory rate was \<8 per minute (Yes=1, No=0) |
| Number of Participants Who Responded Yes to Having Pruritis | At 8, 24, 36 and 48 hours after Cesarean section | Participants will be asked whether they have pruritis (Yes=1, No=0) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Required Additional Pain Medications | At 8, 24, 36 and 48 hours after the Cesarean section | Participant's nurse will be asked whether the patient required additional pain medications (Yes=1, No=0) |
Countries
United States
Participant flow
Recruitment details
2 people were recruited for this study, but data was collected for only one of them.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 0 |
| 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. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Fentanyl Infusion | Total | Preservative Free Morphine |
|---|---|---|---|
| Age, Continuous | 27 Years | 27 Years | — |
| Gestational age, continuous | 39 Weeks | 39 Weeks | — |
| Pregnancies, integer | 4 Number of pregnancies | 4 Number of pregnancies | — |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Weight, continuous | 179 pounds | 179 pounds | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 1 |
| other Total, other adverse events | 0 / 0 | 0 / 1 |
| serious Total, serious adverse events | 0 / 0 | 0 / 1 |
Outcome results
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.
Time frame: At 8, 24 36 and 48 hours after the Cesarean section
Population: No participants in morphine arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fentanyl Infusion | Postsurgical Pain | 8 hours post Cesarean section | 3 Units on a 10 point scale |
| Fentanyl Infusion | Postsurgical Pain | 24 hours post Cesarean | 0 Units on a 10 point scale |
| Fentanyl Infusion | Postsurgical Pain | 36 hours post Cesarean | 3 Units on a 10 point scale |
| Fentanyl Infusion | Postsurgical Pain | 48 hours post Cesarean | 7 Units on a 10 point scale |
Secondary
Number of Participants Who Responded Yes to Having Back Pain
Participants will be asked whether they have back pain (Yes=1, No=0)
Time frame: At 8, 24, 36 and 48 hours after the Cesarean section
Population: No participants in the morphine arm.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fentanyl Infusion | Number of Participants Who Responded Yes to Having Back Pain | 8 hours after the surgery | 0 Participants |
| Fentanyl Infusion | Number of Participants Who Responded Yes to Having Back Pain | 24 hours after the surgery | 0 Participants |
| Fentanyl Infusion | Number of Participants Who Responded Yes to Having Back Pain | 36 hours after the surgery | 0 Participants |
| Fentanyl Infusion | Number of Participants Who Responded Yes to Having Back Pain | 48 hours after the surgery | 0 Participants |
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).
Time frame: At 8, 24, 36 and 48 hours after the Cesarean section
Population: No patients were in the morphine group
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fentanyl Infusion | Number of Participants Who Responded Yes to Having Nausea or Vomiting | 8 hours after the surgery | 0 Participants |
| Fentanyl Infusion | Number of Participants Who Responded Yes to Having Nausea or Vomiting | 24 hours after the surgery | 0 Participants |
| Fentanyl Infusion | Number of Participants Who Responded Yes to Having Nausea or Vomiting | 36 hours after the surgery | 0 Participants |
| Fentanyl Infusion | Number of Participants Who Responded Yes to Having Nausea or Vomiting | 48 hours after the surgery | 0 Participants |
Secondary
Number of Participants Who Responded Yes to Having Pruritis
Participants will be asked whether they have pruritis (Yes=1, No=0)
Time frame: At 8, 24, 36 and 48 hours after Cesarean section
Population: No participants in the morphine arm.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fentanyl Infusion | Number of Participants Who Responded Yes to Having Pruritis | 48 hours after the surgery | 1 Participants |
| Fentanyl Infusion | Number of Participants Who Responded Yes to Having Pruritis | 8 hours after the surgery | 1 Participants |
| Fentanyl Infusion | Number of Participants Who Responded Yes to Having Pruritis | 24 hours after the surgery | 1 Participants |
| Fentanyl Infusion | Number of Participants Who Responded Yes to Having Pruritis | 36 hours after the surgery | 1 Participants |
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)
Time frame: At 8, 24, 36 and 48 hours after the Cesarean section
Population: No participants in morphine arm.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fentanyl Infusion | Number of Participants Who Were Observed by Their Nurse to Have Respiratory Depression | 8 hours after the surgery | 0 Participants |
| Fentanyl Infusion | Number of Participants Who Were Observed by Their Nurse to Have Respiratory Depression | 24 hours after the surgery | 0 Participants |
| Fentanyl Infusion | Number of Participants Who Were Observed by Their Nurse to Have Respiratory Depression | 36 hours after the surgery | 0 Participants |
| Fentanyl Infusion | Number of Participants Who Were Observed by Their Nurse to Have Respiratory Depression | 48 hours after the surgery | 0 Participants |
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)
Time frame: At 8, 24, 36 and 48 hours after Cesarean section
Population: No participants in morphine arm
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fentanyl Infusion | Number of Participants Who Were Observed by Their Nurse to Have Urinary Retention | 8 hours after the surgery | 0 Participants |
| Fentanyl Infusion | Number of Participants Who Were Observed by Their Nurse to Have Urinary Retention | 24 hours after the surgery | 0 Participants |
| Fentanyl Infusion | Number of Participants Who Were Observed by Their Nurse to Have Urinary Retention | 36 hours after the surgery | 0 Participants |
| Fentanyl Infusion | Number of Participants Who Were Observed by Their Nurse to Have Urinary Retention | 48 hours after the surgery | 0 Participants |
Secondary
Patient Satisfaction
Participants will be asked to rate their satisfaction on a 10 point Numerical Rating Scale (0=worst, 10=best).
Time frame: At 8, 24, 48 and 36 hours after Cesarean section
Population: There were no participants in the morphine arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fentanyl Infusion | Patient Satisfaction | 8 hours after the surgery | 10 score on a scale |
| Fentanyl Infusion | Patient Satisfaction | 24 hours after the surgery | 10 score on a scale |
| Fentanyl Infusion | Patient Satisfaction | 36 hours after the surgery | 10 score on a scale |
| Fentanyl Infusion | Patient Satisfaction | 48 hours after the surgery | 10 score on a scale |
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)
Time frame: At 8, 24, 36 and 48 hours after the Cesarean section
Population: No participants in morphine arm.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fentanyl Infusion | Number of Participants Who Required Additional Pain Medications | 8 hours after the surgery | 0 Participants |
| Fentanyl Infusion | Number of Participants Who Required Additional Pain Medications | 24 hours after the surgery | 0 Participants |
| Fentanyl Infusion | Number of Participants Who Required Additional Pain Medications | 36 hours after the surgery | 0 Participants |
| Fentanyl Infusion | Number of Participants Who Required Additional Pain Medications | 48 hours after the surgery | 1 Participants |