Pain, Morphine Adverse Reaction
Conditions
Keywords
Post-cesarean analgesia, Second dose of epidural morphine after surgery, Post-operative analgesia, Self-administered epidural morphine, Pain management after cesarean
Brief summary
The investigators aim to assess the analgesic effect of a two-dose epidural morphine regimen for 2nd day post-cesarean pain, as part of a multimodal analgesia regimen, which includes scheduled Nonsteroidal anti-inflammatory drugs (NSAIDs). The investigators hypothesize that administration of a second dose of epidural morphine 3 mg, 24 hours after an initial intraoperative dose, will provide superior post-cesarean analgesia during the 2nd 24 hours after surgery, compared to a single epidural morphine dose regimen. The primary outcome will be the amount of intravenous morphine patients self-administer during the 2nd 24 hours post-surgery.
Detailed description
This will be a randomized, double-blinded placebo-controlled study. In this study, women who underwent cesarean section with epidural anesthesia will receive 3 mg of epidural morphine intraoperatively, and have the epidural catheter left in place. Patients will be randomized to receive either epidural saline or epidural morphine 3 mg at 18 - 24 hours after the first dose of epidural morphine, following which the epidural catheter will be removed. It is standard of care at our institution for women undergoing cesarean section with epidural anesthesia to receive epidural morphine 3 mg. What is not typically carried out is to give a second dose of epidural morphine 3mg. The randomization will be carried out by a computerized block randomization table; the proportion for the 2 groups will be 1:1. The primary outcome will be the amount of intravenous morphine patients self-administer in the second 24 hours after surgery. Secondary outcomes will include pain scores every 6 hours, satisfaction with analgesia, side effects (itching, nausea/vomiting).
Interventions
Patients will be given 3mg epidural morphine, 24 hours after the initial dose.
DRUGEpidural Saline
Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg.
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Women undergoing cesarean section under epidural anesthesia.
Exclusion criteria
* Emergent cesarean section * Coagulopathy * Failed epidural anesthesia or patchy block * General anesthesia * Use of epidural chloroprocaine * Allergy or contraindication to Non-steroidal anti-inflammatory drug (NSAIDs) * Severe opioid side effects * History of chronic opioid use * History of chronic pain * History of obstructive sleep apnea * Morbid obesity (Body Mass Index (BMI)\>45 kg/m2) * Height under 4' 10 (147 cm) * Documented dural puncture by the epidural (Tuohy) needle * Preeclampsia * Other significant medical disease (American Society of Anesthesiologists (ASA) 3 or more).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Average Amount of Intravenous Morphine Patients Self-administered in the Second 24 Hours Post-surgery | Up to 48 hours post-operatively | The primary outcome of this study is the amount (mg) of morphine self-administered by PCA pump during the second 24 hours after surgery. This will be compared by unpaired t-test for two groups. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Epidural Morphine Group receiving 3mg epidural morphine, 24 hours after the initial dose
Epidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose. | 2 |
| Epidural Saline Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.
Epidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg. | 3 |
| Total | 5 |
Baseline characteristics
| Characteristic | Epidural Morphine | Epidural Saline | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 3 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 5 Participants |
| Region of Enrollment United States | 2 participants | 3 participants | 5 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
The Average Amount of Intravenous Morphine Patients Self-administered in the Second 24 Hours Post-surgery
The primary outcome of this study is the amount (mg) of morphine self-administered by PCA pump during the second 24 hours after surgery. This will be compared by unpaired t-test for two groups.
Time frame: Up to 48 hours post-operatively
Population: Data could not be summarized to include in the data table because only 5 out of 140 subjects were enrolled prior to study termination, and no data analysis was carried out. As instructed, we are specifying zero (0) for the Number of Participants Analyzed in each Arm/Group and leaving the data fields blank.