Scheduled Cesarean Sections, Postoperative Pain Management, Side Effects
Conditions
Keywords
postoperative pain, narcotic side effects
Brief summary
The investigators are attempting to see if eliminating the amount of long acting spinal narcotic during cesarean section delivery will demonstrate pain scores with movement when evaluated 24 hours postoperatively as those that receive the standard dosage of spinal narcotic when combined with oral acetaminophen or placebo. The investigators also are evaluating if there are decreased side effects related to decreased narcotic usage.
Detailed description
Subjects are randomized on the morning of surgery to receive a standard dose of spinal narcotic or to receive no long acting spinal narcotic. The subjects may or may not also receive acetaminophen orally postoperatively. Pain scores are done on postoperative day one as well as evaluation of potential narcotic side effects such as nausea/vomiting, itching, and sedation.
Interventions
DRUGduramorph
duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching.
DRUGplacebo
placebo in an equal volume to that of duramorph 150 mcg given with spinal anesthetic, then receipt of oral acetaminophen 1000mg during first 24 hours postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* anticipated pain level estimated to be in the lowest 20th percentile (calculated \<34.3 utilizing our standard preoperative questionnaire) * age \>/= 18 * not allergic to any study medications to be utilized in this study * singleton pregnancy
Exclusion criteria
* allergies to morphine or acetaminophen * diagnosis of a chronic pain disorder * weight \>300 lbs * hepatic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain | 24 hours | Pain assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no pain to 100 indicating the most severe pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Itching | 24 hours | The itching assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no itching to 100 indicating the most severe itching. |
| Nausea/Vomiting | 24 hours | The nausea/vomiting assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no nausea/vomiting to 100 indicating the most severe nausea/vomiting. |
Countries
United States
Participant flow
Recruitment details
Recruitment and enrollment occurred between December 2011 and September 2013. The study was terminated due to extreme difficulty in recruiting patients willing to participate in the study.
Participants by arm
| Arm | Count |
|---|---|
| Duramorph duramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours
duramorph: duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching. | 7 |
| no Duramorph no duramorph is administered spinally for surgery; subjects receive acetaminophen 1 G orally x 4 doses during first 24 hours postoperatively
placebo: placebo in an equal volume to that of duramorph 150 mcg given with spinal anesthetic, then receipt of oral acetaminophen 1000mg during first 24 hours postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching. | 6 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | pain scores at 24 hours not collected | 1 | 0 |
Baseline characteristics
| Characteristic | Duramorph | no Duramorph | Total |
|---|---|---|---|
| Age, Continuous | 32 years | 30 years | 31 years |
| estimated gestational age of fetus | 39 weeks | 39 weeks | 39 weeks |
| gravida | 3 number | 2 number | 2 number |
| height | 64.8 inches | 64.5 inches | 64.6 inches |
| para | 1 number | 1 number | 1 number |
| Region of Enrollment United States | 7 Participants | 6 Participants | 13 Participants |
| Sex/Gender, Customized female participants | 7 Participants | 6 Participants | 13 Participants |
| weight | 206 pounds | 166 pounds | 186 pounds |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 6 |
| serious Total, serious adverse events | 0 / 7 | 0 / 6 |
Outcome results
Primary
Pain
Pain assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no pain to 100 indicating the most severe pain.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duramorph | Pain | 56 units on a scale | Standard Deviation 27 |
| no Duramorph | Pain | 21 units on a scale | Standard Deviation 11 |
Secondary
Itching
The itching assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no itching to 100 indicating the most severe itching.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duramorph | Itching | 55.3 units on a scale | Standard Deviation 21.7 |
| no Duramorph | Itching | 1.3 units on a scale | Standard Deviation 3.3 |
Secondary
Nausea/Vomiting
The nausea/vomiting assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no nausea/vomiting to 100 indicating the most severe nausea/vomiting.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duramorph | Nausea/Vomiting | 37 units on a scale | Standard Deviation 38.2 |
| no Duramorph | Nausea/Vomiting | 6.2 units on a scale | Standard Deviation 15.1 |