Labor Pain
Conditions
Brief summary
This study will investigate the dose of hydromorphone which will relieve the pain of women in labor when delivered directly in the area around the spinal cord (i.e., intrathecal injection). The primary objective is to determine the dose of intrathecal hydromorphone that results in a pain score of less than 4 out of 10 thirty minutes after intrathecal injection in 50% of women. Secondary objectives include determining this dose at five and ten minutes after injection. Thirty women admitted to labor and delivery for planned vaginal delivery desiring epidural placement will be consented for the study. The starting dose of intrathecal hydromorphone will be 6 mcg. The up-and-down sequential allocation method of statistical analysis will be used, meaning that each subsequent dose will be dependent upon the result obtained from the prior dose - ergo, if the initial subject has pain relief, the second subject will receive 4 mcg (2 mcg less), but if the initial subject does not have pain relief, the second subject will receive 8 mcg (2 mcg more) of hydromorphone. After the intrathecal injection is given and the epidural is placed, visual analogue pain scores will be assessed 60 minutes following injection. A pain score of less than three will be a positive result. A pain score of three or greater will be a negative result. Blood pressure, heart rate, arterial oxygen saturation, fetal heart rate, and any side effects will also be assessed.
Interventions
DRUGHydromorphone
Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.
Sponsors
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy patients * Labor * Desires pain relief
Exclusion criteria
* Any comorbidities other than obesity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score, Visual Analogue Pain Scores | 30 minutes after intrathecal injection | Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores, Visual Analogue Pain Scale | Baseline | Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain). |
Countries
United States
Participant flow
Recruitment details
Subjects enrolled from January 2013 to November 2013
Participants by arm
| Arm | Count |
|---|---|
| Hydromorphone Laboring patients receive ED50 of hydromorphone one time intrathecally.
ED50 of hydromorphone was 12.7 mcg +/- 3.27. | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Hydromorphone |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
Primary
Pain Score, Visual Analogue Pain Scores
Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
Time frame: 30 minutes after intrathecal injection
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Hydromorphone | Pain Score, Visual Analogue Pain Scores | 1.9 units on a scale |
Secondary
Pain Scores, Visual Analogue Pain Scale
Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
Time frame: Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Hydromorphone | Pain Scores, Visual Analogue Pain Scale | 8.6 units on a scale |