Labor Pain
Conditions
Keywords
non narcotic, epidural, labor pain, Non narcotic treatment of labor pain
Brief summary
The purpose of this study is to see which dose of epidural neostigmine is the best additive to use with the numbing medication used in an epidural during labor.
Detailed description
This study is examining the use of the non-narcotic medication, neostigmine, in combination with the local anesthetic bupivacaine when compared with the commonly used narcotic fentanyl in providing pain relief with the fewest side effects in labor analgesia.
Interventions
DRUGNeostigmine
utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
DRUGBupivacaine
DRUGfentanyl
fentanyl 2 mcg/ml
Sponsors
Wake Forest University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Healthy pregnancy * Term pregnancy ( \> 37 weeks) * Primiparous or multiparous * Induction or spontaneous labor greater or = 18 years of age * Cervical exam on entry \</=5 cm
Exclusion criteria
* Weight \> 115 kg * Non-English speaking * IV analgesics within 60 minutes prior to epidural being administered * Allergy to local anesthetics or neostigmine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Drug Consumed Per Hour in Each Group(Arm) | until delivery | Median hourly total bupivacaine consumption. Drug amount consumed per hour of each group (arm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedation | until delivery | average maternal sedation score measured on a 0-not sleepy at all up to a maximum of 10-extremely sleepy |
| Shivering | until delivery | maternal occurrence of shivering--Shivering scored on a 0-no shivering at all up to maximum of 10-shivering uncontrollably |
| Pruritus | until delivery | the occurrence of pruritis (itching) throughout the labor analgesia infusion--the presence of itching rated on a scale of 0-no itching at all up to a maximum of 10- severe itching. |
| Nausea | until delivery | average maximum nausea score in each group--maternal nausea scored on a 0-no nausea at all up to maximum of 10-worst nausea imaginable |
| Patient Satisfaction Scores | within 24 hours post delivery | maternal reported satisfaction scores of labor analgesia on a scale of 1-5, with 1-not satisfied at all up to 5 -completely satisfied with labor analgesia |
| Cesarean Delivery | occurence | percentage of subjects in each group requiring a ceserean delivery |
| Bromage Score | until delivery | the incidence of decreased motor block (Bromage score) documented until delivery. Bromage is defined as 0-freely able to move extremities (no motor block) up to 3-unable to move legs or feet (complete motor block) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bupivacaine With Neostimgine 8 mcg/ml STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine | 38 |
| Bupivacaine and Neostigmine 4 mcg/ml STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine | 40 |
| Bupivacaine With Neostigmine 2 mcg/ml STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML
Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Bupivacaine | 38 |
| BUPIVACAINE WITH FENTANYL 2 MCG/ML Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION
Bupivacaine
fentanyl: fentanyl 2 mcg/ml | 35 |
| Total | 151 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | failed inclusion criteria | 3 | 3 | 1 | 2 |
| Overall Study | Lack of Efficacy | 11 | 2 | 6 | 11 |
| Overall Study | missing data | 1 | 0 | 1 | 4 |
| Overall Study | technical issue | 0 | 0 | 2 | 1 |
| Overall Study | unavailable research staff | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Bupivacaine With Neostimgine 8 mcg/ml | Bupivacaine and Neostigmine 4 mcg/ml | Bupivacaine With Neostigmine 2 mcg/ml | BUPIVACAINE WITH FENTANYL 2 MCG/ML | Total |
|---|---|---|---|---|---|
| Age, Continuous | 28 years STANDARD_DEVIATION 5 | 27 years STANDARD_DEVIATION 6 | 28 years STANDARD_DEVIATION 6 | 27 years STANDARD_DEVIATION 6 | 27.5 years STANDARD_DEVIATION 5.75 |
| Sex: Female, Male Female | 38 Participants | 40 Participants | 38 Participants | 35 Participants | 151 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 38 | 0 / 40 | 0 / 38 | 0 / 35 |
| serious Total, serious adverse events | 0 / 38 | 0 / 40 | 0 / 38 | 0 / 35 |
Outcome results
Primary
Amount of Drug Consumed Per Hour in Each Group(Arm)
Median hourly total bupivacaine consumption. Drug amount consumed per hour of each group (arm)
Time frame: until delivery
Population: median hourly total bupivacaine consumption in each group, in ml/hr
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bupivacaine With Neostimgine 8 mcg/ml | Amount of Drug Consumed Per Hour in Each Group(Arm) | 16.2 milliliters per hour |
| Bupivacaine and Neostigmine 4 mcg/ml | Amount of Drug Consumed Per Hour in Each Group(Arm) | 14.6 milliliters per hour |
| Bupivacaine With Neostigmine 2 mcg/ml | Amount of Drug Consumed Per Hour in Each Group(Arm) | 15.3 milliliters per hour |
| BUPIVACAINE WITH FENTANYL 2 MCG/ML | Amount of Drug Consumed Per Hour in Each Group(Arm) | 16 milliliters per hour |
Secondary
Bromage Score
the incidence of decreased motor block (Bromage score) documented until delivery. Bromage is defined as 0-freely able to move extremities (no motor block) up to 3-unable to move legs or feet (complete motor block)
Time frame: until delivery
Population: Bromage is defined as 0-freely able to move extremities (no motor block) up to 3-unable to move legs or feet (complete motor block)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivacaine With Neostimgine 8 mcg/ml | Bromage Score | 0.7 units on a scale | Standard Deviation 0.7 |
| Bupivacaine and Neostigmine 4 mcg/ml | Bromage Score | 1.1 units on a scale | Standard Deviation 1.4 |
| Bupivacaine With Neostigmine 2 mcg/ml | Bromage Score | 1.0 units on a scale | Standard Deviation 0.9 |
| BUPIVACAINE WITH FENTANYL 2 MCG/ML | Bromage Score | 0.9 units on a scale | Standard Deviation 1.3 |
Secondary
Cesarean Delivery
percentage of subjects in each group requiring a ceserean delivery
Time frame: occurence
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bupivacaine With Neostimgine 8 mcg/ml | Cesarean Delivery | 21 percentage of subjects in each group |
| Bupivacaine and Neostigmine 4 mcg/ml | Cesarean Delivery | 15 percentage of subjects in each group |
| Bupivacaine With Neostigmine 2 mcg/ml | Cesarean Delivery | 24 percentage of subjects in each group |
| BUPIVACAINE WITH FENTANYL 2 MCG/ML | Cesarean Delivery | 14 percentage of subjects in each group |
Secondary
Nausea
average maximum nausea score in each group--maternal nausea scored on a 0-no nausea at all up to maximum of 10-worst nausea imaginable
Time frame: until delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivacaine With Neostimgine 8 mcg/ml | Nausea | 1.3 units on a scale | Standard Deviation 2.5 |
| Bupivacaine and Neostigmine 4 mcg/ml | Nausea | 1.8 units on a scale | Standard Deviation 3 |
| Bupivacaine With Neostigmine 2 mcg/ml | Nausea | 1.8 units on a scale | Standard Deviation 3 |
| BUPIVACAINE WITH FENTANYL 2 MCG/ML | Nausea | 1.2 units on a scale | Standard Deviation 2.2 |
Secondary
Patient Satisfaction Scores
maternal reported satisfaction scores of labor analgesia on a scale of 1-5, with 1-not satisfied at all up to 5 -completely satisfied with labor analgesia
Time frame: within 24 hours post delivery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bupivacaine With Neostimgine 8 mcg/ml | Patient Satisfaction Scores | 4.5 units on a scale |
| Bupivacaine and Neostigmine 4 mcg/ml | Patient Satisfaction Scores | 4.0 units on a scale |
| Bupivacaine With Neostigmine 2 mcg/ml | Patient Satisfaction Scores | 4.0 units on a scale |
| BUPIVACAINE WITH FENTANYL 2 MCG/ML | Patient Satisfaction Scores | 4.0 units on a scale |
Secondary
Pruritus
the occurrence of pruritis (itching) throughout the labor analgesia infusion--the presence of itching rated on a scale of 0-no itching at all up to a maximum of 10- severe itching.
Time frame: until delivery
Population: the presence of itching rated on a scale of 0-no itching at all up to a maximum of 10- severe itching.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivacaine With Neostimgine 8 mcg/ml | Pruritus | 0.05 units on a scale | Standard Deviation 0.3 |
| Bupivacaine and Neostigmine 4 mcg/ml | Pruritus | 0.03 units on a scale | Standard Deviation 0.2 |
| Bupivacaine With Neostigmine 2 mcg/ml | Pruritus | 0.03 units on a scale | Standard Deviation 0.2 |
| BUPIVACAINE WITH FENTANYL 2 MCG/ML | Pruritus | 0.9 units on a scale | Standard Deviation 1.8 |
Secondary
Sedation
average maternal sedation score measured on a 0-not sleepy at all up to a maximum of 10-extremely sleepy
Time frame: until delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivacaine With Neostimgine 8 mcg/ml | Sedation | 3.3 units on a scale | Standard Deviation 3 |
| Bupivacaine and Neostigmine 4 mcg/ml | Sedation | 3.4 units on a scale | Standard Deviation 3 |
| Bupivacaine With Neostigmine 2 mcg/ml | Sedation | 3.3 units on a scale | Standard Deviation 2.9 |
| BUPIVACAINE WITH FENTANYL 2 MCG/ML | Sedation | 4.1 units on a scale | Standard Deviation 3 |
Secondary
Shivering
maternal occurrence of shivering--Shivering scored on a 0-no shivering at all up to maximum of 10-shivering uncontrollably
Time frame: until delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivacaine With Neostimgine 8 mcg/ml | Shivering | 0.2 units on a scale | Standard Deviation 0.4 |
| Bupivacaine and Neostigmine 4 mcg/ml | Shivering | 0.3 units on a scale | Standard Deviation 0.4 |
| Bupivacaine With Neostigmine 2 mcg/ml | Shivering | 0.3 units on a scale | Standard Deviation 0.5 |
| BUPIVACAINE WITH FENTANYL 2 MCG/ML | Shivering | 0.2 units on a scale | Standard Deviation 0.4 |