Trial of Onset of Epidural Pain Relief With Low Dose Bupivacaine and Different Doses of Fentanyl in Laboring Women

Study Overview
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Brief Summary
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Epidural analgesia is the most effective form of labor pain relief. Low doses of local anesthetic (freezing solutions) in combination with opioids (narcotics) are commonly used as epidural solutions to provide pain relief. Low dose local anesthetic solutions with opioids for labor have been shown to decrease motor block (leg weakness or temporary paralysis), without affecting labor pain relief. However, onset of pain relief can be delayed with these low dose solutions. The standard epidural solution used at Victoria Hospital is a low dose of local anesthetic called bupivacaine mixed with fentanyl, an opioid, for labor epidural pain relief. There is some evidence that the addition of more fentanyl to the epidural bolus dose of bupivacaine at the start of labor epidural analgesia can speed onset of pain relief. Both medications are safe for you and your baby. This study will investigate whether the addition of different doses of fentanyl (20 mcg, 50 mcg and 100 mcg) to the epidural bolus dose speeds onset of pain relief. The study hypothesis is that the onset of epidural labor analgesia will be shortest with the larger fentanyl epidural bolus.

Official Title
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Onset of Labor Epidural Analgesia With Low Dose Bupivacaine and Different Doses of Fentanyl: a Randomized Double Blinded Clinical Trial.

Conditions
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Anesthetic, Sedative or Analgesic Complications in Labor or Delivery

Intervention / Treatment
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* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status 1 or 2 Pregnant women in early labor (cervical dilation <5cm) Singleton fetuses Gestational age more than 36 weeks Normal fetal heart rate tracing Exclusion Criteria: Severe pre-ecclampsia Antepartum hemorrhage ASA >3 Chronic pain Substance abuse Language barrier between patient and investigator Contraindications to epidural analgesia Allergies to local anesthetics or fentanyl Morbid obesity Previous administration of opioid analgesia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: F20<br>Patients randomized to this arm of the study receive 20 mcg fentanyl and 8 mg bupivacaine as their epidural loading dose | Drug: Fentanyl<br>* After obtaining informed consent, patients are randomized into one of two treatment groups or a control group by a computer generated random number table. After confirmation of epidural placement following test dose administration, a loading dose of 10 ml 0.08% Bupivacaine containing 20 mcg Fentanyl is administered after adding 1.6 ml 0.9% NaCl (Sodium Chloride) in the control group (F20).<br>* Other names: Duragesic, Actiq;|
| Experimental: F50<br>Patients randomized to this arm of the study receive 50 mcg fentanyl with 8 mg bupivacaine as their epidural loading dose | Drug: Fentanyl<br>* After obtaining informed consent, patients are randomized into one of two treatment groups or a control group by a computer generated random number table. After confirmation of epidural placement following test dose administration, a loading dose of 10 ml 0.08% Bupivacaine containing 20 mcg Fentanyl is administered after adding 1.6 ml 0.9% NaCl (Sodium Chloride) in the control group (F20).<br>* Other names: Duragesic, Actiq;|
| Experimental: F100<br>Patients randomized to this arm of the study receive 100 mcg fentanyl and 8 mg bupivacaine as their epidural loading dose | Drug: Fentanyl<br>* After obtaining informed consent, patients are randomized into one of two treatment groups or a control group by a computer generated random number table. After confirmation of epidural placement following test dose administration, a loading dose of 10 ml 0.08% Bupivacaine containing 20 mcg Fentanyl is administered after adding 1.6 ml 0.9% NaCl (Sodium Chloride) in the control group (F20).<br>* Other names: Duragesic, Actiq;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time, in minutes, since completion of epidural bolus to the first painless contraction | A painless contraction = verbal Numeric Pain Rating Scale less than or equal to 3/10 | Time since epidural bolus dose administration (At 1 and 5 minutes ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory block height to ice |  | 30 minutes after epidural bolus dose | 
| Pruritis | Pruritus will be measured using a 4-point scale, where 0 is none, 1 is mild, 2 is moderate, and 3 is severe. | 30 minutes after epidural bolus dose | 
| Nausea | Nausea will be measured using a 4-point scale, where 0 is none, 1 is mild, 2 is moderate, and 3 is severe. | 30 minutes after epidural bolus dose | 
| Maternal sedation | Maternal sedation will be measured using a 5-point scale where 0 is wide awake, 1 is mildly drowsy, 2 is very drowsy, 3 is asleep but rousable, and 4 is somnolent. | 30 minutes after epidural bolus dose | 
| Hypotension | Hypotension is defined as a decrease in systolic blood pressure by 30% or more, or less than 90 mmHg. It is treated with intravenous ephedrine. | 30 minutes after epidural bolus dose | 
| Motor block | Motor block will be assessed using a modified Bromage score (0 = ability to move hips, ankles, and knees, 1 = inability to raise extended leg, 2 = inability to flex knee, and 3 = inability to flex ankle, foot or knee). | 30 minutes after epidural bolus dose | 
| Time, in minutes, from epidural bolus dose to use of patient controlled epidural demand dose | time after epidural loading dose at which patient uses Patient Controlled Epidural Analgesia administered bolus | Estimated time frame 1 hour | 
| Patient satisfaction of analgesia | Patient satisfaction of analgesia will be measured using a 5-point scale where 0 is completely dissatisfied, 1 is somewhat dissatisfied, 2 is neutral, 3 is somewhat satisfied, and 4 is completely satisfied. | 30 minutes from epidural bolus dose | 
| Incidence of failed analgesia | Patients who have a verbal Numeric Rating Scale score greater than 3/10 after 30 minutes of epidural bolus dose will be deemed a failure. | 30 minutes after epidural bolus dose | 
| Incidence of fetal bradycardia |  | Estimated time frame 24 hours | 
| Time, in minutes, from completion of epidural test dose to delivery |  | Estimated time frame 24 hours | 
| Type of delivery |  | Estimated time frame 24 hours | 
| Fetal birth weight |  | Estimated time frame 24 hours | 
| Neonatal Apgar scores |  | At 1 and 5 minutes post-delivery | 
| Breastfeeding | Has breastfeeding been established at 24 hours post-delivery? | 24 hours after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Labor epidural analgesia, Fentanyl, Bupivacaine, Onset