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Determination of the Effective Volume of 0.125% Bupivacaine-fentanyl 5mcg/mL in Labour Epidurals

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ClinicalTrials.gov Identifier: NCT01972269
Recruitment Status : Completed
First Posted : October 30, 2013
Last Update Posted : June 4, 2014
Sponsor:
Information provided by (Responsible Party):
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Brief Summary:

Different medications can be used as analgesics in labor epidurals. Bupivacaine is one of the most commonly used drugs for that purpose. The efficacy of a certain medication injected epidurally depends on the dose that is given. A certain dose can be administered in different concentrations, which will consequently mean different volumes. Studies have been done to determine volumes for different concentrations of bupivacaine. However, those studies fall short in the sense that this information cannot be readily applicable in clinical practice, as we don't use bupivacaine plain. The combination of bupivacaine and fentanyl or sufentanil is common practice, as it is well established that the opioids will reduce the concentration of local anesthetic required to produce optimal effect with the least side effects.

This study is being planned to determine and compare the EV90 of the bupivacaine 0.125%-fentanyl mixture for initiation of labor epidural analgesia, following the administration of the 2 different test doses (3cc of lidocaine 2% or 3cc of the bupivacaine 0.125%-fentanyl mixture) used in our Department.


Condition or disease Intervention/treatment Phase
Pain Drug: Bupivacaine-fentanyl Drug: Lidocaine Not Applicable

Detailed Description:

Epidural administration of local anesthetics during labor produces analgesia, sympathetic block and motor block. The characteristics of the block depend on the volume and concentration of the local anesthetic that is used as well as the use of adjuncts(in our case: Fentanyl). Although many researchers have investigated the efficacy of different drugs at different concentrations, the volumes used have been arbitrary. There is limited data regarding the minimum volume that is necessary for a successful anesthetic for a given concentration of bupivacaine.

This study is conducted as a prospective, randomized, up-down sequential allocation trial. The aim is to determine the minimum volume of 0.125% bupivacaine in combination with 5mcgr/ml fentanyl that will provide effective analgesia for 90% of parturients in the first stage of labor. The verbal numeric rating scale (VNRS) is used to rate the pain felt over the first 20 minutes, where 0 is no pain and 10 is the worst pain imaginable. After 20 minutes, if the VNRS was greater than 1, the volume of the bupivacaine/fentanyl mixture was considered inadequate and additional volume of the mixture will be given.

After the randomised test dose of either 3cc lidocaine 2% or 3cc of the bupivacaine/fentanyl mixture is given, the loading volume of the bupivacaine/fentanyl mixture will be given. The volume of the bupivacaine/fentanyl mixture for the first patient was chosen at 10 ml (This is the volume with which is generally started in standard practice), and the dose for each subsequent patient depends on the outcome of the previous injection. Doses will be increased or decreased in increments of 2 ml. If the previous response was ineffective, the next patient will receive 2 ml more than the last patient. If the response of the previous patient is effective, the biased coin up-and-down allocation design, which is used to cluster doses around EV90, will be applied to determine if the dose remains the same or decreases.

40 patients will be included in each group within the study. The target volume, EV90, which is defined as the volume at which adequate response would occur in 90% of patients, will be estimated for each of the two test dose groups using Dixon and Mood method. The 95% confidence interval of EV90s will be estimated and based in comparing the EV90 between two groups. Isotonic Regression method will also be conducted to assess the EV90s. The side effects will also be summarized by the volume levels descriptively.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Determination of the Effective Volume of the 0.125% Bupivacaine-fentanyl 5mcg/mL Mixture Used for Epidural Analgesia in Labor
Study Start Date : October 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: bupivacaine-fentanyl 4
Test dose: 3mL of 0.125% bupivacaine-fentanyl 5mcg/mL. Loading dose: 4mL of 0.125% bupivacaine-fentanyl 5mcg/mL.
Drug: Bupivacaine-fentanyl
0.125% bupivacaine-fentanyl 5mcg/mL
Other Name: Marcaine

Active Comparator: bupivacaine-fentanyl 6
Test dose: 3mL of 0.125% bupivacaine-fentanyl 5mcg/mL. Loading dose: 6mL of 0.125% bupivacaine-fentanyl 5mcg/mL.
Drug: Bupivacaine-fentanyl
0.125% bupivacaine-fentanyl 5mcg/mL
Other Name: Marcaine

Active Comparator: bupivacaine-fentanyl 8
Test dose: 3mL of 0.125% bupivacaine-fentanyl 5mcg/mL. Loading dose: 8mL of 0.125% bupivacaine-fentanyl 5mcg/mL.
Drug: Bupivacaine-fentanyl
0.125% bupivacaine-fentanyl 5mcg/mL
Other Name: Marcaine

Active Comparator: bupivacaine-fentanyl 10
Test dose: 3mL of 0.125% bupivacaine-fentanyl 5mcg/mL. Loading dose: 10mL of 0.125% bupivacaine-fentanyl 5mcg/mL.
Drug: Bupivacaine-fentanyl
0.125% bupivacaine-fentanyl 5mcg/mL
Other Name: Marcaine

Active Comparator: bupivacaine-fentanyl 12
Test dose: 3mL of 0.125% bupivacaine-fentanyl 5mcg/mL. Loading dose: 12mL of 0.125% bupivacaine-fentanyl 5mcg/mL.
Drug: Bupivacaine-fentanyl
0.125% bupivacaine-fentanyl 5mcg/mL
Other Name: Marcaine

Active Comparator: bupivacaine-fentanyl 14
Test dose: 3mL of 0.125% bupivacaine-fentanyl 5mcg/mL. Loading dose: 14mL of 0.125% bupivacaine-fentanyl 5mcg/mL.
Drug: Bupivacaine-fentanyl
0.125% bupivacaine-fentanyl 5mcg/mL
Other Name: Marcaine

Active Comparator: bupivacaine-fentanyl 16
Test dose: 3mL of 0.125% bupivacaine-fentanyl 5mcg/mL. Loading dose: 16mL of 0.125% bupivacaine-fentanyl 5mcg/mL.
Drug: Bupivacaine-fentanyl
0.125% bupivacaine-fentanyl 5mcg/mL
Other Name: Marcaine

Active Comparator: lidocaine 4
Test dose: 3mL of 2% lidocaine. Loading dose: 4mL of 0.125% bupivacaine-fentanyl 5mcg/mL.
Drug: Bupivacaine-fentanyl
0.125% bupivacaine-fentanyl 5mcg/mL
Other Name: Marcaine

Drug: Lidocaine
2% lidocaine

Active Comparator: lidocaine 6
Test dose: 3mL of 2% lidocaine. Loading dose: 6mL of 0.125% bupivacaine-fentanyl 5mcg/mL.
Drug: Bupivacaine-fentanyl
0.125% bupivacaine-fentanyl 5mcg/mL
Other Name: Marcaine

Drug: Lidocaine
2% lidocaine

Active Comparator: lidocaine 8
Test dose: 3mL of 2% lidocaine. Loading dose: 8mL of 0.125% bupivacaine-fentanyl 5mcg/mL.
Drug: Bupivacaine-fentanyl
0.125% bupivacaine-fentanyl 5mcg/mL
Other Name: Marcaine

Drug: Lidocaine
2% lidocaine

Active Comparator: lidocaine 10
Test dose: 3mL of 2% lidocaine. Loading dose: 10mL of 0.125% bupivacaine-fentanyl 5mcg/mL.
Drug: Bupivacaine-fentanyl
0.125% bupivacaine-fentanyl 5mcg/mL
Other Name: Marcaine

Drug: Lidocaine
2% lidocaine

Active Comparator: lidocaine 12
Test dose: 3mL of 2% lidocaine. Loading dose: 12mL of 0.125% bupivacaine-fentanyl 5mcg/mL.
Drug: Bupivacaine-fentanyl
0.125% bupivacaine-fentanyl 5mcg/mL
Other Name: Marcaine

Drug: Lidocaine
2% lidocaine

Active Comparator: lidocaine 14
Test dose: 3mL of 2% lidocaine. Loading dose: 14mL of 0.125% bupivacaine-fentanyl 5mcg/mL
Drug: Bupivacaine-fentanyl
0.125% bupivacaine-fentanyl 5mcg/mL
Other Name: Marcaine

Drug: Lidocaine
2% lidocaine

Active Comparator: lidocaine 16
Test dose: 3mL of 2% lidocaine. Loading dose: 16mL of 0.125% bupivacaine-fentanyl 5mcg/mL
Drug: Bupivacaine-fentanyl
0.125% bupivacaine-fentanyl 5mcg/mL
Other Name: Marcaine

Drug: Lidocaine
2% lidocaine




Primary Outcome Measures :
  1. VNRS pain score [ Time Frame: 20 minutes ]
    The efficacy of the loading dose will be defined as a pain score ≤ 1 at 20 minutes following injection of the loading dose.


Secondary Outcome Measures :
  1. Dermatome sensory level [ Time Frame: 20 min ]
    Dermatome sensory level measured using ice

  2. Motor block [ Time Frame: 20 min ]
    Measured by modified Bromage score; 0 = no impairment, 1 = unable to raise the extended leg but able to move/flex knees and feet, 2 = unable to raise extended leg or flex knees, but able to move foot, 3 = unable to flex ankle, feet or knees).

  3. Hypotension [ Time Frame: 20 min ]
    Hypotension, defined as a drop in systolic blood pressure greater than 20% from baseline values.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ASA I or II
  • Full term (minimum 37 weeks gestation)
  • Singleton pregnancy, vertex presentation
  • Regular painful contractions occurring at least every 5 minutes
  • VAS Pain score at requesting analgesia > 5 (VNPS 0-10)
  • Cervical dilatation < 5 cm

Exclusion Criteria:

  • Refusal to provide written informed consent.
  • Any contraindication to epidural anesthesia
  • Accidental dural puncture
  • Allergy or hypersensitivity to bupivacaine or fentanyl
  • Use of opioids or sedatives within the last 4 hours.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972269


Locations
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Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
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Principal Investigator: Jose CA Carvalho, MD MOUNT SINAI HOSPITAL

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Responsible Party: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01972269     History of Changes
Other Study ID Numbers: 13-06
13-0247-A ( Other Identifier: Research Ethics Board )
First Posted: October 30, 2013    Key Record Dates
Last Update Posted: June 4, 2014
Last Verified: June 2014

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Epidural
Labor Analgesia
Bupivacaine
Minimum effective volume

Additional relevant MeSH terms:
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Bupivacaine
Lidocaine
Fentanyl
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General