Bupivacaine With Epidural Volume Extension

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-27

Study Completion Date

2018-09-30

Brief Summary

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In this study the investigator will address the efficacy of using low dose bupivacaine spinal anesthesia (SA) in combination with epidural volume extension (EVE) for patients undergoing short obstetric procedures.

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Detailed Description

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Due to risks to both the mother and fetus, neuraxial anesthesia - spinal, epidural, or combined spinal-epidural (CSE) - is preferred over general anesthesia for all obstetrical procedures. However, one downside to neuraxial anesthesia is the increased time patients have to stay in the post-anesthesia care unit (PACU) due to residual numbness from the neuraxial block. In this study, the investigators will address the efficacy of using low dose bupivacaine spinal anesthesia (SA) in combination with epidural volume extension (EVE) for patients undergoing short obstetric procedures. This will be accomplished by performing a CSE with: 1) injecting the local anesthesia in the spinal space; 2) injecting sterile saline into the epidural space to help increase the spread of the local anesthesia in the spinal space. The idea is that physicians will be able to use less local anesthetic due to getting a greater spread of medication. This lower amount of local anesthetic will lead to a decreased duration of the spinal block; therefore, it will significantly decrease PACU length of stay. This technique will be compared to our traditional dose of spinal anesthetic without EVE in the CSE. Both groups will have an epidural catheter in place to allow us to give any additional local anesthetic to keep the patient comfortable throughout the procedure if the spinal anesthesia begins to wear off. The aim of this study is to determine if low dose spinal bupivacaine in conjunction with EVE can decrease the PACU recovery time for short obstetric procedures while still providing an adequate surgical block.

Conditions

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Spinal Anesthesia Epidural; Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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10 mg Bupivacaine

Subjects will receive 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl.

Group Type ACTIVE_COMPARATOR

10 mg Bupivacaine

Intervention Type DRUG

10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space

5 mg Bupivacaine

Subjects will receive 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.

Group Type ACTIVE_COMPARATOR

5 mg Bupivacaine

Intervention Type DRUG

5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.

Interventions

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10 mg Bupivacaine

10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space

Intervention Type DRUG

5 mg Bupivacaine

5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.

Intervention Type DRUG

Other Intervention Names

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Marcaine and Sensorcaine Marcaine and Sensorcaine

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing short obstetric procedure in the operating room requiring neuraxial anesthesia.

Exclusion Criteria

* coagulopathy
* platelets \<80,000
* allergy to local anesthetic or fentanyl
* previous spinal surgery
* spinal or intracranial mass
* history of lower extremity weakness

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes