Bupivacaine With Epidural Volume Extension

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Comparing Low-dose Bupivacaine With Epidural Volume Extension to Standard Bupivacaine Dosing for Short Obstetric Procedures: A Prospective, Randomized Study

Conditions
-----------------
Spinal Anesthesia, Epidural; Anesthesia

Intervention / Treatment
-----------------
* Drug: 10 mg Bupivacaine
* Drug: 5 mg Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 10 mg Bupivacaine<br>Subjects will receive 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl. | Drug: 10 mg Bupivacaine<br>* 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space<br>* Other names: Marcaine and Sensorcaine;|
| Active Comparator: 5 mg Bupivacaine<br>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. | Drug: 5 mg Bupivacaine<br>* 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.<br>* Other names: Marcaine and Sensorcaine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Until PACU Discharge in Minutes | Time from entrance into the PACU until PACU discharge criteria met | Baseline up to 48 hrs postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Block Height | Thoracic dermatome level as assessed by pinprick | Baseline up to 3 hours | 
| Degree of Peak Motor Blockade by Modified Bromage Scale | Motor blockade will be determined by the patient's ability to lift her legs This is simple scale used to assess motor function in the patients' legs. A numerical value from 0 to 4 is assigned to visual inspection of how well the patient can move her legs. 0=ability to maintain a leg lift for prolonged periods; 1=ability to lift legs briefly; 2=ability to bend knees; 3=ability to wiggle toes; 4=no movement in legs. A score of 0 means complete movement (no blockade) in the legs, whereas a score of 4 means no movement (complete blockade) in the legs. | Baseline up to 3 hours | 
| Time Elapsed Until Motor Block Regresses to Modified Bromage Score = 0 | Time until score of <2 reached on Modified Bromage scale This is simple scale used to assess motor function in the patients' legs. A numerical value from 0 to 4 is assigned to visual inspection of how well the patient can move her legs. 0=ability to maintain a leg lift for prolonged periods; 1=ability to lift legs briefly; 2=ability to bend knees; 3=ability to wiggle toes; 4=no movement in legs. A score of 0 means complete movement (no blockade) in the legs, whereas a score of 4 means no movement (complete blockade) in the legs. Once the patient received as score of 0, the time ended. Again, 0=ability to maintain a leg lift for prolonged periods. | Baseline up to 6 hours | 
| Quality of Block as Determined by Subjective Pain Assessment | Determined by any pain reported during surgery and/or the need to supplement through the epidural | Baseline up to 6 hours | 
| Patient Satisfaction as Determined by a Likert-type Scale | Patient satisfaction of a scale of 1-10 This scale is grade from 1 to 10 with 1 being highly dissatisfied with the anesthetic technique and 10 being highly satisfied. Each patient was asked to rate their experience with the anesthetic technique provide. They could choose any number between 1 and 10. Numbers close to 10 represented a higher satisfaction with the anesthetic technique. | At 6 hrs postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neuraxial epidural techniques, Combined spinal epidural, Epidural volume extension, Transient Neurologic Symptoms (TNS)