Comparing Low-dose Bupivacaine With Epidural Volume Extension to Standard Bupivacaine Dosing for Short Obstetric Procedures: A Prospective, Randomized Study
Overview
- Phase
- Phase 3
- Intervention
- 10 mg Bupivacaine
- Conditions
- Spinal Anesthesia
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Time Until PACU Discharge in Minutes
- Status
- Completed
- Last Updated
- 7 years ago
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.
Investigators
Mark Powell
Assistant Professor
University of Alabama at Birmingham
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
Arms & Interventions
10 mg Bupivacaine
Subjects will receive 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl.
Intervention: 10 mg Bupivacaine
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.
Intervention: 5 mg Bupivacaine
Outcomes
Primary Outcomes
Time Until PACU Discharge in Minutes
Time Frame: Baseline up to 48 hrs postoperatively
Time from entrance into the PACU until PACU discharge criteria met
Secondary Outcomes
- Patient Satisfaction as Determined by a Likert-type Scale(At 6 hrs postoperatively)
- Peak Block Height(Baseline up to 3 hours)
- Degree of Peak Motor Blockade by Modified Bromage Scale(Baseline up to 3 hours)
- Time Elapsed Until Motor Block Regresses to Modified Bromage Score = 0(Baseline up to 6 hours)
- Quality of Block as Determined by Subjective Pain Assessment(Baseline up to 6 hours)