Clinical trial NCT03110003: Bupivacaine With Epidural Volume Extension
Official title: Comparing Low-dose Bupivacaine With Epidural Volume Extension to Standard Bupivacaine Dosing for Short Obstetric Procedures: A Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spinal Anesthesia
Epidural; Anesthesia
Keywords: Neuraxial epidural techniques
Combined spinal epidural
Epidural volume extension
Transient Neurologic Symptoms (TNS)
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Time Until PACU Discharge in Minutes
timeFrame: Baseline up to 48 hrs postoperatively
Secondary outcomes:
measure: Peak Block Height
timeFrame: Baseline up to 3 hours
measure: Degree of Peak Motor Blockade by Modified Bromage Scale
timeFrame: Baseline up to 3 hours
measure: Time Elapsed Until Motor Block Regresses to Modified Bromage Score = 0
timeFrame: Baseline up to 6 hours
measure: Quality of Block as Determined by Subjective Pain Assessment
timeFrame: Baseline up to 6 hours
measure: Patient Satisfaction as Determined by a Likert-type Scale
timeFrame: At 6 hrs postoperatively
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Department of Anesthesiology and Perioperative Medicine
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Mark Powell, MD
role: PRINCIPAL_INVESTIGATOR
References: