Bupivacaine With Epidural Volume Extension

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Anesthesia; Epidural; Anesthesia
• Intervention / Treatment: Drug: 10 mg Bupivacaine; Drug: 5 mg Bupivacaine

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • UAB Department of Anesthesiology and Perioperative Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Mark Powell, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: November 28, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Combined spinal epidural; Neuraxial epidural techniques; Epidural volume extension; Transient Neurologic Symptoms (TNS)
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: F1605020005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes