Bupivacaine With Epidural Volume Extension

• ClinicalTrials.gov Identifier: NCT03110003
• Recruitment Status: Completed
• First Posted: April 12, 2017
• Results First Posted: September 13, 2018
• Last Update Posted: December 19, 2018
• Sponsor: University of Alabama at Birmingham
• Information provided by (Responsible Party): Mark Powell, University of Alabama at Birmingham

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Spinal Anesthesia; Epidural; Anesthesia	Drug: 10 mg Bupivacaine; Drug: 5 mg Bupivacaine	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Comparing Low-dose Bupivacaine With Epidural Volume Extension to Standard Bupivacaine Dosing for Short Obstetric Procedures: A Prospective, Randomized Study
• Actual Study Start Date: June 27, 2016
• Actual Primary Completion Date: December 1, 2017
• Actual Study Completion Date: September 30, 2018

Arms and Interventions

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 Name: 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 Name: Marcaine and Sensorcaine

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Peak Block Height [ Time Frame: Baseline up to 3 hours ]
   Thoracic dermatome level as assessed by pinprick
2. Degree of Peak Motor Blockade by Modified Bromage Scale [ Time Frame: Baseline up to 3 hours ]

   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.

3. Time Elapsed Until Motor Block Regresses to Modified Bromage Score = 0 [ Time Frame: Baseline up to 6 hours ]

   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.

4. Quality of Block as Determined by Subjective Pain Assessment [ Time Frame: Baseline up to 6 hours ]
   Determined by any pain reported during surgery and/or the need to supplement through the epidural
5. Patient Satisfaction as Determined by a Likert-type Scale [ Time Frame: At 6 hrs postoperatively ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Alabama

UAB Department of Anesthesiology and Perioperative Medicine

Birmingham, Alabama, United States, 35249

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

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

  Study Documents (Full-Text)

Documents provided by Mark Powell, University of Alabama at Birmingham:

Study Protocol and Statistical Analysis Plan  [PDF] March 25, 2016

More Information

• Responsible Party: Mark Powell, Assistant Professor, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03110003
• Other Study ID Numbers: F1605020005
• First Posted: April 12, 2017
• Results First Posted: September 13, 2018
• Last Update Posted: December 19, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Mark Powell, University of Alabama at Birmingham:

Neuraxial epidural techniques; Combined spinal epidural; Epidural volume extension; Transient Neurologic Symptoms (TNS)

Additional relevant MeSH terms:

Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents