Bupivacaine With Epidural Volume Extension

Phase 3

Completed

• Conditions: Spinal Anesthesia; Epidural; Anesthesia
• Interventions: Drug: 10 mg Bupivacaine; Drug: 5 mg Bupivacaine

• Registration Number: NCT03110003
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study Start: 2016-06-27
• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-12
• Primary Completion: 2017-12-01
• Results First Submitted: 2018-08-06
• Results First Submitted QC: 2018-08-06
• Results First Posted: 2018-09-13
• Study Completion: 2018-09-30
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-28
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

• Patients undergoing short obstetric procedure in the operating room requiring neuraxial anesthesia.

Read More

Exclusion Criteria

• coagulopathy
• platelets <80,000
• allergy to local anesthetic or fentanyl
• previous spinal surgery
• spinal or intracranial mass
• history of lower extremity weakness

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10 mg Bupivacaine	10 mg Bupivacaine	Subjects will receive 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl.
5 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.

Primary Outcome Measures

Name	Time	Method
Time Until PACU Discharge in Minutes	Baseline up to 48 hrs postoperatively	Time from entrance into the PACU until PACU discharge criteria met

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction as Determined by a Likert-type Scale	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.
Peak Block Height	Baseline up to 3 hours	Thoracic dermatome level as assessed by pinprick
Degree of Peak Motor Blockade by Modified Bromage Scale	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.
Time Elapsed Until Motor Block Regresses to Modified Bromage Score = 0	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.
Quality of Block as Determined by Subjective Pain Assessment	Baseline up to 6 hours	Determined by any pain reported during surgery and/or the need to supplement through the epidural

Trial Locations

Locations (1)

UAB Department of Anesthesiology and Perioperative Medicine; 🇺🇸 Birmingham, Alabama, United States