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Completed

NCT Number: NCT03110003

Bupivacaine With Epidural Volume Extension

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.

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Key information

Conditions

Spinal Anesthesia Epidural; Anesthesia

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

UAB Department of Anesthesiology and Perioperative Medicine

Birmingham, Alabama, 35249, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

10 mg Bupivacaine

Drug

10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space

Other names: Marcaine and Sensorcaine

5 mg Bupivacaine

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Apr 12, 2017
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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