Epidural; Anesthesia, Spinal Anesthesia
Conditions
Keywords
Neuraxial epidural techniques, Combined spinal epidural, Epidural volume extension, Transient Neurologic Symptoms (TNS)
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.
Interventions
DRUG10 mg Bupivacaine
10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space
DRUG5 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.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Until PACU Discharge in Minutes | Baseline up to 48 hrs postoperatively | Time from entrance into the PACU until PACU discharge criteria met |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 10 mg Bupivacaine Subjects will receive 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl.
10 mg Bupivacaine: 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space | 21 |
| 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.
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. | 24 |
| Total | 45 |
Baseline characteristics
| Characteristic | 5 mg Bupivacaine | Total | 10 mg Bupivacaine |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 45 Participants | 21 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 24 Participants | 45 Participants | 21 Participants |
| Sex: Female, Male Female | 24 Participants | 45 Participants | 21 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 24 |
| other Total, other adverse events | 0 / 21 | 0 / 24 |
| serious Total, serious adverse events | 0 / 21 | 0 / 24 |
Outcome results
Primary
Time Until PACU Discharge in Minutes
Time from entrance into the PACU until PACU discharge criteria met
Time frame: Baseline up to 48 hrs postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 10 mg Bupivacaine | Time Until PACU Discharge in Minutes | 135 minutes |
| 5 mg Bupivacaine | Time Until PACU Discharge in Minutes | 50 minutes |
Secondary
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.
Time frame: Baseline up to 3 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 10 mg Bupivacaine | Degree of Peak Motor Blockade by Modified Bromage Scale | 3 score on a scale |
| 5 mg Bupivacaine | Degree of Peak Motor Blockade by Modified Bromage Scale | 3 score on a scale |
Secondary
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.
Time frame: At 6 hrs postoperatively
Population: Patient satisfaction as determined by a Likert-type scale was not collected by the investigators.
Secondary
Peak Block Height
Thoracic dermatome level as assessed by pinprick
Time frame: Baseline up to 3 hours
Population: Thoracic dermatome level as assessed by pinprick
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 10 mg Bupivacaine | Peak Block Height | 5 Thoracic dermatome |
| 5 mg Bupivacaine | Peak Block Height | 5 Thoracic dermatome |
Secondary
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
Time frame: Baseline up to 6 hours
Population: Quality of Block as determined by subjective pain assessment was not collected by the investigators.
Secondary
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.
Time frame: Baseline up to 6 hours
Population: Time elapsed until motor block regresses to modified Bromage = 0.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 10 mg Bupivacaine | Time Elapsed Until Motor Block Regresses to Modified Bromage Score = 0 | 181 Minutes |
| 5 mg Bupivacaine | Time Elapsed Until Motor Block Regresses to Modified Bromage Score = 0 | 66 Minutes |