Trial Outcomes & Findings for Bupivacaine With Epidural Volume Extension (NCT NCT03110003)

Results Overview

Time from entrance into the PACU until PACU discharge criteria met

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

45 participants

Primary outcome timeframe

Baseline up to 48 hrs postoperatively

Results posted on

2018-12-19

Participant Flow

Participant milestones

Participant milestones
Measure	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	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.
Overall Study STARTED	21	24
Overall Study COMPLETED	21	24
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	10 mg Bupivacaine n=21 Participants 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	5 mg Bupivacaine n=24 Participants 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.	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=21 Participants	0 Participants n=24 Participants	0 Participants n=45 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=21 Participants	24 Participants n=24 Participants	45 Participants n=45 Participants
Age, Categorical >=65 years	0 Participants n=21 Participants	0 Participants n=24 Participants	0 Participants n=45 Participants
Sex: Female, Male Female	21 Participants n=21 Participants	24 Participants n=24 Participants	45 Participants n=45 Participants
Sex: Female, Male Male	0 Participants n=21 Participants	0 Participants n=24 Participants	0 Participants n=45 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	21 Participants n=21 Participants	24 Participants n=24 Participants	45 Participants n=45 Participants

PRIMARY outcome

Timeframe: Baseline up to 48 hrs postoperatively

Time from entrance into the PACU until PACU discharge criteria met

Outcome measures

Outcome measures
Measure	10 mg Bupivacaine n=21 Participants 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	5 mg Bupivacaine n=24 Participants 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.
Time Until PACU Discharge in Minutes	135 minutes Interval 103.0 to 182.5	50 minutes Interval 42.0 to 57.5

SECONDARY outcome

Timeframe: Baseline up to 3 hours

Population: Thoracic dermatome level as assessed by pinprick

Thoracic dermatome level as assessed by pinprick

Outcome measures

Outcome measures
Measure	10 mg Bupivacaine n=21 Participants 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	5 mg Bupivacaine n=24 Participants 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.
Peak Block Height	5 Thoracic dermatome Interval 4.0 to 7.5	5 Thoracic dermatome Interval 3.25 to 7.75

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	10 mg Bupivacaine n=21 Participants 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	5 mg Bupivacaine n=24 Participants 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.
Degree of Peak Motor Blockade by Modified Bromage Scale	3 score on a scale Interval 3.0 to 4.0	3 score on a scale Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: Baseline up to 6 hours

Population: Time elapsed until motor block regresses to modified Bromage = 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.

Outcome measures

Outcome measures
Measure	10 mg Bupivacaine n=21 Participants 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	5 mg Bupivacaine n=24 Participants 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.
Time Elapsed Until Motor Block Regresses to Modified Bromage Score = 0	181 Minutes Interval 141.0 to 225.5	66 Minutes Interval 44.5 to 87.0

SECONDARY outcome

Timeframe: Baseline up to 6 hours

Population: Quality of Block as determined by subjective pain assessment was not collected by the investigators.

Determined by any pain reported during surgery and/or the need to supplement through the epidural

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 6 hrs postoperatively

Population: Patient satisfaction as determined by a Likert-type scale was not collected by the investigators.

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.

Outcome measures

Outcome data not reported

Adverse Events

10 mg Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

5 mg Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mark Powell

University of Alabama at Birmingham

Phone: 205-975-3328

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place