Trial Outcomes & Findings for Evaluation of the Duration of Bupivacaine Spinal Block in Orthopedic Procedures With and Without Epinephrine Wash (NCT NCT02619409)

NCT ID: NCT02619409

Last Updated: 2023-06-06

Results Overview

Duration of the sensory block at the T12 dermatome will be assessed in the post operative phase

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

12 hours

Results posted on

2023-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	Bupivacaine Only The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc. Bupivacaine Only: The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc.	EPI25 Group The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc. EPI25: The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc.	EPI50 Group The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc. EPI50 group: The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc	EPI75 Group The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075 cc, and sterile saline 0.025%. EPI75 group: The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075cc, and sterile saline 0.025%.	EPI100 Group The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc EPI100 group: The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc.
Overall Study STARTED	6	6	6	6	6
Overall Study COMPLETED	6	6	6	6	6
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Duration of Bupivacaine Spinal Block in Orthopedic Procedures With and Without Epinephrine Wash

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bupivacaine Only n=6 Participants The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc. Bupivacaine Only: The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc.	EPI25 Group n=6 Participants The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc. EPI25: The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc.	EPI50 Group n=6 Participants The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc. EPI50 group: The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc	EPI75 Group n=6 Participants The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075 cc, and sterile saline 0.025%. EPI75 group: The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075cc, and sterile saline 0.025%.	EPI100 Group n=6 Participants The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc EPI100 group: The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc.	Total n=30 Participants Total of all reporting groups
Age, Continuous	70 years n=5 Participants	63 years n=7 Participants	58 years n=5 Participants	67 years n=4 Participants	59 years n=21 Participants	64 years n=8 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants	20 Participants n=8 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	1 Participants n=21 Participants	10 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	7 Participants n=8 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants	22 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants

PRIMARY outcome

Timeframe: 12 hours

Duration of the sensory block at the T12 dermatome will be assessed in the post operative phase

Outcome measures

Outcome measures
Measure	Bupivacaine Only n=6 Participants The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc. Bupivacaine Only: The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc.	EPI25 Group n=6 Participants The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc. EPI25: The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc.	EPI50 Group n=6 Participants The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc. EPI50 group: The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc	EPI75 Group n=6 Participants The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075 cc, and sterile saline 0.025%. EPI75 group: The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075cc, and sterile saline 0.025%.	EPI100 Group n=6 Participants The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc EPI100 group: The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc.
Duration of Sensory Block	3.41 hours Standard Deviation 1.37	2.81 hours Standard Deviation 0.42	3.23 hours Standard Deviation 0.72	3.12 hours Standard Deviation 0.61	3.22 hours Standard Deviation 1.02

PRIMARY outcome

Timeframe: 12 hours

(hip felxion) of the non operative leg