Trial Outcomes & Findings for Effectiveness of Perineural Clonidine as an Adjuvant With Ropivacaine for Popliteal Nerve Block in Patients Undergoing Foot and Ankle Surgery (NCT NCT01986751)

Results Overview

Mean time onset of sensory block and motor block between the study group and the control group to assess the efficacy of clonidine to prolong the block duration.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

14 participants

Primary outcome timeframe

baseline to 72 hours

Results posted on

2016-11-04

Participant Flow

Participant milestones

Participant milestones
Measure	Clonidine and Ropivacaine A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Clonidine ropivacaine	Ropivacaine Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine ropivacaine
Overall Study STARTED	10	4
Overall Study COMPLETED	0	2
Overall Study NOT COMPLETED	10	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Clonidine and Ropivacaine A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Clonidine ropivacaine	Ropivacaine Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine ropivacaine
Overall Study improperly consented	10	2

Baseline Characteristics

Effectiveness of Perineural Clonidine as an Adjuvant With Ropivacaine for Popliteal Nerve Block in Patients Undergoing Foot and Ankle Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clonidine and Ropivacaine n=10 Participants A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Clonidine ropivacaine	Ropivacaine n=4 Participants Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine ropivacaine	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	4 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to 72 hours

Population: Study was prematurely terminated. No data were collected for this assessment.

Mean time onset of sensory block and motor block between the study group and the control group to assess the efficacy of clonidine to prolong the block duration.