Trial Outcomes & Findings for Efficacy of Popliteal Nerve Blocks With and Without Dexamethasone on the Duration of Analgesia for Foot & Ankle Surgery (NCT NCT01975285)

NCT ID: NCT01975285

Last Updated: 2016-05-06

Results Overview

Postoperative pain will be measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No pain" and 10 indicates= The worst possible pain

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 60 participants
• Primary outcome timeframe: 3 days
• Results posted on: 2016-05-06

Participant Flow

Participant milestones

Measure	Dexamethasone Group 0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc	Saline Group 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc
Overall Study STARTED	30	30
Overall Study COMPLETED	28	28
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Dexamethasone Group 0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc	Saline Group 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc
Overall Study Failed Block and follow up	2	2

Baseline Characteristics

Efficacy of Popliteal Nerve Blocks With and Without Dexamethasone on the Duration of Analgesia for Foot & Ankle Surgery

Baseline characteristics by cohort

Measure	Dexamethasone Group n=28 Participants 0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc	Saline Group n=28 Participants 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc	Total n=56 Participants Total of all reporting groups
Age, Continuous	55 years STANDARD_DEVIATION 15 • n=5 Participants	55 years STANDARD_DEVIATION 14 • n=7 Participants	55 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	17 Participants n=7 Participants	36 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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 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	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants	28 participants n=7 Participants	56 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 days

Postoperative pain will be measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No pain" and 10 indicates= The worst possible pain

Outcome measures

Measure	Dexamethasone Group n=28 Participants 0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc	Saline Group n=28 Participants 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc
Postoperative Pain	0.21 Scores on a scale Standard Deviation 0.56	0.05 Scores on a scale Standard Deviation 0.22

SECONDARY outcome

Timeframe: 3 days

Opioid consumption obtained from the recorded data Perioperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts)

Outcome measures

Measure	Dexamethasone Group n=28 Participants 0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc	Saline Group n=28 Participants 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc
Opioid Consumption	0 Opioids consumption mg Standard Deviation 0	0 Opioids consumption mg Standard Deviation 0

SECONDARY outcome

Timeframe: 3 days

Time in days and/or hours

Outcome measures

Measure	Dexamethasone Group n=28 Participants 0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc	Saline Group n=28 Participants 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc
Length of Analgesia	36 Hours Interval 25.0 to 51.0	30 Hours Interval 22.5 to 41.5

SECONDARY outcome

Timeframe: 3 days

Patient satisfaction with regional nerve block: measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No satisfied at all 10 indicates= Extremely satisfied

Outcome measures

Measure	Dexamethasone Group n=28 Participants 0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc	Saline Group n=28 Participants 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc
Patient Satisfaction With Regional Nerve Block	9.6 Scores on a scale Standard Deviation 0.9	9.3 Scores on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: 3 days

Patient satisfaction with pain management: measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No satisfied at all 10 indicates= Extremely satisfied

Outcome measures

Measure	Dexamethasone Group n=28 Participants 0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc	Saline Group n=28 Participants 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc
Patient Satisfaction With Pain Management	9 Scores on a scale Standard Deviation 1.7	9.3 Scores on a scale Standard Deviation 1.4

Adverse Events

Dexamethasone Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline Group

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

Roya Yumul, M.D., Ph.D.

Department of Anesthesiology at Cedars-Sinai Medical Center in Los Angeles

Phone: 310-423-5841

Email: (Roya.Yumul@cshs.org)

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place