Trial Outcomes & Findings for Prolonged Popliteal Fossa Nerve Blockade (Prolonged Pop) (NCT NCT02198235)

NCT ID: NCT02198235

Last Updated: 2017-06-15

Results Overview

Pain with movement at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 90 participants
• Primary outcome timeframe: 24 hours after the popliteal block is given
• Results posted on: 2017-06-15

Participant Flow

Participant milestones

Measure	Control Nerve Block + IV Dexamethasone IV Dexamethasone (4 mg) Dexamethasone	Control Nerve Block + IV Dexamethasone + IV Buprenorphine IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg) Dexamethasone Buprenorphine	Nerve Block With Dexamethasone + Buprenorphine in Block. Dexamethasone (4 mg) Buprenorphine (150 mcg) Dexamethasone Buprenorphine
Overall Study STARTED	30	30	30
Overall Study COMPLETED	27	28	28
Overall Study NOT COMPLETED	3	2	2

Reasons for withdrawal

Measure	Control Nerve Block + IV Dexamethasone IV Dexamethasone (4 mg) Dexamethasone	Control Nerve Block + IV Dexamethasone + IV Buprenorphine IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg) Dexamethasone Buprenorphine	Nerve Block With Dexamethasone + Buprenorphine in Block. Dexamethasone (4 mg) Buprenorphine (150 mcg) Dexamethasone Buprenorphine
Overall Study Lost to Follow-up	3	2	2

Baseline Characteristics

Prolonged Popliteal Fossa Nerve Blockade (Prolonged Pop)

Baseline characteristics by cohort

Measure	Control Nerve Block + IV Dexamethasone n=30 Participants IV Dexamethasone (4 mg) Dexamethasone	Control Nerve Block + IV Dexamethasone + IV Buprenorphine n=30 Participants IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg) Dexamethasone Buprenorphine	Nerve Block With Dexamethasone + Buprenorphine in Block. n=30 Participants Dexamethasone (4 mg) Buprenorphine (150 mcg) Dexamethasone Buprenorphine	Total n=90 Participants Total of all reporting groups
Age, Continuous	51.2 years STANDARD_DEVIATION 15.9 • n=5 Participants	51.1 years STANDARD_DEVIATION 15.3 • n=7 Participants	52.8 years STANDARD_DEVIATION 14.2 • n=5 Participants	51.7 years STANDARD_DEVIATION 15 • n=4 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	18 Participants n=7 Participants	17 Participants n=5 Participants	51 Participants n=4 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	12 Participants n=7 Participants	13 Participants n=5 Participants	39 Participants n=4 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	30 participants n=5 Participants	90 participants n=4 Participants
BMI (Body Mass Index)	27.2 kg/m^2 STANDARD_DEVIATION 5.68 • n=5 Participants	26.3 kg/m^2 STANDARD_DEVIATION 4.37 • n=7 Participants	26.3 kg/m^2 STANDARD_DEVIATION 5.16 • n=5 Participants	26.6 kg/m^2 STANDARD_DEVIATION 5.05 • n=4 Participants

PRIMARY outcome

Timeframe: 24 hours after the popliteal block is given

Pain with movement at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)

Outcome measures

Measure	Control Nerve Block + IV Dexamethasone n=27 Participants IV Dexamethasone (4 mg) Dexamethasone	Control Nerve Block + IV Dexamethasone + IV Buprenorphine n=28 Participants IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg) Dexamethasone Buprenorphine	Nerve Block With Dexamethasone + Buprenorphine in Block. n=28 Participants Dexamethasone (4 mg) Buprenorphine (150 mcg) Dexamethasone Buprenorphine
Numeric Rating Scale (NRS) Pain Score With Movement	1.9 units on a scale Standard Deviation 2.6	1 units on a scale Standard Deviation 1.6	1.3 units on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: 24 hours and 48 hours after the popliteal block is given

When did the nerve block entirely wear off?

Outcome measures

Measure	Control Nerve Block + IV Dexamethasone n=27 Participants IV Dexamethasone (4 mg) Dexamethasone	Control Nerve Block + IV Dexamethasone + IV Buprenorphine n=28 Participants IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg) Dexamethasone Buprenorphine	Nerve Block With Dexamethasone + Buprenorphine in Block. n=28 Participants Dexamethasone (4 mg) Buprenorphine (150 mcg) Dexamethasone Buprenorphine
Block Duration	30 hours Interval 24.1 to 45.2	37.9 hours Interval 30.7 to 43.9	45.6 hours Interval 33.9 to 53.8

SECONDARY outcome

Timeframe: 24 hours after the popliteal block is given

Pain at rest at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)

Outcome measures

Measure	Control Nerve Block + IV Dexamethasone n=27 Participants IV Dexamethasone (4 mg) Dexamethasone	Control Nerve Block + IV Dexamethasone + IV Buprenorphine n=28 Participants IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg) Dexamethasone Buprenorphine	Nerve Block With Dexamethasone + Buprenorphine in Block. n=28 Participants Dexamethasone (4 mg) Buprenorphine (150 mcg) Dexamethasone Buprenorphine
Numeric Rating Scale (NRS) Pain Score at Rest	1.8 units on a scale Standard Error 2.5	.9 units on a scale Standard Error 1.3	.8 units on a scale Standard Error 1.6

SECONDARY outcome

Timeframe: 24 hours after the popliteal block is given

Did patient have pain requiring oral opioids?

Outcome measures

Measure	Control Nerve Block + IV Dexamethasone n=27 Participants IV Dexamethasone (4 mg) Dexamethasone	Control Nerve Block + IV Dexamethasone + IV Buprenorphine n=28 Participants IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg) Dexamethasone Buprenorphine	Nerve Block With Dexamethasone + Buprenorphine in Block. n=28 Participants Dexamethasone (4 mg) Buprenorphine (150 mcg) Dexamethasone Buprenorphine
Median Time to Requiring Oral Opioids	25.5 hours Interval 18.0 to 34.7	30 hours Interval 26.8 to 40.5	35.3 hours Interval 30.3 to 55.8

Adverse Events

Control Nerve Block + IV Dexamethasone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Nerve Block + IV Dexamethasone + IV Buprenorphine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nerve Block With Dexamethasone + Buprenorphine in Block.

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. Jacques YaDeau

Hospital for Special Surgery

Phone: 212-606-1206

Email: yadeauj@hss.edu

Results disclosure agreements

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