Trial Outcomes & Findings for Trial Comparing the Onset and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using Ropivacaine Versus Ropivacaine-Chloroprocaine Mixture (NCT NCT01719237)

Results Overview

Onset of surgical anesthesia is defined as the time after injection of local anesthetic to the time where no sensation of pinprick in the ulnar, median, radial and musculocutaneous nerves

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

45 minutes

Results posted on

2023-05-25

Participant Flow

Participant milestones

Participant milestones
Measure	Ropivacaine and Cholroprocaine Mixture 20 ml's of 1% ropivacaine + 10 ml's of 3% 2-chloroprocaine + 0.1 ml of 1 mg/ml epinephrine Ropivacine and Chloroprocaine mixture: Chloroprocaine is added to Ropivacaine	Ropivacaine Only 30 ml syringe with either 20 ml's of 1% ropivacaine + 10 ml's of normal saline + 0.1 ml of 1mg/ml epinephrine Ropivacaine only: Ropivacaine diluted with normal saline instead of chloroprocaine
Overall Study STARTED	30	30
Overall Study COMPLETED	30	29
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ropivacaine and Cholroprocaine Mixture 20 ml's of 1% ropivacaine + 10 ml's of 3% 2-chloroprocaine + 0.1 ml of 1 mg/ml epinephrine Ropivacine and Chloroprocaine mixture: Chloroprocaine is added to Ropivacaine	Ropivacaine Only 30 ml syringe with either 20 ml's of 1% ropivacaine + 10 ml's of normal saline + 0.1 ml of 1mg/ml epinephrine Ropivacaine only: Ropivacaine diluted with normal saline instead of chloroprocaine
Overall Study Physician Decision	0	1

Baseline Characteristics

Trial Comparing the Onset and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using Ropivacaine Versus Ropivacaine-Chloroprocaine Mixture

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ropivacaine and Cholroprocaine Mixture n=30 Participants 20 ml's of 1% ropivacaine + 10 ml's of 3% 2-chloroprocaine + 0.1 ml of 1 mg/ml epinephrine Ropivacine and Chloroprocaine mixture: Chloroprocaine is added to Ropivacaine	Ropivacaine Only n=29 Participants 30 ml syringe with either 20 ml's of 1% ropivacaine + 10 ml's of normal saline + 0.1 ml of 1mg/ml epinephrine Ropivacaine only: Ropivacaine diluted with normal saline instead of chloroprocaine	Total n=59 Participants Total of all reporting groups
Age, Continuous	50 years n=99 Participants	46 years n=107 Participants	48 years n=206 Participants
Sex: Female, Male Female	14 Participants n=99 Participants	16 Participants n=107 Participants	30 Participants n=206 Participants
Sex: Female, Male Male	16 Participants n=99 Participants	13 Participants n=107 Participants	29 Participants n=206 Participants
Region of Enrollment United States	30 participants n=99 Participants	29 participants n=107 Participants	59 participants n=206 Participants
Weight (Kg)	86.4 kilograms STANDARD_DEVIATION 20.5 • n=99 Participants	80.7 kilograms STANDARD_DEVIATION 19 • n=107 Participants	83.6 kilograms STANDARD_DEVIATION 20.0 • n=206 Participants
BMI (Kg/m^2)	30.2 kg/m^2 STANDARD_DEVIATION 8.7 • n=99 Participants	28.0 kg/m^2 STANDARD_DEVIATION 5.7 • n=107 Participants	29.1 kg/m^2 STANDARD_DEVIATION 7.5 • n=206 Participants

PRIMARY outcome

Timeframe: 45 minutes

Onset of surgical anesthesia is defined as the time after injection of local anesthetic to the time where no sensation of pinprick in the ulnar, median, radial and musculocutaneous nerves

Outcome measures

Outcome measures
Measure	Ropivacaine and Cholroprocaine Mixture n=30 Participants 20 ml's of 1% ropivacaine + 10 ml's of 3% 2-chloroprocaine + 0.1 ml of 1 mg/ml epinephrine Ropivacine and Chloroprocaine mixture: Chloroprocaine is added to Ropivacaine	Ropivacaine Only n=29 Participants 30 ml syringe with either 20 ml's of 1% ropivacaine + 10 ml's of normal saline + 0.1 ml of 1mg/ml epinephrine Ropivacaine only: Ropivacaine diluted with normal saline instead of chloroprocaine
Onset of Surgical Anesthesia Ulnar-Sensory	16 minutes Interval 10.0 to 28.0	22 minutes Interval 13.0 to 34.0
Onset of Surgical Anesthesia Median-Sensory	9 minutes Interval 4.0 to 16.0	16 minutes Interval 10.0 to 22.0
Onset of Surgical Anesthesia Radial-Sensory	6 minutes Interval 4.0 to 10.0	10 minutes Interval 7.0 to 13.0
Onset of Surgical Anesthesia Musculocutaneous-Sensory	9 minutes Interval 4.0 to 10.0	10 minutes Interval 7.0 to 16.0

SECONDARY outcome

Timeframe: 72 hours

Time interval between the end of local anestehtic injection and the patient's first report of pain in the surgical site after surgery

Outcome measures

Outcome measures
Measure	Ropivacaine and Cholroprocaine Mixture n=30 Participants 20 ml's of 1% ropivacaine + 10 ml's of 3% 2-chloroprocaine + 0.1 ml of 1 mg/ml epinephrine Ropivacine and Chloroprocaine mixture: Chloroprocaine is added to Ropivacaine	Ropivacaine Only n=29 Participants 30 ml syringe with either 20 ml's of 1% ropivacaine + 10 ml's of normal saline + 0.1 ml of 1mg/ml epinephrine Ropivacaine only: Ropivacaine diluted with normal saline instead of chloroprocaine
Duration of Analgesia	566 minutes Interval 428.0 to 670.0	718 minutes Interval 597.0 to 851.0

Adverse Events

Ropivacaine and Cholroprocaine Mixture

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Ropivacaine Only

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ropivacaine and Cholroprocaine Mixture n=30 participants at risk 20 ml's of 1% ropivacaine + 10 ml's of 3% 2-chloroprocaine + 0.1 ml of 1 mg/ml epinephrine Ropivacine and Chloroprocaine mixture: Chloroprocaine is added to Ropivacaine	Ropivacaine Only n=29 participants at risk 30 ml syringe with either 20 ml's of 1% ropivacaine + 10 ml's of normal saline + 0.1 ml of 1mg/ml epinephrine Ropivacaine only: Ropivacaine diluted with normal saline instead of chloroprocaine
Injury, poisoning and procedural complications Block Failure	13.3% 4/30 • Number of events 4	3.4% 1/29 • Number of events 1

Additional Information

Dr. Nicholas Lam

University of New Mexico

Phone: 505-272-2610

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place