Trial Outcomes & Findings for Minimum Effective Concentration of Ropivacaine for Brachial Plexus Block Via the Supraclavicular and Infraclavicular Approach, Femoral Nerve Block, Sciatic Nerve Block Via the Popliteal and Parasacral Approach (NCT NCT01452126)

Results Overview

The concentration of ropivacaine for each patient's nerve-block injection was determined per protocol.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

49 participants

Primary outcome timeframe

1 day

Results posted on

2016-12-19

Participant Flow

Participant milestones

Participant milestones
Measure	Ropivacaine Sequential allocation of ropivacaine concentration depending on the success or failure of surgical anesthesia of the previous patient Ropivacaine concentration: Single shot preoperative perineural injection of ropivacaine to achieve surgical anesthesia. The concentration of ropivacaine is lowered by 0.05% after every successful surgical anesthesia specific to that block and raised by 0.05% after every unsuccessful surgical anesthesia specific to that block
Overall Study STARTED	49
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Minimum Effective Concentration of Ropivacaine for Brachial Plexus Block Via the Supraclavicular and Infraclavicular Approach, Femoral Nerve Block, Sciatic Nerve Block Via the Popliteal and Parasacral Approach

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ropivacaine n=49 Participants Each patient received ropivacaine-based nerve blockade at a fixed volume, with concentration determined per protocol
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Gender Female	19 Participants n=5 Participants
Gender Male	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

The concentration of ropivacaine for each patient's nerve-block injection was determined per protocol.

Outcome measures

Outcome measures
Measure	Femoral Nerve Block n=14 Participants Ropivacaine-based blockade of the femoral nerve, with concentration per protocol.	Supraclavicular Blockade n=13 Participants Ropivacaine-based blockade of the brachial plexus nerves via a supraclavicular approach, with concentration per protocol.	Infraclavicular Blockade n=11 Participants Ropivacaine-based blockade of the brachial plexus nerves via an infraclavicular approach, with concentration per protocol.	Popliteal Nerve Block n=11 Participants Ropivacaine-based blockade of the popliteal nerve, with concentration per protocol.
Effective Concentration of Ropivacaine to Produce Surgical Anesthesia in 50% of Population	0.09 percentage concentration, ropivacaine	0.11 percentage concentration, ropivacaine	0.16 percentage concentration, ropivacaine	0.37 percentage concentration, ropivacaine

SECONDARY outcome

Timeframe: 3 days

All patients were followed up for complications such as bleeding, infection, side effects, nerve damage

Outcome measures

Outcome measures
Measure	Femoral Nerve Block n=49 Participants Ropivacaine-based blockade of the femoral nerve, with concentration per protocol.	Supraclavicular Blockade Ropivacaine-based blockade of the brachial plexus nerves via a supraclavicular approach, with concentration per protocol.	Infraclavicular Blockade Ropivacaine-based blockade of the brachial plexus nerves via an infraclavicular approach, with concentration per protocol.	Popliteal Nerve Block Ropivacaine-based blockade of the popliteal nerve, with concentration per protocol.
Number of Patients With Complications	0 Participants	—	—	—

Adverse Events

Ropivacaine

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ropivacaine n=49 participants at risk Sequential allocation of ropivacaine concentration depending on the success or failure of surgical anesthesia of the previous patient Ropivacaine concentration: Single shot preoperative perineural injection of ropivacaine to achieve surgical anesthesia. The concentration of ropivacaine is lowered by 0.05% after every successful surgical anesthesia specific to that block and raised by 0.05% after every unsuccessful surgical anesthesia specific to that block
Surgical and medical procedures Failure of regional anesthesia	22.4% 11/49 • Number of events 11 • 3 days

Additional Information

Dr Tim Petersen

UNM Department of Anesthesiology

Phone: 5052722610

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place