Trial Outcomes & Findings for Ultrasound Guided Distal Sciatic Nerve Block - a Comparison With Nerve Stimulator Technique (NCT NCT01643616)

Results Overview

After injection of local anesthetic a waiting period of 30-60 minutes was defined before completing a failed block. 1. success without supplementation = no additional analgetics or rescue blocks required (success rate without supplementation, outcome measure 1) 2. success with supplementation = analgetics or selective rescue blocks distal of the sciatic division required (success rate without supplementation and additionally all supplemented blocks, outcome measure 3) 3. failed block = change of anesthetic procedure (general, spinal) or rescue blocks proximal of the sciatic division

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

250 participants

Primary outcome timeframe

within 30-60 minutes after injection of the local anesthetic

Results posted on

2013-11-01

Participant Flow

Adult patients were informed and included in the study in the anesthesiology outpatient clinic as part of normal pre-operative preparation. Using a computer-generated list of random numbers, patients were randomly allocated to either the nerve stimulation group (NS group, n=125) or the ultrasound group (US group, n=125).

Participant milestones

Participant milestones
Measure	Group US Ultrasound guided block : 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)	Group NS Nerve stimulation technique: 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)
Overall Study STARTED	125	125
Overall Study COMPLETED	125	125
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ultrasound Guided Distal Sciatic Nerve Block - a Comparison With Nerve Stimulator Technique

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group US n=125 Participants Ultrasound guided block : 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)	Group NS n=125 Participants Nerve stimulation technique: 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)	Total n=250 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	99 Participants n=5 Participants	95 Participants n=7 Participants	194 Participants n=5 Participants
Age, Categorical >=65 years	26 Participants n=5 Participants	30 Participants n=7 Participants	56 Participants n=5 Participants
Age Continuous	53.4 years STANDARD_DEVIATION 14.3 • n=5 Participants	56.4 years STANDARD_DEVIATION 11.8 • n=7 Participants	54.9 years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male Female	107 Participants n=5 Participants	91 Participants n=7 Participants	198 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	34 Participants n=7 Participants	52 Participants n=5 Participants
Region of Enrollment Germany	125 participants n=5 Participants	125 participants n=7 Participants	250 participants n=5 Participants

PRIMARY outcome

Timeframe: within 30-60 minutes after injection of the local anesthetic

Population: In the NS group two investigators were necessary in order to realize the blinded study protocol. For personnel reasons this was not possible in every case and led to deviations from the randomization protocol for seven patients in each group. These patients were excluded from the analysis.

After injection of local anesthetic a waiting period of 30-60 minutes was defined before completing a failed block. 1. success without supplementation = no additional analgetics or rescue blocks required (success rate without supplementation, outcome measure 1) 2. success with supplementation = analgetics or selective rescue blocks distal of the sciatic division required (success rate without supplementation and additionally all supplemented blocks, outcome measure 3) 3. failed block = change of anesthetic procedure (general, spinal) or rescue blocks proximal of the sciatic division

Outcome measures

Outcome measures
Measure	Group US n=118 Participants Ultrasound guided block : 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)	Group NS n=118 Participants Nerve stimulation technique: 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)
Success Rate Without Supplementation	112 participants	73 participants

PRIMARY outcome

Timeframe: within 60 minutes after injection of the local anesthetic

Outcome measures

Outcome measures
Measure	Group US n=118 Participants Ultrasound guided block : 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)	Group NS n=118 Participants Nerve stimulation technique: 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)
Time Until Readiness for Surgery (Minutes)	15.1 minutes Interval 13.6 to 16.5	28 minutes Interval 24.9 to 31.1

PRIMARY outcome

Timeframe: later than 30-60 minutes after injection of the local anesthetic

After injection of local anesthetic a waiting period of 30-60 minutes was defined before completing a failed block. 1. success without supplementation = no additional analgetics or rescue blocks required (success rate without supplementation, outcome measure 1) 2. success with supplementation = analgetics or selective rescue blocks distal of the sciatic division required (success rate without supplementation and additionally all supplemented blocks, outcome measure 3) 3. failed block = change of anesthetic procedure (general, spinal) or rescue blocks proximal of the sciatic divisionSucces rate with supplementation

Outcome measures

Outcome measures
Measure	Group US n=118 Participants Ultrasound guided block : 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)	Group NS n=118 Participants Nerve stimulation technique: 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)
Success Rate With Supplementation	116 participants	85 participants

Adverse Events

Group US

Serious events: 0 serious events

Other events: 66 other events

Deaths: 0 deaths

Group NS

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group US n=125 participants at risk Ultrasound guided block : 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)	Group NS n=125 participants at risk Nerve stimulation technique: 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)
Nervous system disorders polyradicular sensomotor impairment	0.00% 0/125	0.80% 1/125 • Number of events 1

Other adverse events

Other adverse events
Measure	Group US n=125 participants at risk Ultrasound guided block : 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)	Group NS n=125 participants at risk Nerve stimulation technique: 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)
Nervous system disorders Paresthesia	52.8% 66/125 • Number of events 66	19.2% 24/125 • Number of events 24

Additional Information

Dr. Ronald Seidel

HELIOS-Kliniken Schwerin, Germany

Phone: 0049 385 5204251

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place