The Effect of Different Doses (Mass) of Local Anesthetic on Duration of Adductor Canal Block in Healthy Volunteers - Part 2
Overview
- Phase
- Phase 4
- Intervention
- Adductor canal block with 20 ml lidocaine, single bolus
- Conditions
- Healthy
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Duration of sensory block assessed with pinprick.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
To investigate whether increased dose of local anesthetic (lidocaine) increases duration of peripheral nerve block (adductor canal block) and to develop a model for assessing duration of peripheral nerve blockades. The investigators hypothesize that increasing the dose of lidocaine (by increased concentration) will increase the duration of an adductor canal block.
The study is a follow up on an identical study (SM1-PJ-13, EudraCT number: 2013-001822-24 ) made earlier with different concentrations of lidocaine and a placebo group. For further information see trial registration at European Union Drug Regulatory Authorities Clinical Trial System.
Investigators
Pia Jaeger
Principal investigator
Rigshospitalet, Denmark
Eligibility Criteria
Inclusion Criteria
- •Body mass index 18-25
Exclusion Criteria
- •Allergy to study medication
- •Earlier trauma or surgery to lower limb
- •Diabetes Mellitus
Arms & Interventions
ACB with lidocaine 5 mg/ml
Adductor canal block (ACB) with 20 ml lidocaine 5 mg/ml, single bolus
Intervention: Adductor canal block with 20 ml lidocaine, single bolus
ACB with lidocaine 15 mg/ml
Adductor canal block with 20 ml lidocaine 15 mg/ml, single bolus
Intervention: Adductor canal block with 20 ml lidocaine, single bolus
Outcomes
Primary Outcomes
Duration of sensory block assessed with pinprick.
Time Frame: 0-10 hours
Duration is defined as the time from block performance until recovery of sensation to pin-prick stimulus, assessed at 30 and 60 minutes post block, and thereafter every hour.
Secondary Outcomes
- Duration of sensory block assessed by heat pain detection threshold(0-10 hours)
- Duration of sensory block assessed by warmth detection threshold(0-10 hours)
- Duration of sensory block assessed by pain during 1 minute of warmth stimulation(0-10 hours)
- Duration of sensory block assessed by tolerance to transcutaneal electrical stimulation(0-10 hours)
- Duration of sensory block assessed by cold sensation with an alcohol swab(0-10 hours)
- Duration of motor block assessed as maximum voluntary isometric contraction.(0-10 hours)
- Time to onset of sensory block assessed by pinprick.(0-2 hours)