Adductor Canal Block and Effect of 10 Versus 30 ml Ropivacaine on Muscle Strength: a Randomized Study in Healthy Volunteers

NCT01981746 | Completed Phase 4 DMC

• 1 other identifier: SM2-PJ-13
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate whether reducing the volume (30 versus 10 ml) ropivacaine injected can reduce the number of subjects with impaired muscle strength following adductor canal block. We hypothesized that adductor canal block with 10 ml 0.1% ropivacaine preserves quadriceps strength compared with an adductor canal block with 30 ml.

Conditions

Muscle Strength; Healthy Volunteers

Keywords

adductor canal block; healthy volunteers; US-guided peripheral nerve block; lower limb

Outcome Measures

Primary Outcomes (1)

• Number of subjects with reduced quadriceps strength

  The difference between the two volumes in number of subjects experiencing a reduction in quadriceps muscle strength by more than 25% from baseline in two consecutive assessments.

  0.5 to 6 hours post block

Secondary Outcomes (4)

• Quadriceps strength in percentage of baseline

  2, 3 and 4 hours post block

• Quadriceps strength calculated as AUC

  30 minutes to 6 hours post block

• Modified 30-second Chair Stand test

  2 and 4 hours post block

• VAS pain scores during warmth stimulation

  Mean value for the periode 30 minutes - 6 hours post block

Study Arms (2)

30 ml

EXPERIMENTAL

30 ml ropivacaine 0.1%, single bolus

Procedure: Adductor canal block with ropivacaine 0.1%

10 ml

EXPERIMENTAL

10 ml 0.1% ropivacaine, single bolus

Procedure: Adductor canal block with ropivacaine 0.1%

Interventions

Adductor canal block with ropivacaine 0.1% PROCEDURE

US-guided adductor canal block

10 ml; 30 ml

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years
• Men
• ASA 1
• Body Mass Index 18-25

You may not qualify if:

• Allergy to study medication
• Earlier trauma or surgery to the lower limb
• Diabetes Mellitus

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (2)

• Jaeger P, Grevstad U, Koscielniak-Nielsen ZJ, Sauter AR, Sorensen JK, Dahl JB. Does dexamethasone have a perineural mechanism of action? A paired, blinded, randomized, controlled study in healthy volunteers. Br J Anaesth. 2016 Nov;117(5):635-641. doi: 10.1093/bja/aew318.

  PMID: 27799178 DERIVED

• Jaeger P, Koscielniak-Nielsen ZJ, Hilsted KL, Fabritius ML, Dahl JB. Adductor Canal Block With 10 mL Versus 30 mL Local Anesthetics and Quadriceps Strength: A Paired, Blinded, Randomized Study in Healthy Volunteers. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):553-8. doi: 10.1097/AAP.0000000000000298.

  PMID: 26237001 DERIVED

Study Officials

• Pia Jaeger, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 11, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 10, 2014

Record last verified: 2014-01

Locations

DK (1)