NCT02557386

Brief Summary

To establish adequate volume of levobupivacaine 0.25% in adductor canal nerve block in unilateral cruciate ligament of the knee reconstruction surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

11 months

First QC Date

September 11, 2015

Last Update Submit

October 10, 2016

Conditions

Anesthesia, Local

Keywords

Cruciate ligament surgeryAdductor canalNerve block

Outcome Measures

Primary Outcomes (1)

  • Change in quadriceps motor force measured in kg*m/sec2

    Using a dynamometer in anterior tibial muscle

    Before nerve block (basal) and 24 hours after surgery

Secondary Outcomes (5)

  • Pain

    Before surgery, 30 minutes after nerve block, one hour after surgery, 48 hours after surgery

  • Rescue analgesia

    24 hours and 48 hours after surgery

  • Patient satisfaction

    48 hours after surgery

  • Change in quadriceps force measured by 30-second chair stand test

    Before nerve block (basal) and 24 hours after surgery

  • Sensitivity block

    30 minutes after adductor canal block

Study Arms (6)

A Levobupivacaine 5 mL

EXPERIMENTAL

Adductor canal nerve block with levobupivacaine 0.25% 5 mL and perineural catheter placement, an elastomeric pump with bupivacaine 0.1% at a rate of 5 ml/hr will be placed after surgery for continuous nerve block.

Drug: Levobupivacaine 5 mL

B Levobupivacaine 10 mL

EXPERIMENTAL

Adductor canal nerve block with levobupivacaine 0.25% 10 mL and perineural catheter placement, an elastomeric pump with bupivacaine 0.1% at a rate of 5 ml/hr will be placed after surgery for continuous nerve block.

Drug: Levobupivacaine 10 mL

C Levobupivacaine 15 mL

EXPERIMENTAL

Adductor canal nerve block with levobupivacaine 0.25% 15 mL and perineural catheter placement, an elastomeric pump with bupivacaine 0.1% at a rate of 5 ml/hr will be placed after surgery for continuous nerve block.

Drug: Levobupivacaine 15 mL

D Levobupivacaine 20 mL

EXPERIMENTAL

Adductor canal nerve block with levobupivacaine 0.25% 20 mL and perineural catheter placement, an elastomeric pump with bupivacaine 0.1% at a rate of 5 ml/hr will be placed after surgery for continuous nerve block.

Drug: Levobupivacaine 20 mL

E Levobupivacaine 25 mL

EXPERIMENTAL

Adductor canal nerve block with levobupivacaine 0.25% 25 mL and perineural catheter placement, an elastomeric pump with bupivacaine 0.1% at a rate of 5 ml/hr will be placed after surgery for continuous nerve block.

Drug: Levobupivacaine 25 mL

F Levobupivacaine 30 mL

EXPERIMENTAL

Adductor canal nerve block with levobupivacaine 0.25% 30 mL and perineural catheter placement, an elastomeric pump with bupivacaine 0.1% at a rate of 5 ml/hr will be placed after surgery for continuous nerve block.

Drug: Levobupivacaine 30 mL

Interventions

Levobupivacaine 5 mLDRUG

Levobupivacaine 0.25% 5 mL in adductor canal nerve block

Also known as: Chirocaine
A Levobupivacaine 5 mL
Levobupivacaine 10 mLDRUG

Levobupivacaine 0.25% 10 mL in adductor canal nerve block

Also known as: Chirocaine
B Levobupivacaine 10 mL
Levobupivacaine 15 mLDRUG

Levobupivacaine 0.25% 15 mL in adductor canal nerve block

Also known as: Chirocaine
C Levobupivacaine 15 mL
Levobupivacaine 20 mLDRUG

Levobupivacaine 0.25% 20 mL in adductor canal nerve block

Also known as: Chirocaine
D Levobupivacaine 20 mL
Levobupivacaine 25 mLDRUG

Levobupivacaine 0.25% 25 mL in adductor canal nerve block

Also known as: Chirocaine
E Levobupivacaine 25 mL
Levobupivacaine 30 mLDRUG

Levobupivacaine 0.25% 30 mL in adductor canal nerve block

Also known as: Chirocaine
F Levobupivacaine 30 mL

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male sex
  • ASA status I or II
  • BMI between 20 and 34 kg/m2
  • Cruciate ligament of the knee reconstructive surgery
  • No contraindications to general and regional anesthesia

You may not qualify if:

  • Chronic pain more than 3 months
  • Drug abuse
  • Chronic use of analgesic drugs (more than 3 months)
  • Psychiatric illness
  • Peripheral neuropathy
  • Drug allergy
  • Severe gastroesophageal reflux disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division de Anestesia - Pontificia Universidad Catolica de Chile

Santiago, Santiago Metropolitan, 8330024, Chile

RECRUITING

Related Publications (25)

  • Williams BA, Kentor ML, Vogt MT, Williams JP, Chelly JE, Valalik S, Harner CD, Fu FH. Femoral-sciatic nerve blocks for complex outpatient knee surgery are associated with less postoperative pain before same-day discharge: a review of 1,200 consecutive cases from the period 1996-1999. Anesthesiology. 2003 May;98(5):1206-13. doi: 10.1097/00000542-200305000-00024.

    PMID: 12717143BACKGROUND

  • Grevstad U, Mathiesen O, Lind T, Dahl JB. Effect of adductor canal block on pain in patients with severe pain after total knee arthroplasty: a randomized study with individual patient analysis. Br J Anaesth. 2014 May;112(5):912-9. doi: 10.1093/bja/aet441. Epub 2014 Jan 8.

    PMID: 24401802BACKGROUND

  • Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.

    PMID: 10422923BACKGROUND

  • Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.

    PMID: 24401769BACKGROUND

  • Allen HW, Liu SS, Ware PD, Nairn CS, Owens BD. Peripheral nerve blocks improve analgesia after total knee replacement surgery. Anesth Analg. 1998 Jul;87(1):93-7. doi: 10.1097/00000539-199807000-00020.

    PMID: 9661553BACKGROUND

  • Hadzic A, Houle TT, Capdevila X, Ilfeld BM. Femoral nerve block for analgesia in patients having knee arthroplasty. Anesthesiology. 2010 Nov;113(5):1014-5. doi: 10.1097/ALN.0b013e3181f4b43d. No abstract available.

    PMID: 20881593BACKGROUND

  • Charous MT, Madison SJ, Suresh PJ, Sandhu NS, Loland VJ, Mariano ER, Donohue MC, Dutton PH, Ferguson EJ, Ilfeld BM. Continuous femoral nerve blocks: varying local anesthetic delivery method (bolus versus basal) to minimize quadriceps motor block while maintaining sensory block. Anesthesiology. 2011 Oct;115(4):774-81. doi: 10.1097/ALN.0b013e3182124dc6.

    PMID: 21394001BACKGROUND

  • Kandasami M, Kinninmonth AW, Sarungi M, Baines J, Scott NB. Femoral nerve block for total knee replacement - a word of caution. Knee. 2009 Mar;16(2):98-100. doi: 10.1016/j.knee.2008.10.007. Epub 2008 Nov 28.

    PMID: 19046884BACKGROUND

  • Ilfeld BM, Duke KB, Donohue MC. The association between lower extremity continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty. Anesth Analg. 2010 Dec;111(6):1552-4. doi: 10.1213/ANE.0b013e3181fb9507. Epub 2010 Oct 1.

    PMID: 20889937BACKGROUND

  • Muraskin SI, Conrad B, Zheng N, Morey TE, Enneking FK. Falls associated with lower-extremity-nerve blocks: a pilot investigation of mechanisms. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):67-72. doi: 10.1016/j.rapm.2006.08.013.

    PMID: 17196495BACKGROUND

  • Jaeger P, Grevstad U, Henningsen MH, Gottschau B, Mathiesen O, Dahl JB. Effect of adductor-canal-blockade on established, severe post-operative pain after total knee arthroplasty: a randomised study. Acta Anaesthesiol Scand. 2012 Sep;56(8):1013-9. doi: 10.1111/j.1399-6576.2012.02737.x. Epub 2012 Jul 26.

    PMID: 22834681BACKGROUND

  • Krombach J, Gray AT. Sonography for saphenous nerve block near the adductor canal. Reg Anesth Pain Med. 2007 Jul-Aug;32(4):369-70. doi: 10.1016/j.rapm.2007.04.006. No abstract available.

    PMID: 17720129BACKGROUND

  • Horn JL, Pitsch T, Salinas F, Benninger B. Anatomic basis to the ultrasound-guided approach for saphenous nerve blockade. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):486-9. doi: 10.1097/AAP.0b013e3181ae11af.

    PMID: 19920424BACKGROUND

  • Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.

    PMID: 22221014BACKGROUND

  • Lund J, Jenstrup MT, Jaeger P, Sorensen AM, Dahl JB. Continuous adductor-canal-blockade for adjuvant post-operative analgesia after major knee surgery: preliminary results. Acta Anaesthesiol Scand. 2011 Jan;55(1):14-9. doi: 10.1111/j.1399-6576.2010.02333.x. Epub 2010 Oct 29.

    PMID: 21039357BACKGROUND

  • Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. Adductor canal block versus femoral nerve block and quadriceps strength: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 10.1097/ALN.0b013e318279fa0b.

    PMID: 23241723BACKGROUND

  • Kwofie MK, Shastri UD, Gadsden JC, Sinha SK, Abrams JH, Xu D, Salviz EA. The effects of ultrasound-guided adductor canal block versus femoral nerve block on quadriceps strength and fall risk: a blinded, randomized trial of volunteers. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):321-5. doi: 10.1097/AAP.0b013e318295df80.

    PMID: 23788068BACKGROUND

  • Saranteas T, Anagnostis G, Paraskeuopoulos T, Koulalis D, Kokkalis Z, Nakou M, Anagnostopoulou S, Kostopanagiotou G. Anatomy and clinical implications of the ultrasound-guided subsartorial saphenous nerve block. Reg Anesth Pain Med. 2011 Jul-Aug;36(4):399-402. doi: 10.1097/AAP.0b013e318220f172.

    PMID: 21697687BACKGROUND

  • Chen J, Lesser JB, Hadzic A, Reiss W, Resta-Flarer F. Adductor canal block can result in motor block of the quadriceps muscle. Reg Anesth Pain Med. 2014 Mar-Apr;39(2):170-1. doi: 10.1097/AAP.0000000000000053.

    PMID: 24553306BACKGROUND

  • Davis JJ, Bond TS, Swenson JD. Adductor canal block: more than just the saphenous nerve? Reg Anesth Pain Med. 2009 Nov-Dec;34(6):618-9. doi: 10.1097/AAP.0b013e3181bfbf00. No abstract available.

    PMID: 19901788BACKGROUND

  • Choi S, Trang A, McCartney CJ. Reporting functional outcome after knee arthroplasty and regional anesthesia: a methodological primer. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):340-9. doi: 10.1097/AAP.0b013e318295d973.

    PMID: 23788070BACKGROUND

  • Bohannon RW. Measuring knee extensor muscle strength. Am J Phys Med Rehabil. 2001 Jan;80(1):13-8. doi: 10.1097/00002060-200101000-00004.

    PMID: 11138949BACKGROUND

  • Jaeger P, Koscielniak-Nielsen ZJ, Schroder HM, Mathiesen O, Henningsen MH, Lund J, Jenstrup MT, Dahl JB. Adductor canal block for postoperative pain treatment after revision knee arthroplasty: a blinded, randomized, placebo-controlled study. PLoS One. 2014 Nov 11;9(11):e111951. doi: 10.1371/journal.pone.0111951. eCollection 2014.

    PMID: 25386752BACKGROUND

  • Munoz HR, Cortinez LI, Altermatt FR, Dagnino JA. Remifentanil requirements during sevoflurane administration to block somatic and cardiovascular responses to skin incision in children and adults. Anesthesiology. 2002 Nov;97(5):1142-5. doi: 10.1097/00000542-200211000-00018.

    PMID: 12411799BACKGROUND

  • Bouvet L, Da-Col X, Chassard D, Dalery F, Ruynat L, Allaouchiche B, Dantony E, Boselli E. ED(5)(0) and ED(9)(5) of intrathecal levobupivacaine with opioids for Caesarean delivery. Br J Anaesth. 2011 Feb;106(2):215-20. doi: 10.1093/bja/aeq296. Epub 2010 Oct 30.

    PMID: 21037268BACKGROUND

MeSH Terms

Interventions

Levobupivacaine

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Fernando R Altermatt, MD

    Associate Professor Ordinary Category

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando R Altermatt, MD

CONTACT

56-2-23543270falterma@med.puc.cl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2015

First Posted

September 23, 2015

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

October 12, 2016

Record last verified: 2016-10

Locations

CL(1)