Optimal Volume of Bupivacaine in Adductor Canal Nerve Block

NCT ID: NCT02557386

Last Updated: 2016-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-03-31

Brief Summary

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

Detailed Description

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The complex knee surgery has been associated with severe postoperative pain. Different analgesic techniques for postoperative management of this increasingly common surgery, with main purpose of adequately control pain, minimizing adverse effects and seeking early rehabilitation.

Currently, the most used technique is the continuous femoral nerve block, which is able to control postoperative pain well, but has the limitation that also produces motor blockade, decreasing quadriceps strength up to 80%, increasing the number of falls and delaying early mobilization after surgery. On the other hand, the adductor canal nerve block is an alternative as it is considered a purely sensitive block. The nerves that are in this channel are the saphenous adductor nerve, posterior branches of the obturator nerve, medial vast nerve, sometimes the medial cutaneous nerve and anterior branches of the obturator nerve and the vast medial nerve.

With regard to the adductor canal block, current literature supports analgesic effect comparable to femoral nerve block with less motor block than femoral nerve block. However, there is no clarity regarding the ideal concentration and volume of local anesthetics to use. Volumes ranging from 5 to 30 ml have been used in different studies. For example, using 20 mL of local anesthetic in femoral nerve block has produced scattering of anesthetic that has blocked motor branches.

The investigators objective is to determine which volume of levobupivacaine 0.25% is necessary to produce analgesia and sensitive blockade while minimizing motor blockade in adductor canal nerve block in patients undergoing cruciate ligament reconstruction surgery.

Conditions

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Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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A Levobupivacaine 5 mL

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.

Group Type EXPERIMENTAL

Levobupivacaine 5 mL

Intervention Type DRUG

Levobupivacaine 0.25% 5 mL in adductor canal nerve block

B Levobupivacaine 10 mL

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.

Group Type EXPERIMENTAL

Levobupivacaine 10 mL

Intervention Type DRUG

Levobupivacaine 0.25% 10 mL in adductor canal nerve block

C Levobupivacaine 15 mL

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.

Group Type EXPERIMENTAL

Levobupivacaine 15 mL

Intervention Type DRUG

Levobupivacaine 0.25% 15 mL in adductor canal nerve block

D Levobupivacaine 20 mL

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.

Group Type EXPERIMENTAL

Levobupivacaine 20 mL

Intervention Type DRUG

Levobupivacaine 0.25% 20 mL in adductor canal nerve block

E Levobupivacaine 25 mL

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.

Group Type EXPERIMENTAL

Levobupivacaine 25 mL

Intervention Type DRUG

Levobupivacaine 0.25% 25 mL in adductor canal nerve block

F Levobupivacaine 30 mL

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.

Group Type EXPERIMENTAL

Levobupivacaine 30 mL

Intervention Type DRUG

Levobupivacaine 0.25% 30 mL in adductor canal nerve block

Interventions

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Levobupivacaine 5 mL

Levobupivacaine 0.25% 5 mL in adductor canal nerve block

Intervention Type DRUG

Levobupivacaine 10 mL

Levobupivacaine 0.25% 10 mL in adductor canal nerve block

Intervention Type DRUG

Levobupivacaine 15 mL

Levobupivacaine 0.25% 15 mL in adductor canal nerve block

Intervention Type DRUG

Levobupivacaine 20 mL

Levobupivacaine 0.25% 20 mL in adductor canal nerve block

Intervention Type DRUG

Levobupivacaine 25 mL

Levobupivacaine 0.25% 25 mL in adductor canal nerve block

Intervention Type DRUG

Levobupivacaine 30 mL

Levobupivacaine 0.25% 30 mL in adductor canal nerve block

Intervention Type DRUG

Other Intervention Names

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Chirocaine Chirocaine Chirocaine Chirocaine Chirocaine Chirocaine

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fernando R Altermatt, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor Ordinary Category

Locations

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Division de Anestesia - Pontificia Universidad Catolica de Chile

Santiago, Santiago Metropolitan, Chile

Site Status RECRUITING

Countries

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Chile

Central Contacts

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Fernando R Altermatt, MD

Role: CONTACT

56-2-23543270

Facility Contacts

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Fernando R Altermatt, MSc

Role: primary

56-2-23543270

Sebastian Paredes, MD

Role: backup

56-2-23543270

References

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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.

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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.

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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.

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PMID: 21394001 (View on PubMed)

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Reference Type BACKGROUND
PMID: 20889937 (View on PubMed)

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.

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PMID: 17196495 (View on PubMed)

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Reference Type BACKGROUND
PMID: 22834681 (View on PubMed)

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Reference Type BACKGROUND
PMID: 17720129 (View on PubMed)

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.

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Reference Type BACKGROUND
PMID: 22221014 (View on PubMed)

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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.

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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.

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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.

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Other Identifiers

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15-001

Identifier Type: -

Identifier Source: org_study_id

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