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Optimal Volume of Bupivacaine in Adductor Canal Nerve Block

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ClinicalTrials.gov Identifier: NCT02557386
Recruitment Status : Unknown
Verified October 2016 by Pontificia Universidad Catolica de Chile.
Recruitment status was:  Recruiting
First Posted : September 23, 2015
Last Update Posted : October 12, 2016
Sponsor:
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

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

Condition or disease Intervention/treatment Phase
Anesthesia, Local Drug: Levobupivacaine 5 mL Drug: Levobupivacaine 10 mL Drug: Levobupivacaine 15 mL Drug: Levobupivacaine 20 mL Drug: Levobupivacaine 25 mL Drug: Levobupivacaine 30 mL Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimal Volume of Bupivacaine in Adductor Canal Nerve Block in Patients Undergoing Unilateral Cruciate Ligament Reconstruction Surgery
Study Start Date : January 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine

Arm Intervention/treatment
Experimental: 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.
Drug: Levobupivacaine 5 mL
Levobupivacaine 0.25% 5 mL in adductor canal nerve block
Other Name: Chirocaine

Experimental: 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.
Drug: Levobupivacaine 10 mL
Levobupivacaine 0.25% 10 mL in adductor canal nerve block
Other Name: Chirocaine

Experimental: 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.
Drug: Levobupivacaine 15 mL
Levobupivacaine 0.25% 15 mL in adductor canal nerve block
Other Name: Chirocaine

Experimental: 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.
Drug: Levobupivacaine 20 mL
Levobupivacaine 0.25% 20 mL in adductor canal nerve block
Other Name: Chirocaine

Experimental: 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.
Drug: Levobupivacaine 25 mL
Levobupivacaine 0.25% 25 mL in adductor canal nerve block
Other Name: Chirocaine

Experimental: 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.
Drug: Levobupivacaine 30 mL
Levobupivacaine 0.25% 30 mL in adductor canal nerve block
Other Name: Chirocaine




Primary Outcome Measures :
  1. Change in quadriceps motor force measured in kg*m/sec2 [ Time Frame: Before nerve block (basal) and 24 hours after surgery ]
    Using a dynamometer in anterior tibial muscle


Secondary Outcome Measures :
  1. Pain [ Time Frame: Before surgery, 30 minutes after nerve block, one hour after surgery, 48 hours after surgery ]
    Using visual analogue scale, static and dynamic evaluation, scale from 0 (no pain) to 10 (worst pain imaginable)

  2. Rescue analgesia [ Time Frame: 24 hours and 48 hours after surgery ]
    Lidocaine 1% bolus through nerve block catheter and opioid use, measured in mg

  3. Patient satisfaction [ Time Frame: 48 hours after surgery ]
    Using a 5 point scale from 1 (very unsatisfied) to 5 (very satisfied)

  4. Change in quadriceps force measured by 30-second chair stand test [ Time Frame: Before nerve block (basal) and 24 hours after surgery ]
    Using 30-second chair stand test, how many times patient can stand up in 30 seconds, number of times is recorded

  5. Sensitivity block [ Time Frame: 30 minutes after adductor canal block ]
    Using a sensitivity scale ranging from 0 (no sensitivity), 1 (paresthesias) and 2 (normal sensitivity. Measured with needle prick and cold sensitivity.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557386


Contacts
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Contact: Fernando R Altermatt, MD 56-2-23543270 falterma@med.puc.cl

Locations
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Chile
Division de Anestesia - Pontificia Universidad Catolica de Chile Recruiting
Santiago, Region Metropolitana, Chile, 8330024
Contact: Fernando R Altermatt, MSc    56-2-23543270    fernando.altermatt@gmail.com   
Contact: Sebastian Paredes, MD    56-2-23543270    sparedese@gmail.com   
Sub-Investigator: Andrea Araneda, MD         
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
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Principal Investigator: Fernando R Altermatt, MD Associate Professor Ordinary Category

Publications:

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Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT02557386     History of Changes
Other Study ID Numbers: 15-001
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Pontificia Universidad Catolica de Chile:
Cruciate ligament surgery
Adductor canal
Nerve block
Additional relevant MeSH terms:
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Bupivacaine
Levobupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents