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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

Tracking Information
First Submitted Date  ICMJE September 11, 2015
First Posted Date  ICMJE September 23, 2015
Last Update Posted Date October 12, 2016
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02557386 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2015)
  • 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)
  • Rescue analgesia [ Time Frame: 24 hours and 48 hours after surgery ]
    Lidocaine 1% bolus through nerve block catheter and opioid use, measured in mg
  • Patient satisfaction [ Time Frame: 48 hours after surgery ]
    Using a 5 point scale from 1 (very unsatisfied) to 5 (very satisfied)
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimal Volume of Bupivacaine in Adductor Canal Nerve Block
Official Title  ICMJE Optimal Volume of Bupivacaine in Adductor Canal Nerve Block in Patients Undergoing Unilateral Cruciate Ligament Reconstruction Surgery
Brief Summary To establish adequate volume of levobupivacaine 0.25% in adductor canal nerve block in unilateral cruciate ligament of the knee reconstruction surgery.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Anesthesia, Local
Intervention  ICMJE
  • Drug: Levobupivacaine 5 mL
    Levobupivacaine 0.25% 5 mL in adductor canal nerve block
    Other Name: Chirocaine
  • Drug: Levobupivacaine 10 mL
    Levobupivacaine 0.25% 10 mL in adductor canal nerve block
    Other Name: Chirocaine
  • Drug: Levobupivacaine 15 mL
    Levobupivacaine 0.25% 15 mL in adductor canal nerve block
    Other Name: Chirocaine
  • Drug: Levobupivacaine 20 mL
    Levobupivacaine 0.25% 20 mL in adductor canal nerve block
    Other Name: Chirocaine
  • Drug: Levobupivacaine 25 mL
    Levobupivacaine 0.25% 25 mL in adductor canal nerve block
    Other Name: Chirocaine
  • Drug: Levobupivacaine 30 mL
    Levobupivacaine 0.25% 30 mL in adductor canal nerve block
    Other Name: Chirocaine
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Levobupivacaine 5 mL
  • 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.
    Intervention: Drug: Levobupivacaine 10 mL
  • 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.
    Intervention: Drug: Levobupivacaine 15 mL
  • 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.
    Intervention: Drug: Levobupivacaine 20 mL
  • 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.
    Intervention: Drug: Levobupivacaine 25 mL
  • 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.
    Intervention: Drug: Levobupivacaine 30 mL
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 21, 2015)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2017
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02557386
Other Study ID Numbers  ICMJE 15-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Pontificia Universidad Catolica de Chile
Study Sponsor  ICMJE Pontificia Universidad Catolica de Chile
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fernando R Altermatt, MD Associate Professor Ordinary Category
PRS Account Pontificia Universidad Catolica de Chile
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP