Optimal Volume of Bupivacaine in Adductor Canal Nerve Block

October 10, 2016 updated by: Pontificia Universidad Catolica de Chile

Optimal Volume of Bupivacaine in Adductor Canal Nerve Block in Patients Undergoing Unilateral Cruciate Ligament Reconstruction Surgery

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Chile
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile, 8330024
        • Recruiting
        • Division de Anestesia - Pontificia Universidad Catolica de Chile
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Andrea Araneda, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Chirocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Before nerve block (basal) and 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Before surgery, 30 minutes after nerve block, one hour after surgery, 48 hours after surgery
Rescue analgesia
Time Frame: 24 hours and 48 hours after surgery
Lidocaine 1% bolus through nerve block catheter and opioid use, measured in mg
24 hours and 48 hours after surgery
Patient satisfaction
Time Frame: 48 hours after surgery
Using a 5 point scale from 1 (very unsatisfied) to 5 (very satisfied)
48 hours after surgery
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
Before nerve block (basal) and 24 hours after surgery
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.
30 minutes after adductor canal block

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Investigators

  • Principal Investigator: Fernando R Altermatt, MD, Associate Professor Ordinary Category

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

September 11, 2015

First Submitted That Met QC Criteria

September 21, 2015

First Posted (Estimate)

September 23, 2015

Study Record Updates

Last Update Posted (Estimate)

October 12, 2016

Last Update Submitted That Met QC Criteria

October 10, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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