Optimal Volume of Bupivacaine in Adductor Canal Nerve Block

Study Overview
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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.

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

Conditions
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Anesthesia, Local

Intervention / Treatment
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* Drug: Levobupivacaine 5 mL
* Drug: Levobupivacaine 10 mL
* Drug: Levobupivacaine 15 mL
* Drug: Levobupivacaine 20 mL
* Drug: Levobupivacaine 25 mL
* Drug: Levobupivacaine 30 mL


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A Levobupivacaine 5 mL<br>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<br>* Levobupivacaine 0.25% 5 mL in adductor canal nerve block<br>* Other names: Chirocaine;|
| Experimental: B Levobupivacaine 10 mL<br>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<br>* Levobupivacaine 0.25% 10 mL in adductor canal nerve block<br>* Other names: Chirocaine;|
| Experimental: C Levobupivacaine 15 mL<br>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<br>* Levobupivacaine 0.25% 15 mL in adductor canal nerve block<br>* Other names: Chirocaine;|
| Experimental: D Levobupivacaine 20 mL<br>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<br>* Levobupivacaine 0.25% 20 mL in adductor canal nerve block<br>* Other names: Chirocaine;|
| Experimental: E Levobupivacaine 25 mL<br>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<br>* Levobupivacaine 0.25% 25 mL in adductor canal nerve block<br>* Other names: Chirocaine;|
| Experimental: F Levobupivacaine 30 mL<br>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<br>* Levobupivacaine 0.25% 30 mL in adductor canal nerve block<br>* Other names: Chirocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | 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 | Lidocaine 1% bolus through nerve block catheter and opioid use, measured in mg | 24 hours and 48 hours after surgery | 
| Patient satisfaction | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cruciate ligament surgery, Adductor canal, Nerve block