Clinical trial NCT02557386: Optimal Volume of Bupivacaine in Adductor Canal Nerve Block
Official title: Optimal Volume of Bupivacaine in Adductor Canal Nerve Block in Patients Undergoing Unilateral Cruciate Ligament Reconstruction Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia, Local
Keywords: Cruciate ligament surgery
Adductor canal
Nerve block
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2015-09-23
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in quadriceps motor force measured in kg*m/sec2
timeFrame: Before nerve block (basal) and 24 hours after surgery
Secondary outcomes:
measure: Pain
timeFrame: Before surgery, 30 minutes after nerve block, one hour after surgery, 48 hours after surgery
measure: Rescue analgesia
timeFrame: 24 hours and 48 hours after surgery
measure: Patient satisfaction
timeFrame: 48 hours after surgery
measure: Change in quadriceps force measured by 30-second chair stand test
timeFrame: Before nerve block (basal) and 24 hours after surgery
measure: Sensitivity block
timeFrame: 30 minutes after adductor canal block
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Division de Anestesia - Pontificia Universidad Catolica de Chile
state: Region Metropolitana
Study officials:
affiliation: Associate Professor Ordinary Category
name: Fernando R Altermatt, MD
role: PRINCIPAL_INVESTIGATOR
References:
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