Optimal Volume of Bupivacaine in Adductor Canal Nerve Block

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02557386
• Other study ID #: 15-001
• Status: Recruiting
• Phase: Phase 4
• First received: September 11, 2015
• Last updated: October 10, 2016
• Start date: January 2016
• Est. completion date: March 2017

Study information

• Verified date: October 2016
• Source: Pontificia Universidad Catolica de Chile
• Contact: Fernando R Altermatt, MD
• Phone: 56-2-23543270
• Email: falterma[@]med.puc.cl
• Is FDA regulated: No
• Health authority: Chile: Comité de Ética Científico
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

Drug:
• Levobupivacaine 5 mL
Levobupivacaine 0.25% 5 mL in adductor canal nerve block
• Levobupivacaine 10 mL
Levobupivacaine 0.25% 10 mL in adductor canal nerve block
• Levobupivacaine 15 mL
Levobupivacaine 0.25% 15 mL in adductor canal nerve block
• Levobupivacaine 20 mL
Levobupivacaine 0.25% 20 mL in adductor canal nerve block
• Levobupivacaine 25 mL
Levobupivacaine 0.25% 25 mL in adductor canal nerve block
• Levobupivacaine 30 mL
Levobupivacaine 0.25% 30 mL in adductor canal nerve block

Locations

Country	Name	City	State
Chile	Division de Anestesia - Pontificia Universidad Catolica de Chile	Santiago	Region Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

References & Publications (25)

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Jaeger P, Grevstad U, Henningsen MH, Gottschau B, Mathiesen O, Dahl JB. Effect of adductor-canal-blockade on established, severe post-operative pain after total knee arthroplasty: a randomised study. Acta Anaesthesiol Scand. 2012 Sep;56(8):1013-9. doi: 10.1111/j.1399-6576.2012.02737.x. Epub 2012 Jul 26. — View Citation

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Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. Adductor canal block versus femoral nerve block and quadriceps strength: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 10.1097/ALN.0b013e318279fa0b. — View Citation

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Kwofie MK, Shastri UD, Gadsden JC, Sinha SK, Abrams JH, Xu D, Salviz EA. The effects of ultrasound-guided adductor canal block versus femoral nerve block on quadriceps strength and fall risk: a blinded, randomized trial of volunteers. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):321-5. doi: 10.1097/AAP.0b013e318295df80. — View Citation

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	Rescue analgesia	Lidocaine 1% bolus through nerve block catheter and opioid use, measured in mg	24 hours and 48 hours after surgery	Yes
Secondary	Patient satisfaction	Using a 5 point scale from 1 (very unsatisfied) to 5 (very satisfied)	48 hours after surgery	No
Secondary	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	Yes
Secondary	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	Yes