Adductor Canal Block Versus Patient Controlled Analgesia, in the Surgical Stress Response for Anterior Cruciate Ligament Repair

Overview

To evaluate the surgical stress response in anterior cruciate ligament repair with an adductor canal block versus patient controlled endovenous analgesia.

Full Title of Study: “Impact of Adductor Canal Block, Compared to Patient Controlled Analgesia, in the Surgical Stress Response of Patients Programmed for Traumatic Anterior Cruciate Ligament Repair”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2018

Detailed Description

Preoperative, 2 hours and 24 hours stress biomarkers will be evaluated in two groups of patients, continous adductor canal block and morphine patient controlled endovenous analgesia.

Interventions

  • Procedure: Adductor Canal Block
    • Continous peripheral nerve block
  • Device: Morphine Patient Controlled Analgesia
    • Morphine Patient Controlled Analgesia Delivery System

Arms, Groups and Cohorts

  • Experimental: Adductor Canal Block
    • With mild sedation, a continous bupivacaine 0.1% infusion catheter is placed in the adductor canal. Afterwards, patients are placed under General Anesthesia, and surgery starts. Preoperative, 2 hours and 24 hours stress biomarkers and analgesic quality will be measured.
  • Active Comparator: Patient Controlled Morphine Analgesia
    • Patients are placed under General Anesthesia, and after surgery, a Morphine patient controlled analgesia delivery system is installed. Preoperative, 2 hours and 24 hours stress biomarkers and analgesic quality will be measured.

Clinical Trial Outcome Measures

Primary Measures

  • Change of Blood Cortisol from baseline to 24 hours
    • Time Frame: 24 hours
    • Blood Cortisol will be evaluated preoperatively, 2 hours and 24 hours postoperatively.

Secondary Measures

  • Change of C Reactive Protein from baseline to 24 hours
    • Time Frame: 24 hours
    • C Reactive Protein will be evaluated preoperatively, 2 hours and 24 hours postoperatively.
  • Change of Glycemia from baseline to 24 hours
    • Time Frame: 24 hours
    • Glycemia will be evaluated preoperatively, 2 hours and 24 hours postoperatively.

Participating in This Clinical Trial

Inclusion Criteria

  • Male, – 18-65 years, – traumatic Anterior Cruciate Ligament tear, scheduled for elective arthroscopic repair with Semitendinous-Gracillis technique at first time in the morning, with full articular range, – no other traumatologic lesions. Exclusion Criteria:

  • denied consent to participate, – chronic steroids user, – diabetes type 1 or 2, – insulin resistance, – concurrent infectious disease, – cognitive failure, coagulopathy, – allergy to study drugs, – surgery scheduled in the afternoon

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Pontificia Universidad Catolica de Chile
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Fernando Altermatt, MD, Principal Investigator, PUC

References

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Richardson J, Sabanathan S, Jones J, Shah RD, Cheema S, Mearns AJ. A prospective, randomized comparison of preoperative and continuous balanced epidural or paravertebral bupivacaine on post-thoracotomy pain, pulmonary function and stress responses. Br J Anaesth. 1999 Sep;83(3):387-92.

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Fant F, Tina E, Sandblom D, Andersson SO, Magnuson A, Hultgren-Hörnkvist E, Axelsson K, Gupta A. Thoracic epidural analgesia inhibits the neuro-hormonal but not the acute inflammatory stress response after radical retropubic prostatectomy. Br J Anaesth. 2013 May;110(5):747-57. doi: 10.1093/bja/aes491. Epub 2013 Jan 7.

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Fowler SJ, Symons J, Sabato S, Myles PS. Epidural analgesia compared with peripheral nerve blockade after major knee surgery: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2008 Feb;100(2):154-64. doi: 10.1093/bja/aem373. Review.

Martin F, Martinez V, Mazoit JX, Bouhassira D, Cherif K, Gentili ME, Piriou P, Chauvin M, Fletcher D. Antiinflammatory effect of peripheral nerve blocks after knee surgery: clinical and biologic evaluation. Anesthesiology. 2008 Sep;109(3):484-90. doi: 10.1097/ALN.0b013e318182c2a1.

Cuellar VG, Cuellar JM, Golish SR, Yeomans DC, Scuderi GJ. Cytokine profiling in acute anterior cruciate ligament injury. Arthroscopy. 2010 Oct;26(10):1296-301. doi: 10.1016/j.arthro.2010.02.011.

Sharma A, Aoun P, Wigham J, Weist S, Veldhuis JD. Gender determines ACTH recovery from hypercortisolemia in healthy older humans. Metabolism. 2013 Dec;62(12):1819-29. doi: 10.1016/j.metabol.2013.08.014. Epub 2013 Sep 25.

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