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

NCT ID: NCT04797546

Last Updated: 2021-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Anesthesia Stress, Physiological Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Adductor Canal Block

Intervention Type PROCEDURE

Continous peripheral nerve block

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.

Group Type ACTIVE_COMPARATOR

Morphine Patient Controlled Analgesia

Intervention Type DEVICE

Morphine Patient Controlled Analgesia Delivery System

Interventions

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Adductor Canal Block

Continous peripheral nerve block

Intervention Type PROCEDURE

Morphine Patient Controlled Analgesia

Morphine Patient Controlled Analgesia Delivery System

Intervention Type DEVICE

Other Intervention Names

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Patient Controlled Analgesia

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fernando Altermatt, MD

Role: PRINCIPAL_INVESTIGATOR

PUC

Locations

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Pontificia Universidad Católica de Chile

Santiago, , Chile

Site Status

Countries

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Chile

References

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Desborough JP. The stress response to trauma and surgery. Br J Anaesth. 2000 Jul;85(1):109-17. doi: 10.1093/bja/85.1.109. No abstract available.

Reference Type BACKGROUND
PMID: 10927999 (View on PubMed)

Weissman C. The metabolic response to stress: an overview and update. Anesthesiology. 1990 Aug;73(2):308-27. doi: 10.1097/00000542-199008000-00020.

Reference Type BACKGROUND
PMID: 2200312 (View on PubMed)

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. doi: 10.1093/bja/83.3.387.

Reference Type BACKGROUND
PMID: 10655907 (View on PubMed)

Hong JY, Yang SC, Yi J, Kil HK. Epidural ropivacaine and sufentanil and the perioperative stress response after a radical retropubic prostatectomy. Acta Anaesthesiol Scand. 2011 Mar;55(3):282-9. doi: 10.1111/j.1399-6576.2010.02360.x. Epub 2010 Nov 25.

Reference Type BACKGROUND
PMID: 21108620 (View on PubMed)

Ahlers O, Nachtigall I, Lenze J, Goldmann A, Schulte E, Hohne C, Fritz G, Keh D. Intraoperative thoracic epidural anaesthesia attenuates stress-induced immunosuppression in patients undergoing major abdominal surgery. Br J Anaesth. 2008 Dec;101(6):781-7. doi: 10.1093/bja/aen287. Epub 2008 Oct 15.

Reference Type BACKGROUND
PMID: 18922851 (View on PubMed)

Fant F, Tina E, Sandblom D, Andersson SO, Magnuson A, Hultgren-Hornkvist 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.

Reference Type BACKGROUND
PMID: 23295713 (View on PubMed)

Bagry H, de la Cuadra Fontaine JC, Asenjo JF, Bracco D, Carli F. Effect of a continuous peripheral nerve block on the inflammatory response in knee arthroplasty. Reg Anesth Pain Med. 2008 Jan-Feb;33(1):17-23. doi: 10.1016/j.rapm.2007.06.398.

Reference Type BACKGROUND
PMID: 18155052 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18211990 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18719447 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20887928 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24074810 (View on PubMed)

Other Identifiers

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16-128

Identifier Type: -

Identifier Source: org_study_id

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