NCT04797546

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
Last Updated

March 15, 2021

Status Verified

September 1, 2016

Enrollment Period

1.7 years

First QC Date

September 12, 2016

Last Update Submit

March 11, 2021

Conditions

AnesthesiaStress, PhysiologicalSurgery

Outcome Measures

Primary Outcomes (1)

  • Change of Blood Cortisol from baseline to 24 hours

    Blood Cortisol will be evaluated preoperatively, 2 hours and 24 hours postoperatively.

    24 hours

Secondary Outcomes (2)

  • Change of C Reactive Protein from baseline to 24 hours

    24 hours

  • Change of Glycemia from baseline to 24 hours

    24 hours

Study Arms (2)

Adductor Canal Block

EXPERIMENTAL

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.

Procedure: Adductor Canal Block

Patient Controlled Morphine Analgesia

ACTIVE COMPARATOR

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.

Device: Morphine Patient Controlled Analgesia

Interventions

Adductor Canal BlockPROCEDURE

Continous peripheral nerve block

Adductor Canal Block
Morphine Patient Controlled AnalgesiaDEVICE

Morphine Patient Controlled Analgesia Delivery System

Also known as: Patient Controlled Analgesia
Patient Controlled Morphine Analgesia

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male,
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pontificia Universidad Católica de Chile

Santiago, Chile

Location

Related Publications (11)

  • 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.

    PMID: 10927999BACKGROUND

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

    PMID: 2200312BACKGROUND

  • 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.

    PMID: 10655907BACKGROUND

  • 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.

    PMID: 21108620BACKGROUND

  • 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.

    PMID: 18922851BACKGROUND

  • 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.

    PMID: 23295713BACKGROUND

  • 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.

    PMID: 18155052BACKGROUND

  • 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.

    PMID: 18211990BACKGROUND

  • 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.

    PMID: 18719447BACKGROUND

  • 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.

    PMID: 20887928BACKGROUND

  • 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.

    PMID: 24074810BACKGROUND

MeSH Terms

Interventions

Analgesia, Patient-Controlled

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and Analgesia

Study Officials

  • Fernando Altermatt, MD

    PUC

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2016

First Posted

March 15, 2021

Study Start

September 1, 2016

Primary Completion

May 1, 2018

Study Completion

November 1, 2018

Last Updated

March 15, 2021

Record last verified: 2016-09

Locations

CL(1)