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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04797546
• Other study ID #: 16-128
• Status: Withdrawn
• Phase: Phase 1
• Start date: September 2016
• Est. completion date: November 2018

Study information

• Verified date: September 2016
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Stress, Physiological
• Surgery

Intervention

Procedure:
• Adductor Canal Block
Continous peripheral nerve block

Device:
• Morphine Patient Controlled Analgesia
Morphine Patient Controlled Analgesia Delivery System

Locations

Country	Name	City	State
Chile	Pontificia Universidad Católica de Chile	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

References & Publications (11)

Ahlers O, Nachtigall I, Lenze J, Goldmann A, Schulte E, Höhne 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. — View Citation

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. — View Citation

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. — View Citation

Desborough JP. The stress response to trauma and surgery. Br J Anaesth. 2000 Jul;85(1):109-17. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Weissman C. The metabolic response to stress: an overview and update. Anesthesiology. 1990 Aug;73(2):308-27. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Blood Cortisol from baseline to 24 hours	Blood Cortisol will be evaluated preoperatively, 2 hours and 24 hours postoperatively.	24 hours
Secondary	Change of C Reactive Protein from baseline to 24 hours	C Reactive Protein will be evaluated preoperatively, 2 hours and 24 hours postoperatively.	24 hours
Secondary	Change of Glycemia from baseline to 24 hours	Glycemia will be evaluated preoperatively, 2 hours and 24 hours postoperatively.	24 hours