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Clinical Trials/NCT04797546
NCT04797546WithdrawnPhase 1

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

Pontificia Universidad Catolica de Chile1 site in 1 countryStarted: September 2016Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Withdrawn
Locations
1
Primary Endpoint
Change of Blood Cortisol from baseline to 24 hours

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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 Outcomes

  • Change of Glycemia from baseline to 24 hours(24 hours)
  • Change of C Reactive Protein from baseline to 24 hours(24 hours)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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