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

Sponsor
Pontificia Universidad Catolica de Chile (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04797546
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
26
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Adductor Canal Block
  • Device: Morphine Patient Controlled Analgesia
 Phase 1

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
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Sep 1, 2016
Anticipated Primary Completion Date :
May 1, 2018
Anticipated Study Completion Date :
Nov 1, 2018

Arms and Interventions

Arm Intervention/Treatment
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.

Procedure: Adductor Canal Block
Continous peripheral nerve block
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.

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change of Blood Cortisol from baseline to 24 hours [24 hours]

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

    Secondary Outcome Measures

    1. Change of C Reactive Protein from baseline to 24 hours [24 hours]

      C Reactive Protein will be evaluated preoperatively, 2 hours and 24 hours postoperatively.

    2. Change of Glycemia from baseline to 24 hours [24 hours]

      Glycemia will be evaluated preoperatively, 2 hours and 24 hours postoperatively.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pontificia Universidad Católica de Chile Santiago Chile

    Sponsors and Collaborators

    • Pontificia Universidad Catolica de Chile

    Investigators

    • Principal Investigator: Fernando Altermatt, MD, PUC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Pontificia Universidad Catolica de Chile
    ClinicalTrials.gov Identifier:
    NCT04797546
    Other Study ID Numbers:
    • 16-128
    First Posted:
    Mar 15, 2021
    Last Update Posted:
    Mar 15, 2021
    Last Verified:
    Sep 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Morphine

    Study Results

    No Results Posted as of Mar 15, 2021