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

March 11, 2021 updated by: Pontificia Universidad Catolica de Chile

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile
        • Pontificia Universidad Catolica de Chile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of C Reactive Protein from baseline to 24 hours
Time Frame: 24 hours
C Reactive Protein will be evaluated preoperatively, 2 hours and 24 hours postoperatively.
24 hours
Change of Glycemia from baseline to 24 hours
Time Frame: 24 hours
Glycemia will be evaluated preoperatively, 2 hours and 24 hours postoperatively.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Investigators

  • Principal Investigator: Fernando Altermatt, MD, PUC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ANTICIPATED)

May 1, 2018

Study Completion (ANTICIPATED)

November 1, 2018

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

March 11, 2021

First Posted (ACTUAL)

March 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 15, 2021

Last Update Submitted That Met QC Criteria

March 11, 2021

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-128

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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