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

Phase 1

Withdrawn

• Conditions: Anesthesia; Surgery; Stress, Physiological
• Interventions: Device: Morphine Patient Controlled Analgesia; Procedure: Adductor Canal Block

• Registration Number: NCT04797546
• Lead Sponsor: Pontificia Universidad Catolica de Chile

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 Timeline

• Status Verified: 2016-09
• Study Start: 2016-09
• Study First Submitted: 2016-09-12
• Primary Completion: 2018-05
• Study Completion: 2018-11
• Study First Submitted QC: 2021-03-11
• Last Update Submitted: 2021-03-11
• Study First Posted: 2021-03-15
• Last Update Posted: 2021-03-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient Controlled Morphine Analgesia	Morphine Patient Controlled 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.
Adductor Canal Block	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change of Glycemia from baseline to 24 hours	24 hours	Glycemia will be evaluated preoperatively, 2 hours and 24 hours postoperatively.
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.

Trial Locations

Locations (1)

Pontificia Universidad Católica de Chile; 🇨🇱 Santiago, Chile