To evaluate the surgical stress response in anterior cruciate ligament repair with an adductor canal block versus patient controlled endovenous analgesia.
Full Title of Study: “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 Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: May 2018
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.
- Procedure: Adductor Canal Block
- Continous peripheral nerve block
- Device: Morphine Patient Controlled Analgesia
- Morphine Patient Controlled Analgesia Delivery System
Arms, Groups and Cohorts
- 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.
- 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.
Clinical Trial Outcome Measures
- 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.
- 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.
- Change of Glycemia from baseline to 24 hours
- Time Frame: 24 hours
- Glycemia will be evaluated preoperatively, 2 hours and 24 hours postoperatively.
Participating in This Clinical Trial
- 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
Gender Eligibility: Male
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Pontificia Universidad Catolica de Chile
- Provider of Information About this Clinical Study
- Overall Official(s)
- Fernando Altermatt, MD, Principal Investigator, PUC
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