Ropivacaine and Midazolam by Intraarticular vs Epidural Administration in Arthroscopic ACL

• Status: Completed
• Trial end date: 2021-02-05
• Target enrollment: 0
• Participant gender: All

Summary

Compare of the effectiveness of the use of ropivacaine and midazolam by intraarticular vs epidural administration on post-operative analgesia after isolated arthroscopic anterior cruciate ligament (ACL) reconstruction with hamstring autograft.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad Autonoma de Nuevo Leon
• Collaborator: Universitat Autonoma de Barcelona
• Treatments: Midazolam; Ropivacaine

Criteria

Inclusion Criteria:

1. Age over 18 years and younger than 50 years

2. Arthroscopic single bundle anterior cruciate ligament anatomic reconstruction with hamstring tendon autograft

3. Unilateral procedure

4. With or without meniscal tear

5. Desire to participate voluntarily in the study and signature of informed consent

6. Pre-operative assessment with result between (American Society of Anesthesiologist) ASA I or ASA II performed and annexed in the clinical file either by the Department of Internal Medicine, Cardiology or Anesthesiology.

Exclusion Criteria:

1. Another ligament surgery (posterior cruciate ligament, medial collateral ligament, posterolateral corner reconstruction)

2. ACL reconstruction with allograft

3. Bone to bone or quadriceps autograft

4. ACL reconstruction with double bundle technique

5. Patients with previous knee surgeries

6. Open ACL reconstruction

7. Corrective knee osteotomy or articular cartilage repair surgery, meniscal transplant, lateral extraarticular tenodesis

8. Pregnant or lactating patients

9. Patients under 18 years old

10. Patients consuming oral contraceptives

11. Patients who present any contraindication for neuraxial blockade (e.g., coagulation defects, infection at the puncture site, pre-existing neurological deficits in the lower extremities, Anticoagulant or antiplatelet therapy that has not been suspended 48 hours before the surgery, systemic infection, fever above 38.5º)

12. Preoperative assessment with ASA III-IV

13. Hypersensitivity to the drugs used in the study

14. Patients with intellectual impairments or psychiatric conditions that limited adequate communication

15. Patients with a diagnosis of fibromyalgia, polymyalgia rheumatica, complex painful syndromes or sciatic neuropathy