Effectiveness of Analgesia in Total Knee Arthroplasty

Overview

The purpose of this study is to compare the analgesic effectiveness of three techniques: the femoral nerve block, intraarticular infiltration or a combination of both in the control of pain in total knee arthroplasty (KA). The hypothesis to be tested in this study is that the performance multimodal postoperative pain KA combining two analgesic techniques to obtain better analgesia than when applied separately.

Full Title of Study: “Comparison of the Analgesic Effect of Femoral Nerve Block, Intraarticular Infiltration or a Combination of Both in the Control of Pain in Total Knee Arthroplasty”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: February 2014

Interventions

  • Drug: several drugs: morphine chloride,ropivacaine,epinephrine,ketorolac
    • This technique is performed intraoperatively with a 100 ml solution containing: 225 mg of ropivacaine 1% (22.5 ml) + 5 mg of morphine chloride 0.1% (5ml) + 30 mg of epinephrine 1:1000 (0.3 ml ) + ketorolac 30mg (1ml) +71 ml of 0.9% saline
  • Drug: ropivacaine,morphine chloride,epinephrine,ketorolac
    • This technique is performed intraoperatively with a 100 ml solution containing: 225 mg of ropivacaine 1% (22.5 ml) + 5 mg of morphine chloride 0.1% (5ml) + 30 mg of epinephrine 1:1000 (0.3 ml ) + ketorolac 30mg (1ml) +71 ml of 0.9% saline
  • Drug: ropivacaine
    • The lock is held before starting the operation, viewing with ultrasound and confirmed the femoral nerve with nerve stimulation at an intensity of 0.5 mA and a frequency of 2 Hz Pajunk 50mm needle, patellar flexion. It be administered 30ml of ropivacaine 0.75% (225mg)
  • Drug: morphine ,ketorolac
    • ultrasound-assisted femoral nerve block is performed and leaks intraoperatively with a 100 ml solution containing: 5 mg of morphine to 0.1% (5ml) +30 mg of ketorolac (1 ml) +96 ml of 0.9% saline.

Arms, Groups and Cohorts

  • Active Comparator: femoral block
  • Experimental: local infiltration + femoral nerve block
    • Combination of local infiltration with drugs and femoral nerve block
  • Active Comparator: several drugs local infiltration

Clinical Trial Outcome Measures

Primary Measures

  • postoperative pain
    • Time Frame: 48 hours postoperatively
    • Is measured at the time of starting rehabilitation, postoperatively 48 hours using visual analog scale, numerical and categorical verbal pain scale at 12,24 and 48 hours

Participating in This Clinical Trial

Inclusion Criteria

  • intervention program for total knee arthroplasty
  • ASA I, II, III
  • over 65 years old

Exclusion Criteria

  • ASA > III
  • patients who refuse the realization of technical loco-regional anesthesia
  • presence of coagulopathy or impaired hemostatic function
  • BMI > 35
  • Serious intraoperative complications
  • patients undergoing bypass and aortic-femoral or femoro popliteal bypass operated leg
  • patients treated for chronic pain diagnosed processes, different knee osteoarthritis

Gender Eligibility: All

Minimum Age: 66 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jose Antonio Bernia Gil
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Jose Antonio Bernia Gil, PhD,MD – Consorci Sanitari de Terrassa
  • Overall Official(s)
    • José Antonio Bernia Gil, MD, PhD, Principal Investigator, Consorci Sanitari de Terrassa

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