Effectiveness of Analgesia in Total Knee Arthroplasty

Pain Clinical Trial

— ATR-2011  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304212
• Other study ID #: ATR-2011
• Status: Completed
• Phase: Phase 4
• First received: February 24, 2011
• Last updated: August 27, 2014
• Start date: April 2011
• Est. completion date: February 2014

Study information

• Verified date: August 2014
• Source: Consorci Sanitari de Terrassa
• Contact: n/a
• Is FDA regulated: No
• Health authority: SPAIN: Spanish Agency of the drug and medical device
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 66 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

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
• 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
• 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)
• 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.

Locations

Country	Name	City	State
Spain	Consorci Sanitari de Terrassa	Terrassa	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Jose Antonio Bernia Gil

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain	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	48 hours postoperatively	No