Stimulating Catheter for Lumbar Plexus Block: Better Postoperative Analgesia?

Hip Replacement Arthroplasty Clinical Trial

Official title:

Stimulating Catheter for Lumbar Plexus Block: Better Postoperative Analgesia?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02162121
• Other study ID #: IOGPGC06-14
• Status: Completed
• Phase: Phase 4
• First received: June 9, 2014
• Last updated: August 11, 2017
• Start date: May 2014
• Est. completion date: October 2016

Study information

• Verified date: August 2017
• Source: ASST Gaetano Pini-CTO
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Stimulating catheters have been introduced to reduce the incidence of secondary failure after continuous peripheral nerve blocks, but they effectiveness over traditional nonstimulating catheters is still controversial. The aim of this prospective, randomized, blinded study is to detect if stimulating catheters improve postoperative compared with conventional non-stimulating catheters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients undergoing total hip arthroplasty

Exclusion Criteria:

• diabetes neurological disorders coagulation disorders rheumatoid arthritis chronic opioids therapy allergy to local anesthetic

Related Conditions & MeSH terms

• Hip Replacement Arthroplasty

Intervention

Procedure:
• Continuous lumbar plexus: stimulating catheter
Perinervous stimulating catheter ("Stimulong", "Pajunk", Germany) will be insert in lumbar plexus through tuohy needle (18G, 100mm length). 15ml mepivacaine 1% are injected before the complete resolution of the spinal anesthesia.
• Spinal Anesthesia
Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 15mg will be injected.
• Local anesthetic infusion
Continuous infusion (Mini Rythmic Evolution, Micrel) of ropivacaine 0,2% at 3ml/h, bolus 3 ml, lockout time 15 min, 12 ml/h maximum dose through perinervous catheter until 3rd postoperative day
• Intravenous analgesia
Ketorolac 30mg 3 times a day
• Opioids rescue analgesia
Buprenorphine 0,2mg twice a day if VAS>4

Drug:
• Mepivacaine 1%

• Levobupivacaine 0,5%

• Ropivacaine 0,2%

• Ketorolac 30mg

• Buprenorphine 0,2mg

Device:
• Stimulong, Pajunk, Germany.

Procedure:
• Continuous lumbar plexus: non-stimulating catheter

Locations

Country	Name	City	State
Italy	Istituto ortopedico Gaetano Pini	Milan

Sponsors (1)

Lead Sponsor	Collaborator
ASST Gaetano Pini-CTO

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local anesthetic consumption	Evaluation of local anesthesic consumption every 6h in first 72 postoperative hours.	72h
Secondary	Visual Analog scale (VAS) score	Evaluation of VAS static and VAS dynamic during first 72 postoperative hours	72h postoperatively
Secondary	Up and Go test	"up and go" test: time need to get up from a chair, walk for 3 meters, and come back to seat down on the chair	4th postoperative day
Secondary	Opioids request	Opioids consumption will be recorded throughout 72 postoperative hours	72h postoperatively
Secondary	Quadriceps strength	evaluate bilateral muscle strength with an isometric force dynamometer to measure the force produced during a maximum voluntary isometric contraction in a lying position by the knee flex to 90°.	preoperative and 24h, 48h, 72h postoperatively
Secondary	postoperative nausea and vomiting (PONV)	Evaluation of nausea and vomit incidence in postoperative period with scale 0 from 4	72h postoperatively
Secondary	Needle redirections	During catheter positioning number of needle redirections necessary to found lumbar plexus are recorder.	During catheter position
Secondary	Catheter insertion time	Time (minutes) needed for catheter placement	During catheter positioning