Addition of Popliteal Plexus Block to Continuous Femoral Nerve Block for Total Knee Arthroplasty

Pain, Postoperative Clinical Trial

Official title:

Addition of Popliteal Plexus Block to Continuous Femoral Nerve Block for Total Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04048889
• Other study ID #: 2019-00655
• Status: Recruiting
• Phase: N/A
• Start date: July 22, 2019
• Est. completion date: July 1, 2022

Study information

• Verified date: August 2019
• Source: University Hospital, Geneva
• Contact: Kevin Stebler, MD
• Phone: 0041795532149
• Email: kevin.stebler[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The popliteal plexus block has been described as an alternative analgesic postoperative pain treatment for total knee arthroplasty. It consists of injecting local anaeshetics inside the distal end of the adductor canal close to the adductor hiatus, adjacent to the femoral artery, between the medial vastus muscle and the adductor magnus muscle, in order to anesthetize the popliteal plexus. However, the analgesic efficacy has never been demonstrated in a randomized controlled trial. Therefore the objective of this study is to investigate the analgesic benefit of this block combined with a continuous femoral nerve block, on patients scheduled for total knee athroplasty.

Description:

Patients scheduled to undergo total knee arthroplasty under general anesthesia will be randomly allocated to two groups: continuous femoral nerve block alone or continuous femoral nerve block with addition of a popliteal plexus block.

The continuous femoral nerve block will be performed by the anesthesiologist with 15 mLs of ropivacaine 0.5%, under ultrasound guidance before the beginning of the general anesthesia. The popliteal plexus block will be done by the anesthesiology, under ultrasound guidance, before the beginning of the surgery, under general anesthesia.

Postoperative analgesia will include acetaminophen (4 x 1000 mg), ibuprofen (3 x 400 mg) and a continuous infusion of Ropivacaine 0.2%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: July 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients scheduled for total knee athroplasty under general anesthesia

• ASA 1-3

Exclusion Criteria:

• Kidney disease with GFR < 50 ml/mn

• Daily opioid consumption > 1 month

• Allergy to local anesthetics

• Neurological problems of the lower extremity

• other contraindications to peripheral nerve blocks

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Ropivacaine 0.5% Injectable Solution
Continuous femoral nerve block with injection of 15 mls of Ropivacain 0.5% adjacent to the lateral aspect of the femoral nerve below the fascia iliaca and placement of the catheter within the vicinity of the femoral nerve, juste deep to the fascia iliaca
• Ropivacaine 0.5% Injectable Solution
Continuous femoral nerve block with injection of 15 mls of Ropivacain 0.5% adjacent to the lateral aspect of the femoral nerve below the fascia iliaca and placement of the catheter within the vicinity of the femoral nerve, juste deep to the fascia iliaca.
• Ropivacaine 0.5% Injectable Solution
Popliteal plexus block with injection of 15 mls of Ropivacain 0.5% inside the distal end of the adductor canal close to the adductor hiatus, adjacent to the femoral artery, between the medial vastus muscle and the adductor Magnus muscle, done under general anesthesia.

Locations

Country	Name	City	State
Switzerland	Departement of Anesthesia, Hôpitaux Universitaires de Genève	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total iv morphine consumption (mg)		12 postoperative hours
Secondary	Total iv morphine consumption (mg)		24 and 48 postoperative hours
Secondary	Average and maximum pain scores (Numeric rating scale 0-10)		12, 24 and 48 postoperative hours
Secondary	Sciatic extension of popliteal plexus block	Presence of sensitive or/and motor sciatic extension of popliteal plexus block	2 and 24 postoperative hours
Secondary	Plantarflexion and dorsiflexion ankle strength (Newtons)		2 and 24 postoperative hours
Secondary	Knee pain localization (anterior, internal, posterior, lateral, medial)		2, 12, 24 and 48 postoperative hours
Secondary	Popliteal plexus block procedure time (minutes)	Onset of action = beginning of the disinfection; End of action = end of injection of 15 mls of Ropivacain 0.5%	When performing the popliteal plexus block
Secondary	Popliteal plexus block duration of action (hours)	Onset of action = Time from end of infection of 15 mls of Ropivacain 0.5%; End of action = onset of lateral and/or posterior knee pain (With Numeric rating scale = 4)	up to 48 postoperative hours