Selective Tibial Nerve Block vs Local Infiltration Analgesia After Prothetic Knee Surgery

Postoperative Pain Clinical Trial

Official title:

Optimal Pain Control After Prothetic Knee Surgery Either by Selective Tibial Nerve Block Versus Local Infiltration Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03698006
• Other study ID #: CER 2018-01080
• Status: Completed
• Phase: N/A
• Start date: February 12, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2022
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patient suffer from moderate posterior knee pain after TKA despite injection of local anesthetic around the femoral or saphenous nerves. Indeed, the posterior part of the knee is innervated by the sciatic nerve. This nerve is not routinely blocked as clinicians fear to produce a motor block of the leg that might impair the postoperative assessment. An analgesic alternative is the infiltration of the knee with local anesthetics performed by the surgeon. Recently a trial(1) demonstrated that a selective tibial nerve block provides an effective analgesia without a motor blockage when compared with a sciatic nerve block. The objective of this randomized controlled double-blinded trial is to assess whether a tibial nerve block is more effective for the postoperative pain than local infiltration analgesia when there are combined with an adductor canal block, without decreasing the functional parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient scheduled for a total knee arthroplasty under spinal block.
• Patient with a weight above 40kg.

Exclusion Criteria:

• Patient with ASA IV status.
• Contraindication to spinal block, or peripheral nerve blocks.
• Neurological deficit of the lower limb.
• Patient with renal dysfunction.
• Patient with chronic pain, opioid consumption or alcohol consumption.
• Pregnancy.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Postoperative Pain

Intervention

Drug:
• Ropivacaine 0.5% Injectable Solution
Tibial nerve block with 10ml of Ropivacaine 0.5%
• Ropivacaine 0.2% Injectable Solution
Infiltration with 25ml of Ropivacaine 0.2% in the posterior knee capsule

Locations

Country	Name	City	State
Switzerland	Eric Albrecht	Lausanne	English

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Sinha SK, Abrams JH, Arumugam S, D'Alessio J, Freitas DG, Barnett JT, Weller RS. Femoral nerve block with selective tibial nerve block provides effective analgesia without foot drop after total knee arthroplasty: a prospective, randomized, observer-blinded study. Anesth Analg. 2012 Jul;115(1):202-6. doi: 10.1213/ANE.0b013e3182536193. Epub 2012 Apr 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine consumption (mg)		24 hours postoperatively
Secondary	Total morphine consumption (mg)		2 hours, 48 hours and 72 hours postoperatively
Secondary	Analgesic duration (minutes)	Time from the block to the first analgesic request	Postoperative day 0
Secondary	Pain scores (numeric rating scale, 0-10) at rest and on movement	0= no pain, 10=the worst pain imaginable	2 hours, 24 hours, 48 hours and 72 hours postoperatively
Secondary	Rate of postoperative nausea and vomiting	Yes/No	2 hours, 24 hours, 48 hours and 72 hours postoperatively
Secondary	Rate of prurit	Yes/No	2 hours, 24 hours, 48 hours and 72 hours postoperatively
Secondary	Active flexion	Flexion of the knee by the patient measured in degrees	24hours, 48hours and 72hours postoperatively
Secondary	Passive flexion	Flexion of the knee by physiotherapist measured in degrees	24hours, 48hours and 72hours postoperatively
Secondary	Quadriceps muscle strength (numeric scale, 1-5)	1=no contraction, 5=normal strength	24hours, 48hours and 72hours postoperatively
Secondary	Distance walked (meters)		24hours, 48hours and 72hours postoperatively
Secondary	Complication of tibial nerve block	Intravascular injection/hematoma/infection/Common peroneal nerve block	up to 1 week
Secondary	Length of stay in hospital	Days	up to 14 days