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

NCT ID: NCT03698006

Last Updated: 2022-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-12
• Study Completion Date: 2022-06-30

Brief 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.

Conditions

Postoperative Pain; Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Tibial nerve block

Adductor canal and tibial nerve blocks performed by the anesthetist under ultrasound guidance before spinal block.

Group Type: EXPERIMENTAL

Ropivacaine 0.5% Injectable Solution

Intervention Type: DRUG

Tibial nerve block with 10ml of Ropivacaine 0.5%

Local infiltration analgesia

Adductor canal block by the anesthetist under ultrasound guidance before spinal block. Infiltration of the knee by the surgeon with local anesthetic at the end of the surgery.

Group Type: ACTIVE_COMPARATOR

Ropivacaine 0.2% Injectable Solution

Intervention Type: DRUG

Infiltration with 25ml of Ropivacaine 0.2% in the posterior knee capsule

Interventions

Ropivacaine 0.5% Injectable Solution

Tibial nerve block with 10ml of Ropivacaine 0.5%

Intervention Type: DRUG

Ropivacaine 0.2% Injectable Solution

Infiltration with 25ml of Ropivacaine 0.2% in the posterior knee capsule

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

Eric Albrecht

Program director of regional anaesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Eric Albrecht

Lausanne, English, Switzerland

Countries

Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 22543069 (View on PubMed)

Other Identifiers

CER 2018-01080

Identifier Type: -

Identifier Source: org_study_id