Combined Saphenous Nerve and IPACK Blocks Versus Infiltration Analgesia After Anterior Cruciate Ligament Reconstruction

Postoperative Pain Clinical Trial

Official title:

Analgesic Efficacy of a Combined Saphenous Nerve Block and IPACK Block Versus Local Infiltration Analgesia After Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Double-blinded Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03680716
• Other study ID #: CER 2018-01163
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: October 1, 2020

Study information

• Verified date: January 2021
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A lot of patient have posterior knee pain after ACL reconstruction despite saphenous nerve block. Recently a new block has been described, know as IPACK block (interspace between the popliteal artery and the capsule of the posterior knee). The objective of this randomized controlled double-blinded trial is to assess whether a combined saphenous nerve block with IPACK block is more effective for the postoperative pain than a local infiltration analgesia.

Description:

The saphenous nerve and the iPACK will be performed after general anaesthesia induction and before the surgery under ultrasound-guidance.

The local infiltration analgesia will be performed by the surgeon during the surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Statut ASA I-III.

• Patient scheduled for anterior crutiate ligament reconstruction under general anesthesia.

Exclusion Criteria:

• Pregnancy.

• Contraindication to local anesthesia.

• Patient with chronic pain, opioid consumption or alcohol consumption.

• Patient with coagulation trouble, hepatic dysfunction or renal dysfunction.

• Patient with diabetic or femoral neuropathy.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Injury
• Anterior Cruciate Ligament Rupture
• Postoperative Pain
• Rupture

Intervention

Drug:
• Ropivacaine injection
Saphenous nerve block with 20ml of ropivacaine 0.5% and IPACK block with 30ml of ropivacaine 0.2% (total dose of 160 mg).
• Ropivacaine injection
Periarticular infiltration of 80 ml ropivacaine 0.2% (total dose of 160mg).

Locations

Country	Name	City	State
Switzerland	Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

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	Pain scores (numeric rating scale, 0-10) at rest and on movement	0= no pain, 10=the worst pain imaginable	2hours, 24hours, 48hours and 72hours postoperatively
Secondary	Rate of postoperative nausea and vomiting	Yes/No	2hours, 24hours, 48hours and 72hours postoperatively
Secondary	Rate of antiemetic consumption	Yes/No	2hours, 24hours, 48hours and 72hours postoperatively
Secondary	Rate of pruritus	Yes/No	2hours, 24hours, 48hours and 72hours postoperatively
Secondary	Active flexion	Flexion of the knee by the patient 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)		24 hours, 48hours and 72hours postoperatively
Secondary	Anterior Cruciate Ligament - Return to Sport after Injury survey		4 and 8 postoperative months
Secondary	International Knee Documentation Committee score		4 and 8 postoperative months