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

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.

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Injury
• Intervention / Treatment: Drug: Ropivacaine injection; Drug: Ropivacaine injection

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: IPACK block; Saphenous nerve block and IPACK block by anesthetist under ultrasound guidance.	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).; Drug: Ropivacaine injection; Periarticular infiltration of 80 ml ropivacaine 0.2% (total dose of 160mg).
ACTIVE_COMPARATOR: Local infiltration analgesia; Periarticular infiltration by surgeon	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).; Drug: Ropivacaine injection; Periarticular infiltration of 80 ml ropivacaine 0.2% (total dose of 160mg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total morphine consumption (mg)	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total morphine consumption (mg)		2 hours, 48 hours and 72 hours postoperatively
Active flexion	Flexion of the knee by the patient measured in degrees	24hours, 48hours and 72hours postoperatively
Quadriceps muscle strength (numeric scale, 1-5)	1=no contraction, 5=normal strength	24hours, 48hours and 72hours postoperatively
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
Rate of postoperative nausea and vomiting	Yes/No	2hours, 24hours, 48hours and 72hours postoperatively
Rate of antiemetic consumption	Yes/No	2hours, 24hours, 48hours and 72hours postoperatively
Rate of pruritus	Yes/No	2hours, 24hours, 48hours and 72hours postoperatively
Distance walked (meters)		24 hours, 48hours and 72hours postoperatively
Anterior Cruciate Ligament - Return to Sport after Injury survey		4 and 8 postoperative months
International Knee Documentation Committee score		4 and 8 postoperative months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois

Publications and helpful links

General Publications

• Martin R, Kirkham KR, Ngo THN, Gonvers E, Lambert J, Albrecht E. Combination of femoral triangle block and infiltration between the popliteal artery and the capsule of the posterior knee (iPACK) versus local infiltration analgesia for analgesia after anterior cruciate ligament reconstruction: a randomized controlled triple-blinded trial. Reg Anesth Pain Med. 2021 Sep;46(9):763-768. doi: 10.1136/rapm-2021-102631. Epub 2021 May 26.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2018
• Primary Completion (ACTUAL): October 1, 2020
• Study Completion (ACTUAL): October 1, 2020

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (ACTUAL): September 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Rupture; Anterior Cruciate Ligament Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: CER 2018-01163

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No