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

NCT ID: NCT03680716

Last Updated: 2021-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2020-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postoperative Pain Anterior Cruciate Ligament Injury Anterior Cruciate Ligament Rupture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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IPACK block

Saphenous nerve block and IPACK block by anesthetist under ultrasound guidance.

Group Type EXPERIMENTAL

Ropivacaine injection

Intervention Type DRUG

Saphenous nerve block with 20ml of ropivacaine 0.5% and IPACK block with 30ml of ropivacaine 0.2% (total dose of 160 mg).

Local infiltration analgesia

Periarticular infiltration by surgeon

Group Type ACTIVE_COMPARATOR

Ropivacaine injection

Intervention Type DRUG

Periarticular infiltration of 80 ml ropivacaine 0.2% (total dose of 160mg).

Interventions

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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).

Intervention Type DRUG

Ropivacaine injection

Periarticular infiltration of 80 ml ropivacaine 0.2% (total dose of 160mg).

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role lead

Responsible Party

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Eric Albrecht

Program director of regional anaesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 34039734 (View on PubMed)

Other Identifiers

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CER 2018-01163

Identifier Type: -

Identifier Source: org_study_id

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