NCT03680716

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

1.9 years

First QC Date

September 20, 2018

Last Update Submit

January 26, 2021

Conditions

Postoperative PainAnterior Cruciate Ligament InjuryAnterior Cruciate Ligament Rupture

Outcome Measures

Primary Outcomes (1)

  • Total morphine consumption (mg)

    24 hours postoperatively

Secondary Outcomes (10)

  • Total morphine consumption (mg)

    2 hours, 48 hours and 72 hours postoperatively

  • Pain scores (numeric rating scale, 0-10) at rest and on movement

    2hours, 24hours, 48hours and 72hours postoperatively

  • Rate of postoperative nausea and vomiting

    2hours, 24hours, 48hours and 72hours postoperatively

  • Rate of antiemetic consumption

    2hours, 24hours, 48hours and 72hours postoperatively

  • Rate of pruritus

    2hours, 24hours, 48hours and 72hours postoperatively

  • +5 more secondary outcomes

Study Arms (2)

IPACK block

EXPERIMENTAL

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

Drug: Ropivacaine injection

Local infiltration analgesia

ACTIVE COMPARATOR

Periarticular infiltration by surgeon

Drug: Ropivacaine injection

Interventions

Ropivacaine injectionDRUG

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

IPACK block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Statut ASA I-III.
  • Patient scheduled for anterior crutiate ligament reconstruction under general anesthesia.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 34039734DERIVED

MeSH Terms

Conditions

Pain, PostoperativeAnterior Cruciate Ligament Injuries

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsKnee InjuriesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program director of regional anaesthesia

Study Record Dates

First Submitted

September 20, 2018

First Posted

September 21, 2018

Study Start

November 1, 2018

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

January 27, 2021

Record last verified: 2021-01

Locations

CH(1)