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

Primary Purpose

Postoperative Pain, Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Rupture

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Ropivacaine injection
Ropivacaine injection
Sponsored by
Centre Hospitalier Universitaire Vaudois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IPACK block

Local infiltration analgesia

Arm Description

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

Periarticular infiltration by surgeon

Outcomes

Primary Outcome Measures

Total morphine consumption (mg)

Secondary Outcome Measures

Total morphine consumption (mg)
Pain scores (numeric rating scale, 0-10) at rest and on movement
0= no pain, 10=the worst pain imaginable
Rate of postoperative nausea and vomiting
Yes/No
Rate of antiemetic consumption
Yes/No
Rate of pruritus
Yes/No
Active flexion
Flexion of the knee by the patient measured in degrees
Quadriceps muscle strength (numeric scale, 1-5)
1=no contraction, 5=normal strength
Distance walked (meters)
Anterior Cruciate Ligament - Return to Sport after Injury survey
International Knee Documentation Committee score

Full Information

First Posted
September 20, 2018
Last Updated
January 26, 2021
Sponsor
Centre Hospitalier Universitaire Vaudois
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1. Study Identification

Unique Protocol Identification Number
NCT03680716
Brief Title
Combined Saphenous Nerve and IPACK Blocks Versus Infiltration Analgesia After Anterior Cruciate Ligament Reconstruction
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Rupture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IPACK block
Arm Type
Experimental
Arm Description
Saphenous nerve block and IPACK block by anesthetist under ultrasound guidance.
Arm Title
Local infiltration analgesia
Arm Type
Active Comparator
Arm Description
Periarticular infiltration by surgeon
Intervention Type
Drug
Intervention Name(s)
Ropivacaine injection
Intervention Description
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
Intervention Name(s)
Ropivacaine injection
Intervention Description
Periarticular infiltration of 80 ml ropivacaine 0.2% (total dose of 160mg).
Primary Outcome Measure Information:
Title
Total morphine consumption (mg)
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Total morphine consumption (mg)
Time Frame
2 hours, 48 hours and 72 hours postoperatively
Title
Pain scores (numeric rating scale, 0-10) at rest and on movement
Description
0= no pain, 10=the worst pain imaginable
Time Frame
2hours, 24hours, 48hours and 72hours postoperatively
Title
Rate of postoperative nausea and vomiting
Description
Yes/No
Time Frame
2hours, 24hours, 48hours and 72hours postoperatively
Title
Rate of antiemetic consumption
Description
Yes/No
Time Frame
2hours, 24hours, 48hours and 72hours postoperatively
Title
Rate of pruritus
Description
Yes/No
Time Frame
2hours, 24hours, 48hours and 72hours postoperatively
Title
Active flexion
Description
Flexion of the knee by the patient measured in degrees
Time Frame
24hours, 48hours and 72hours postoperatively
Title
Quadriceps muscle strength (numeric scale, 1-5)
Description
1=no contraction, 5=normal strength
Time Frame
24hours, 48hours and 72hours postoperatively
Title
Distance walked (meters)
Time Frame
24 hours, 48hours and 72hours postoperatively
Title
Anterior Cruciate Ligament - Return to Sport after Injury survey
Time Frame
4 and 8 postoperative months
Title
International Knee Documentation Committee score
Time Frame
4 and 8 postoperative months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34039734
Citation
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.
Results Reference
derived

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

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