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Effect of LIA on Postoperative Pain Following ACL Reconstruction

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ClinicalTrials.gov Identifier: NCT03873077
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Alain Kalmar, MD, PhD, Algemeen Ziekenhuis Maria Middelares

Brief Summary:

An anterior cruciate ligament (ACL) rupture is one of the most common sport injuries, which typically develops after a sudden knee torsion. Arthroscopic repair of the ACL is often required as a complete ACL tear can cause instability of the knee joint.

During arthroscopic reconstruction the lower leg is reattached to the upper leg using part of the hamstring tendon (mm. gracilis and mm. semitendinosus). Optimal postoperative analgesia is necessary to allow a quick recovery. Intravenous analgesia during surgery is often associated with a number of side effects such as nausea, vomiting and muscle weakness and does not anesthetize the donor site of the hamstring tendon graft. Local infiltration of ropivacaine and lidocaine in the knee joint and at the donor site can be a valuable asset to control the postoperative pain.

This study evaluates the effect of local infiltration analgesia (LIA) on the postoperative pain in the first month after an ACL reconstruction. Half of participants will only receive intravenous analgesia during surgery, the other half will receive intravenous analgesia and a LIA.


Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Rupture Pain, Postoperative Procedure: local infiltration analgesia Not Applicable

Detailed Description:

2 x 20 patients which are planned for arthroscopic ACL reconstruction are randomised: standard-group and LIA-group.

All patients receive standardised multimodal intravenous analgesia. After standardised induction of anesthesia, patient positioning and administration of basic analgetics (paracetamol, diclofenac, clonidine and morfine), patients in the LIA-group receive a local infiltration in the knee of 10 mL ropivacaine and 10 mL lidocaine.

Visual Analogue Scores are assessed 15 minutes after awakening from surgery and on Day 1, 2, 3, 7, 14, 21 and 28 after surgery. Postoperative analgesic consumption are registered in the first month after the surgery. The quality of recovery after anesthesia is assessed on Day 1 by the postoperative quality of recovery score (QoR-15).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Group A receives standard treatment (intravenous analgesia). Group B received intravenous analgesia and a LIA.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Local Infiltration Analgesia on Postoperative Pain Following Anterior Cruciate Ligament Reconstruction
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: intravenous analgesia
Patient receives intravenous analgesia: paracetamol 30 mg/kg, diclofenac 75 mg, clonidine 1 µg/kg and morfine 0,05 mg/kg
intravenous analgesia + LIA
Patient receives intravenous analgesia and a local infiltration analgesia in the knee
Procedure: local infiltration analgesia
10 mL ropivacaine 7.5 mg/mL and 10 mL lidocaine 10 mg/mL




Primary Outcome Measures :
  1. Visual Analogue Scale for pain [ Time Frame: From moment of surgery until one month after surgery ]
    Pain intensity using the VAS (where 0 = no pain and 100 = pain as bad as can be) 15 minutes after awakening and on Day 1, 2, 3, 7, 14, 21 and 28 after surgery.


Secondary Outcome Measures :
  1. Postoperative analgesia consumption [ Time Frame: From moment of surgery until one month after surgery ]
    Dosing and frequency of analgesia consumption

  2. General patient comfort [ Time Frame: From moment of surgery until one day after surgery ]
    Quality of recovery score (QoR-15) on the first day after surgery

  3. Incidence of nausea and vomiting [ Time Frame: From moment of surgery until hospital discharge (one day after surgery) ]
    Incidence of postoperative nausea and vomiting

  4. PONV treatment [ Time Frame: From moment of surgery until hospital discharge (one day after surgery) ]
    Number of pharmacological treatments for postoperative nausea and vomiting (PONV)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective arthroscopic anterior cruciate ligament reconstruction
  • adult

Exclusion Criteria:

  • unwilling or unable to grant written informed consent
  • revisions
  • contra-indication for ropivacaine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873077


Contacts
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Contact: Alain F Kalmar, MD, PhD, MSc +32 246 17 29 alainkalmar@gmail.com
Contact: Pieter Byn, MD, Msc pieterbyn@hotmail.com

Locations
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Belgium
General Hospital Maria Middelares Recruiting
Ghent, Oost-Vlaanderen, Belgium, 9000
Contact: Alain F Kalmar         
Sponsors and Collaborators
Algemeen Ziekenhuis Maria Middelares
Investigators
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Principal Investigator: Alain F Kalmar Maria Middelares Hospital

Publications:
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Responsible Party: Dr. Alain Kalmar, MD, PhD, Staff Anesthesist, Algemeen Ziekenhuis Maria Middelares
ClinicalTrials.gov Identifier: NCT03873077     History of Changes
Other Study ID Numbers: MMS.2019.001
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Alain Kalmar, MD, PhD, Algemeen Ziekenhuis Maria Middelares:
local infiltration analgesia
postoperative analgesia
Additional relevant MeSH terms:
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Pain, Postoperative
Rupture
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Wounds and Injuries