Effect of LIA on Postoperative Pain Following ACL Reconstruction

March 11, 2019 updated by: Dr. Alain Kalmar, MD, PhD, Algemeen Ziekenhuis Maria Middelares

Effect of Local Infiltration Analgesia on Postoperative Pain Following Anterior Cruciate Ligament Reconstruction

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • General Hospital Maria Middelares
        • Contact:
          • Alain F Kalmar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • elective arthroscopic anterior cruciate ligament reconstruction
  • adult

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From moment of surgery until one month after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative analgesia consumption
Time Frame: From moment of surgery until one month after surgery
Dosing and frequency of analgesia consumption
From moment of surgery until one month after surgery
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
From moment of surgery until one day after surgery
Incidence of nausea and vomiting
Time Frame: From moment of surgery until hospital discharge (one day after surgery)
Incidence of postoperative nausea and vomiting
From moment of surgery until hospital discharge (one day after surgery)
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)
From moment of surgery until hospital discharge (one day after surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Algemeen Ziekenhuis Maria Middelares

Investigators

  • Principal Investigator: Alain F Kalmar, Maria Middelares Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2019

Primary Completion (ANTICIPATED)

February 1, 2020

Study Completion (ANTICIPATED)

March 1, 2020

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 11, 2019

First Posted (ACTUAL)

March 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 11, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMS.2019.001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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