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Effect of LIA on Postoperative Pain Following ACL Reconstruction

Primary Purpose

Anterior Cruciate Ligament Rupture, Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
local infiltration analgesia
Sponsored by
Algemeen Ziekenhuis Maria Middelares
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anterior Cruciate Ligament Rupture focused on measuring local infiltration analgesia, postoperative analgesia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • elective arthroscopic anterior cruciate ligament reconstruction
  • adult

Exclusion Criteria:

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

Sites / Locations

  • General Hospital Maria MiddelaresRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

intravenous analgesia

intravenous analgesia + LIA

Arm Description

Patient receives intravenous analgesia: paracetamol 30 mg/kg, diclofenac 75 mg, clonidine 1 µg/kg and morfine 0,05 mg/kg

Patient receives intravenous analgesia and a local infiltration analgesia in the knee

Outcomes

Primary Outcome Measures

Visual Analogue Scale for pain
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

Postoperative analgesia consumption
Dosing and frequency of analgesia consumption
General patient comfort
Quality of recovery score (QoR-15) on the first day after surgery
Incidence of nausea and vomiting
Incidence of postoperative nausea and vomiting
PONV treatment
Number of pharmacological treatments for postoperative nausea and vomiting (PONV)

Full Information

First Posted
March 11, 2019
Last Updated
March 11, 2019
Sponsor
Algemeen Ziekenhuis Maria Middelares
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1. Study Identification

Unique Protocol Identification Number
NCT03873077
Brief Title
Effect of LIA on Postoperative Pain Following ACL Reconstruction
Official Title
Effect of Local Infiltration Analgesia on Postoperative Pain Following Anterior Cruciate Ligament Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Algemeen Ziekenhuis Maria Middelares

4. Oversight

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

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Rupture, Pain, Postoperative
Keywords
local infiltration analgesia, postoperative analgesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group A receives standard treatment (intravenous analgesia). Group B received intravenous analgesia and a LIA.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intravenous analgesia
Arm Type
No Intervention
Arm Description
Patient receives intravenous analgesia: paracetamol 30 mg/kg, diclofenac 75 mg, clonidine 1 µg/kg and morfine 0,05 mg/kg
Arm Title
intravenous analgesia + LIA
Arm Type
Other
Arm Description
Patient receives intravenous analgesia and a local infiltration analgesia in the knee
Intervention Type
Procedure
Intervention Name(s)
local infiltration analgesia
Intervention Description
10 mL ropivacaine 7.5 mg/mL and 10 mL lidocaine 10 mg/mL
Primary Outcome Measure Information:
Title
Visual Analogue Scale for pain
Description
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.
Time Frame
From moment of surgery until one month after surgery
Secondary Outcome Measure Information:
Title
Postoperative analgesia consumption
Description
Dosing and frequency of analgesia consumption
Time Frame
From moment of surgery until one month after surgery
Title
General patient comfort
Description
Quality of recovery score (QoR-15) on the first day after surgery
Time Frame
From moment of surgery until one day after surgery
Title
Incidence of nausea and vomiting
Description
Incidence of postoperative nausea and vomiting
Time Frame
From moment of surgery until hospital discharge (one day after surgery)
Title
PONV treatment
Description
Number of pharmacological treatments for postoperative nausea and vomiting (PONV)
Time Frame
From moment of surgery until hospital discharge (one day after surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alain F Kalmar, MD, PhD, MSc
Phone
+32 246 17 29
Email
alainkalmar@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pieter Byn, MD, Msc
Email
pieterbyn@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain F Kalmar
Organizational Affiliation
Maria Middelares Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital Maria Middelares
City
Ghent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain F Kalmar

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23411725
Citation
Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
Results Reference
background
PubMed Identifier
27720193
Citation
Lefevre N, Klouche S, de Pamphilis O, Herman S, Gerometta A, Bohu Y. Peri-articular local infiltration analgesia versus femoral nerve block for postoperative pain control following anterior cruciate ligament reconstruction: Prospective, comparative, non-inferiority study. Orthop Traumatol Surg Res. 2016 Nov;102(7):873-877. doi: 10.1016/j.otsr.2016.07.011. Epub 2016 Oct 4.
Results Reference
background
PubMed Identifier
18484242
Citation
Kerr DR, Kohan L. Local infiltration analgesia: a technique for the control of acute postoperative pain following knee and hip surgery: a case study of 325 patients. Acta Orthop. 2008 Apr;79(2):174-83. doi: 10.1080/17453670710014950.
Results Reference
background
PubMed Identifier
23338666
Citation
Kristensen PK, Pfeiffer-Jensen M, Storm JO, Thillemann TM. Local infiltration analgesia is comparable to femoral nerve block after anterior cruciate ligament reconstruction with hamstring tendon graft: a randomised controlled trial. Knee Surg Sports Traumatol Arthrosc. 2014 Feb;22(2):317-23. doi: 10.1007/s00167-013-2399-x. Epub 2013 Jan 23.
Results Reference
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Effect of LIA on Postoperative Pain Following ACL Reconstruction

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