Anterior Cruciate Ligament RuptureNCT03873077
Effect of LIA on Postoperative Pain Following ACL Reconstruction
A study testing local infiltration analgesia in people with Anterior Cruciate Ligament Rupture and Pain, Postoperative, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture, Pain, Postoperative
- What is being tested?
- local infiltration analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2019to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective arthroscopic anterior cruciate ligament reconstruction
- adult
Who cannot join
- unwilling or unable to grant written informed consent
- revisions
- contra-indication for ropivacaine
Trial locations and contacts
1 site in 1 country.
Pieter Byn, MD, Msc contact
Belgium1 site, 1 recruiting
- Recruiting
General Hospital Maria Middelares
Ghent, Oost-Vlaanderen, 9000
Alain F Kalmar
About this study
Official title: 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.
Read the 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).
- Being tested
- local infiltration analgesia
- Keywords
- local infiltration analgesia, postoperative analgesia
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local infiltration analgesiaProcedure or surgery
10 mL ropivacaine 7.5 mg/mL and 10 mL lidocaine 10 mg/mL
| Study group | Role | What they receive |
|---|---|---|
| intravenous analgesia | No intervention | Patient receives intravenous analgesia: paracetamol 30 mg/kg, diclofenac 75 mg, clonidine 1 µg/kg and morfine 0,05 mg/kg |
| intravenous analgesia + LIA | Other | Patient receives intravenous analgesia and a local infiltration analgesia in the knee Receives: Procedure: local infiltration analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From moment of surgery until one month after surgery
Secondary outcomes (4)
Postoperative analgesia consumption
Dosing and frequency of analgesia consumption
Measured: From moment of surgery until one month after surgery
General patient comfort
Quality of recovery score (QoR-15) on the first day after surgery
Measured: From moment of surgery until one day after surgery
Incidence of nausea and vomiting
Incidence of postoperative nausea and vomiting
Measured: From moment of surgery until hospital discharge (one day after surgery)
PONV treatment
Number of pharmacological treatments for postoperative nausea and vomiting (PONV)
Measured: From moment of surgery until hospital discharge (one day after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start1 Mar 2019
- Primary completionFeb 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A receives standard treatment (intravenous analgesia). Group B received intravenous analgesia and a LIA.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Algemeen Ziekenhuis Maria Middelares
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Alain Kalmar, MD, PhD, Algemeen Ziekenhuis Maria Middelares
- Investigators
- Alain F Kalmar, Principal investigator, Maria Middelares Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873077
- Sponsor's protocol ID
- MMS.2019.001
- Status last verified
- Mar 2019
- First submitted
- 11 Mar 2019
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23411725Lefevre 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.
PubMed 27720193Kerr 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.
PubMed 18484242Kristensen 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.
PubMed 23338666
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Local Infiltration Analgesia on Postoperative Pain Following Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT03873077
- Acronym / sponsor ID
- MMS.2019.001
- Keywords
- local infiltration analgesia, postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Algemeen Ziekenhuis Maria MiddelaresUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Group A receives standard treatment (intravenous analgesia). Group B received intravenous analgesia and a LIA.
| Arm | Type | Receives |
|---|---|---|
| intravenous analgesia | No intervention | –Patient receives intravenous analgesia: paracetamol 30 mg/kg, diclofenac 75 mg, clonidine 1 µg/kg and morfine 0,05 mg/kg |
| intravenous analgesia + LIA | Other | Procedure: local infiltration analgesiaPatient receives intravenous analgesia and a local infiltration analgesia in the knee |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- elective arthroscopic anterior cruciate ligament reconstruction
- adult
Key exclusion criteria (3 listed)
- unwilling or unable to grant written informed consent
- revisions
- contra-indication for ropivacaine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| local infiltration analgesia10 mL ropivacaine 7.5 mg/mL and 10 mL lidocaine 10 mg/mL | Procedure or surgery | intravenous analgesia + LIA |
Primary outcome
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.
4 secondary outcomes
Postoperative analgesia consumption
Time frame: From moment of surgery until one month after surgery
General patient comfort
Time frame: 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)
PONV treatment
Time frame: From moment of surgery until hospital discharge (one day after surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Background: PubMed 23411725Stark 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.
- Background: PubMed 27720193Lefevre 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.
- Background: PubMed 18484242Kerr 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.
- Background: PubMed 23338666Kristensen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pieter Byn, MD, Msc contact
Alain F Kalmar principal investigator
Maria Middelares Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing local infiltration analgesia in people with Anterior Cruciate Ligament Rupture and Pain, Postoperative, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alain F Kalmar, MD, PhD, MSc (+32 246 17 29, alainkalmar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale for pain (time frame: From moment of surgery until one month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03873077, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.