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
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|
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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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|
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
- 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.
- Postoperative analgesia consumption [ Time Frame: From moment of surgery until one month after surgery ]Dosing and frequency of analgesia consumption
- 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
- Incidence of nausea and vomiting [ Time Frame: From moment of surgery until hospital discharge (one day after surgery) ]Incidence of postoperative nausea and vomiting
- 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)
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
|Contact: Alain F Kalmar, MD, PhD, MSc||+32 246 17 email@example.com|
|Contact: Pieter Byn, MD, Mscfirstname.lastname@example.org|
|General Hospital Maria Middelares||Recruiting|
|Ghent, Oost-Vlaanderen, Belgium, 9000|
|Contact: Alain F Kalmar|
|Principal Investigator:||Alain F Kalmar||Maria Middelares Hospital|