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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| local infiltration analgesia | Procedure | 10 mL ropivacaine 7.5 mg/mL and 10 mL lidocaine 10 mg/mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From moment of surgery until one month after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative analgesia consumption | Dosing and frequency of analgesia consumption | From moment of surgery until one month after surgery |
| General patient comfort | Quality of recovery score (QoR-15) on the first day after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alain F Kalmar, MD, PhD, MSc | Contact | +32 246 17 29 | alainkalmar@gmail.com | |
| Pieter Byn, MD, Msc | Contact | pieterbyn@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Alain F Kalmar | Maria Middelares Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital Maria Middelares | Recruiting | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23411725 | Background | 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. | |
| 27720193 | Background | 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. |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D011183 | Postoperative Complications |
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Group A receives standard treatment (intravenous analgesia). Group B received intravenous analgesia and a LIA.
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| From moment of surgery until one day after surgery |
| Incidence of nausea and vomiting | Incidence of postoperative nausea and vomiting | From moment of surgery until hospital discharge (one day after surgery) |
| PONV treatment | Number of pharmacological treatments for postoperative nausea and vomiting (PONV) | From moment of surgery until hospital discharge (one day after surgery) |
| 18484242 | Background | 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. |
| 23338666 | Background | 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. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |