An interventional study of local infiltration analgesia in Anterior Cruciate Ligament Rupture and Pain, Postoperative, sponsored by Algemeen Ziekenhuis Maria Middelares. Status unknown at 1 site in Belgium. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-03-13.
Sponsored by Algemeen Ziekenhuis Maria Middelares · Not applicable, Interventional, and Supportive care
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).
521 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 169 are open to participants now.
This study's planned enrollment of 40 is below the median of 56 across 378 interventional studies indexed under Anterior Cruciate Ligament Injuries.
Browse Anterior Cruciate Ligament Injuries studies →Algemeen Ziekenhuis Maria Middelares is the lead sponsor of 37 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
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
Procedure: local infiltration analgesia
10 mL ropivacaine 7.5 mg/mL and 10 mL lidocaine 10 mg/mL
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.
Time frame: From moment of surgery until one month after surgery
Postoperative analgesia consumption
Dosing and frequency of analgesia consumption
Time frame: From moment of surgery until one month after surgery
General patient comfort
Quality of recovery score (QoR-15) on the first day after surgery
Time frame: From moment of surgery until one day after surgery
Incidence of nausea and vomiting
Incidence of postoperative nausea and vomiting
Time frame: From moment of surgery until hospital discharge (one day after surgery)
PONV treatment
Number of pharmacological treatments for postoperative nausea and vomiting (PONV)
Time frame: From moment of surgery until hospital discharge (one day after surgery)
Plan to share: No
This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Anterior Cruciate Ligament Injuries →
Algemeen Ziekenhuis Maria Middelares