Anterior Cruciate Ligament Rupture, Pain, Postoperative
Conditions
Keywords
local infiltration analgesia, postoperative analgesia
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).
Interventions
PROCEDURElocal infiltration analgesia
10 mL ropivacaine 7.5 mg/mL and 10 mL lidocaine 10 mg/mL
Sponsors
Algemeen Ziekenhuis Maria Middelares
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Group A receives standard treatment (intravenous analgesia). Group B received intravenous analgesia and a LIA.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* elective arthroscopic anterior cruciate ligament reconstruction * adult
Exclusion criteria
* unwilling or unable to grant written informed consent * revisions * contra-indication for ropivacaine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale for pain | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative analgesia consumption | From moment of surgery until one month after surgery | Dosing and frequency of analgesia consumption |
| General patient comfort | 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 | From moment of surgery until hospital discharge (one day after surgery) | Incidence of postoperative nausea and vomiting |
| PONV treatment | From moment of surgery until hospital discharge (one day after surgery) | Number of pharmacological treatments for postoperative nausea and vomiting (PONV) |
Countries
Belgium
Contacts
Primary ContactAlain F Kalmar, MD, PhD, MSc
Backup ContactPieter Byn, MD, Msc
Outcome results
None listed