Effect of LIA on Postoperative Pain Following ACL Reconstruction

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Спонзори

Algemeen Ziekenhuis Maria Middelares

КЛИНИЧКО ИСПИТУВАЊЕ: NCT03873077

BioSeek: NCT03873077

Клучни зборови

Апстракт

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.

Опис

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).

Датуми

Последен пат проверено:	02/28/2019
Прво доставено:	03/10/2019
Поднесено е проценето запишување:	03/10/2019
Прво објавено:	03/12/2019
Последното ажурирање е доставено:	03/10/2019
Последно ажурирање објавено:	03/12/2019
Крај на датумот на започнување на студијата:	02/28/2019
Проценет датум на примарно завршување:	01/31/2020
Проценет датум на завршување на студијата:	02/29/2020

Состојба или болест

Anterior Cruciate Ligament Rupture

Pain, Postoperative

Интервенција / третман

Procedure: intravenous analgesia + LIA

Фаза

Групи за раце

Рака	Интервенција / третман
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
Other: intravenous analgesia + LIA Patient receives intravenous analgesia and a local infiltration analgesia in the knee	Procedure: intravenous analgesia + LIA 10 mL ropivacaine 7.5 mg/mL and 10 mL lidocaine 10 mg/mL

Критериуми за подобност

Возраст подобни за студии	18 Years До 18 Years
Полови квалификувани за студии	All
Прифаќа здрави волонтери	Да
Критериуми	Inclusion Criteria: - elective arthroscopic anterior cruciate ligament reconstruction - adult Exclusion Criteria: - unwilling or unable to grant written informed consent - revisions - contra-indication for ropivacaine

Исход

Мерки на примарниот исход

1. 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.

Секундарни мерки на исходот

1. Postoperative analgesia consumption [From moment of surgery until one month after surgery]

Dosing and frequency of analgesia consumption

2. General patient comfort [From moment of surgery until one day after surgery]

Quality of recovery score (QoR-15) on the first day after surgery

3. Incidence of nausea and vomiting [From moment of surgery until hospital discharge (one day after surgery)]

Incidence of postoperative nausea and vomiting

4. PONV treatment [From moment of surgery until hospital discharge (one day after surgery)]

Number of pharmacological treatments for postoperative nausea and vomiting (PONV)

Effect of LIA on Postoperative Pain Following ACL Reconstruction

Клучни зборови

лидокаин

мачнина

повраќање

asthenia

rupture

muscle weakness

аналгетик