Ignite Creation Date:
2024-05-06 @ 12:52 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03873077
Status:
UNKNOWN
Last Update Posted:
2019-03-13
First Post:
2019-03-11
Brief Title:
Effect of LIA on Postoperative Pain Following ACL Reconstruction
Sponsor:
Algemeen Ziekenhuis Maria Middelares
Organization:
Algemeen Ziekenhuis Maria Middelares
Study Overview
Official Title:
Effect of Local Infiltration Analgesia on Postoperative Pain Following Anterior Cruciate Ligament Reconstruction
Status:
UNKNOWN
Status Verified Date:
2019-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None