NCT02749162

Perineural Dexamethasone in Femural Nerve Block After Ligament Reconstruction

Perineural Dexamethasone Administered in Femural Nerve Block After Anterior Cruciate Ligament Reconstruction

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Foisor Orthopedics Clinical Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The effect of perineural dexamethasone administered as an adjuvant in prolonging the duration of analgesia continues to be under debate. The investigators performed a prospective randomized study to evaluate the effect of perineural dexamethasone in different concentrations in postoperative analgesia in femoral nerve block for anterior cruciate ligament reconstruction.

Detailed description

After Ethics committee approval, 75 patients American Society of Anesthesiologists score (ASA) I-III were randomized at the end of surgery into 3 groups of 25 patients each who underwent femoral nerve block: group A with 20 ml ropivacaine 0,5% and 20 ml lidocaine 1%; group B with 20 ml ropivacaine 0,5%, 20 ml lidocaine 1% and 4 mg dexamethasone; group C with 20 ml ropivacaine 0,5%, 20 ml lidocaine 1% and 8 mg dexamethasone. All groups received postoperative analgesia when visual analog scale (VAS) over 3 (by request), with IV Perfalgan 1 g and morphine (loading dose 0.1 mg/kg and titration until VAS under 3, followed by subcutaneous (SC) administration of 1/2 of total loading dose on demand for the following 24 hours (h) . Efficacy was evaluated by the time interval from performing the block until the first analgesic dose required, the total amount of morphine in the first 24 h postoperative, the patient satisfaction and the neurological side effects.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Dexamethasone phosphate	At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation
DRUG	Paracetamol	After the block regression, at the first analgetic request the patients received the analgesia protocol
DRUG	Morphine	After the block regression, at the first analgetic request the patients received the analgesia protocol
DRUG	Lidocaine	At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation
DRUG	Ropivacaine	At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2016-04-22
• Last updated: 2017-08-02

Locations

1 site across 1 country: Romania