Clinical trial NCT02749162: Perineural Dexamethasone in Femural Nerve Block After Ligament Reconstruction
Official title: Perineural Dexamethasone Administered in Femural Nerve Block After Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Lead sponsor: Foisor Orthopedics Clinical Hospital
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* ASA I-III
* BMI\<40

Exclusion Criteria:

* High risk grade hypertension
* Chronic renal failure
* Known allergy to drugs used
* Chronic treatment with steroids
* Drugs dependency
* History of diabetes mellitus
* Ulcer or chronic gastritis
* Infection on the puncture site
* Neuropathy at the surgical level
* Coagulopathy
* Requesting another type of anesthesia
* Fear to sign informed consent
* By-pass aorto-femoral

Primary outcomes:
measure: the total amount of morphine
timeFrame: At 24 hour postoperative
Secondary outcomes:
measure: the patient satisfaction
timeFrame: At 24 hour postoperative
measure: the number of patients with neurological motility side effects
timeFrame: At 24 h postoperative
measure: duration of analgesia
timeFrame: the first 24 hours
measure: the number of patients with neurological sensibility side effects
timeFrame: At 21 days postoperative
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Foisor Orthopedics Clinical Hospital
Study officials:
affiliation: Foisor Orthopedics Clinical Hospital
name: Ioan Cristian Stoica, Prof
role: STUDY_DIRECTOR
References:
citation: Huynh TM, Marret E, Bonnet F. Combination of dexamethasone and local anaesthetic solution in peripheral nerve blocks: A meta-analysis of randomised controlled trials. Eur J Anaesthesiol. 2015 Nov;32(11):751-8. doi: 10.1097/EJA.0000000000000248.
citation: Williams BA, Hough KA, Tsui BY, Ibinson JW, Gold MS, Gebhart GF. Neurotoxicity of adjuvants used in perineural anesthesia and analgesia in comparison with ropivacaine. Reg Anesth Pain Med. 2011 May-Jun;36(3):225-30. doi: 10.1097/AAP.0b013e3182176f70.
citation: De Oliveira GS Jr, Castro Alves LJ, Nader A, Kendall MC, Rahangdale R, McCarthy RJ. Perineural dexamethasone to improve postoperative analgesia with peripheral nerve blocks: a meta-analysis of randomized controlled trials. Pain Res Treat. 2014;2014:179029. doi: 10.1155/2014/179029. Epub 2014 Nov 18.
citation: Brummett CM, Williams BA. Additives to local anesthetics for peripheral nerve blockade. Int Anesthesiol Clin. 2011 Fall;49(4):104-16. doi: 10.1097/AIA.0b013e31820e4a49.
citation: Williams BA, Schott NJ, Mangione MP, Ibinson JW. Perineural dexamethasone and multimodal perineural analgesia: how much is too much? Anesth Analg. 2014 May;118(5):912-4. doi: 10.1213/ANE.0000000000000203. No abstract available.