Postoperative Pain
Conditions
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.
Interventions
DRUGDexamethasone phosphate
At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation
DRUGParacetamol
After the block regression, at the first analgetic request the patients received the analgesia protocol
DRUGMorphine
After the block regression, at the first analgetic request the patients received the analgesia protocol
DRUGLidocaine
At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation
DRUGRopivacaine
At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation
Sponsors
Foisor Orthopedics Clinical Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the total amount of morphine | At 24 hour postoperative | the morphine administered in milligrams |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the patient satisfaction | At 24 hour postoperative | evaluation of satisfaction by a questionnaire |
| the number of patients with neurological motility side effects | At 24 h postoperative | Following the postoperative motility of operated lower limb by Bromage scale |
| duration of analgesia | the first 24 hours | the time interval from performing the block until the first analgesic dose required at VAS \>3 (0 - no pain, 10 - the worst pain possible |
| the number of patients with neurological sensibility side effects | At 21 days postoperative | Following postoperative sensibility of operated lower limb by pinprick test |
Countries
Romania
Outcome results
None listed