Perineural Dexamethasone in Femural Nerve Block After Ligament Reconstruction

F

Foisor Orthopedics Clinical Hospital

Status and phase

Completed
Phase 3

Conditions

Postoperative Pain

Treatments

Drug: Morphine
Drug: Dexamethasone phosphate
Drug: Ropivacaine
Drug: Paracetamol
Drug: Lidocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02749162
ID AN-001-14

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

90 participants in 3 patient groups, including a placebo group

Group A
Placebo Comparator group
Description:
After the spinal anesthesia regressed, the investigators performed a single shot femoral block with ropivacaine 0,5% 200 mg + lidocaine 1% 200 mg. After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.1 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS <3. After 2 h morphine was administered SC ½ of the total loading dose at request.
Treatment:
Drug: Lidocaine
Drug: Paracetamol
Drug: Ropivacaine
Drug: Morphine
Group B
Active Comparator group
Description:
After the spinal anesthesia regressed, the investigators performed a single shot femural block with ropivacaine 0,5% 200 mg + lidocaine 1% 200 mg and 4 mg dexamethasone phosphate. After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.1 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS <3. After 2 h morphine was administered SC ½ of the total loading dose at request.
Treatment:
Drug: Lidocaine
Drug: Paracetamol
Drug: Ropivacaine
Drug: Dexamethasone phosphate
Drug: Morphine
Group C
Active Comparator group
Description:
After the spinal anesthesia regressed, the investigators performed a single shot femural block with ropivacaine 0,5% 200 mg+ lidocaine 1% 200 mg and 8 mg dexamethasone phosphate.After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.1 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS <3. After 2 h morphine was administered SC ½ of the total loading dose at request.
Treatment:
Drug: Lidocaine
Drug: Paracetamol
Drug: Ropivacaine
Drug: Dexamethasone phosphate
Drug: Morphine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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