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Completed

NCT Number: NCT02749162

Perineural Dexamethasone in Femural Nerve Block After Ligament Reconstruction

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Foisor Orthopedics Clinical Hospital

Bucharest, 021382, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone phosphate

Drug

At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation

Other names: Decadron

Paracetamol

Drug

After the block regression, at the first analgetic request the patients received the analgesia protocol

Other names: Perfalgan

Morphine

Drug

After the block regression, at the first analgetic request the patients received the analgesia protocol

Other names: Morphine Sulfate

Lidocaine

Drug

At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation

Other names: Xylocaine

Ropivacaine

Drug

At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation

Other names: Naropin

Primary outcomes

  1. the total amount of morphine

    Time frame: At 24 hour postoperative

    the morphine administered in milligrams

Secondary outcomes

  1. the patient satisfaction

    Time frame: At 24 hour postoperative

    evaluation of satisfaction by a questionnaire

  2. the number of patients with neurological motility side effects

    Time frame: At 24 h postoperative

    Following the postoperative motility of operated lower limb by Bromage scale

  3. duration of analgesia

    Time frame: 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

  4. the number of patients with neurological sensibility side effects

    Time frame: At 21 days postoperative

    Following postoperative sensibility of operated lower limb by pinprick test

Sponsors and collaborators

Lead sponsor

Foisor Orthopedics Clinical Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 22, 2016
Registry last updated
Aug 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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