Perineural Dexamethasone in Femural Nerve Block After Ligament Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-02-28

Brief Summary

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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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Detailed Description

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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

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A

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.

Group Type PLACEBO_COMPARATOR

Paracetamol

Intervention Type DRUG

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

Morphine

Intervention Type DRUG

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

Lidocaine

Intervention Type DRUG

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

Ropivacaine

Intervention Type DRUG

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

Group B

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.

Group Type ACTIVE_COMPARATOR

Dexamethasone phosphate

Intervention Type DRUG

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

Paracetamol

Intervention Type DRUG

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

Morphine

Intervention Type DRUG

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

Lidocaine

Intervention Type DRUG

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

Ropivacaine

Intervention Type DRUG

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

Group C

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.

Group Type ACTIVE_COMPARATOR

Dexamethasone phosphate

Intervention Type DRUG

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

Paracetamol

Intervention Type DRUG

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

Morphine

Intervention Type DRUG

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

Lidocaine

Intervention Type DRUG

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

Ropivacaine

Intervention Type DRUG

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

Interventions

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Dexamethasone phosphate

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

Intervention Type DRUG

Paracetamol

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

Intervention Type DRUG

Morphine

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

Intervention Type DRUG

Lidocaine

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

Intervention Type DRUG

Ropivacaine

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

Intervention Type DRUG

Other Intervention Names

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Decadron Perfalgan Morphine Sulfate Xylocaine Naropin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No