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Perineural Dexamethasone in Femural Nerve Block After Ligament Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02749162
Recruitment Status : Completed
First Posted : April 22, 2016
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
Munteanu Ana Maria, MD, PhD, Foisor Orthopedics Clinical Hospital

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Dexamethasone phosphate Drug: Paracetamol Drug: Morphine Drug: Lidocaine Drug: Ropivacaine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Perineural Dexamethasone Administered in Femural Nerve Block After Anterior Cruciate Ligament Reconstruction
Study Start Date : November 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017


Arm Intervention/treatment
Placebo Comparator: 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.
Drug: Paracetamol
After the block regression, at the first analgetic request the patients received the analgesia protocol
Other Name: Perfalgan

Drug: Morphine
After the block regression, at the first analgetic request the patients received the analgesia protocol
Other Name: Morphine Sulfate

Drug: Lidocaine
At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Name: Xylocaine

Drug: Ropivacaine
At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Name: Naropin

Active Comparator: 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.
Drug: Dexamethasone phosphate
At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Name: Decadron

Drug: Paracetamol
After the block regression, at the first analgetic request the patients received the analgesia protocol
Other Name: Perfalgan

Drug: Morphine
After the block regression, at the first analgetic request the patients received the analgesia protocol
Other Name: Morphine Sulfate

Drug: Lidocaine
At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Name: Xylocaine

Drug: Ropivacaine
At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Name: Naropin

Active Comparator: 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.
Drug: Dexamethasone phosphate
At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Name: Decadron

Drug: Paracetamol
After the block regression, at the first analgetic request the patients received the analgesia protocol
Other Name: Perfalgan

Drug: Morphine
After the block regression, at the first analgetic request the patients received the analgesia protocol
Other Name: Morphine Sulfate

Drug: Lidocaine
At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Name: Xylocaine

Drug: Ropivacaine
At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Name: Naropin




Primary Outcome Measures :
  1. the total amount of morphine [ Time Frame: At 24 hour postoperative ]
    the morphine administered in milligrams


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02749162


Locations
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Romania
Foisor Orthopedics Clinical Hospital
Bucharest, Romania, 021382
Sponsors and Collaborators
Foisor Orthopedics Clinical Hospital
Investigators
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Study Director: Ioan Cristian Stoica, Prof Foisor Orthopedics Clinical Hospital

Publications of Results:
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Responsible Party: Munteanu Ana Maria, MD, PhD, MD PhD, Foisor Orthopedics Clinical Hospital
ClinicalTrials.gov Identifier: NCT02749162    
Other Study ID Numbers: ID AN-001-14
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Dexamethasone
Dexamethasone acetate
Lidocaine
Morphine
Ropivacaine
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics