Perineural Dexamethasone in Femural Nerve Block After Ligament Reconstruction

August 1, 2017 updated by: Munteanu Ana Maria, MD, PhD, Foisor Orthopedics Clinical Hospital

Perineural Dexamethasone Administered in Femural Nerve Block After Anterior Cruciate 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucharest, Romania, 021382
        • Foisor Orthopedics Clinical Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • Perfalgan
Drug: Morphine
After the block regression, at the first analgetic request the patients received the analgesia protocol
Other Names:
  • 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 Names:
  • Xylocaine
Drug: Ropivacaine
At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Names:
  • 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: Paracetamol
After the block regression, at the first analgetic request the patients received the analgesia protocol
Other Names:
  • Perfalgan
Drug: Morphine
After the block regression, at the first analgetic request the patients received the analgesia protocol
Other Names:
  • 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 Names:
  • Xylocaine
Drug: Ropivacaine
At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Names:
  • Naropin
Drug: Dexamethasone phosphate
At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Names:
  • Decadron
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: Paracetamol
After the block regression, at the first analgetic request the patients received the analgesia protocol
Other Names:
  • Perfalgan
Drug: Morphine
After the block regression, at the first analgetic request the patients received the analgesia protocol
Other Names:
  • 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 Names:
  • Xylocaine
Drug: Ropivacaine
At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Names:
  • Naropin
Drug: Dexamethasone phosphate
At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Names:
  • Decadron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the total amount of morphine
Time Frame: At 24 hour postoperative
the morphine administered in milligrams
At 24 hour postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the patient satisfaction
Time Frame: At 24 hour postoperative
evaluation of satisfaction by a questionnaire
At 24 hour postoperative
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
At 24 h postoperative
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
the first 24 hours
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
At 21 days postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foisor Orthopedics Clinical Hospital

Investigators

  • Study Director: Ioan Cristian Stoica, Prof, Foisor Orthopedics Clinical Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

February 22, 2016

First Submitted That Met QC Criteria

April 21, 2016

First Posted (Estimate)

April 22, 2016

Study Record Updates

Last Update Posted (Actual)

August 2, 2017

Last Update Submitted That Met QC Criteria

August 1, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID AN-001-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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