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Perineural Dexamethasone in Femural Nerve Block After Ligament Reconstruction

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 3
Locations
Romania
Study Type
Interventional
Intervention
Dexamethasone phosphate
Paracetamol
Morphine
Lidocaine
Ropivacaine
Sponsored by
Foisor Orthopedics Clinical Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Foisor Orthopedics Clinical Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Group C

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

the total amount of morphine
the morphine administered in milligrams

Secondary Outcome Measures

the patient satisfaction
evaluation of satisfaction by a questionnaire
the number of patients with neurological motility side effects
Following the postoperative motility of operated lower limb by Bromage scale
duration of analgesia
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 number of patients with neurological sensibility side effects
Following postoperative sensibility of operated lower limb by pinprick test

Full Information

First Posted
February 22, 2016
Last Updated
August 1, 2017
Sponsor
Foisor Orthopedics Clinical Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02749162
Brief Title
Perineural Dexamethasone in Femural Nerve Block After Ligament Reconstruction
Official Title
Perineural Dexamethasone Administered in Femural Nerve Block After Anterior Cruciate Ligament Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Foisor Orthopedics Clinical Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Group B
Arm Type
Active Comparator
Arm 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.
Arm Title
Group C
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone phosphate
Other Intervention Name(s)
Decadron
Intervention Description
At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Other Intervention Name(s)
Perfalgan
Intervention Description
After the block regression, at the first analgetic request the patients received the analgesia protocol
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
Morphine Sulfate
Intervention Description
After the block regression, at the first analgetic request the patients received the analgesia protocol
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
Xylocaine
Intervention Description
At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation
Primary Outcome Measure Information:
Title
the total amount of morphine
Description
the morphine administered in milligrams
Time Frame
At 24 hour postoperative
Secondary Outcome Measure Information:
Title
the patient satisfaction
Description
evaluation of satisfaction by a questionnaire
Time Frame
At 24 hour postoperative
Title
the number of patients with neurological motility side effects
Description
Following the postoperative motility of operated lower limb by Bromage scale
Time Frame
At 24 h postoperative
Title
duration of analgesia
Description
the time interval from performing the block until the first analgesic dose required at VAS >3 (0 - no pain, 10 - the worst pain possible
Time Frame
the first 24 hours
Title
the number of patients with neurological sensibility side effects
Description
Following postoperative sensibility of operated lower limb by pinprick test
Time Frame
At 21 days postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ioan Cristian Stoica, Prof
Organizational Affiliation
Foisor Orthopedics Clinical Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Foisor Orthopedics Clinical Hospital
City
Bucharest
ZIP/Postal Code
021382
Country
Romania

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25774458
Citation
Huynh TM, Marret E, Bonnet F. Combination of dexamethasone and local anaesthetic solution in peripheral nerve blocks: A meta-analysis of randomised controlled trials. Eur J Anaesthesiol. 2015 Nov;32(11):751-8. doi: 10.1097/EJA.0000000000000248.
Results Reference
result
PubMed Identifier
21519308
Citation
Williams BA, Hough KA, Tsui BY, Ibinson JW, Gold MS, Gebhart GF. Neurotoxicity of adjuvants used in perineural anesthesia and analgesia in comparison with ropivacaine. Reg Anesth Pain Med. 2011 May-Jun;36(3):225-30. doi: 10.1097/AAP.0b013e3182176f70.
Results Reference
result
PubMed Identifier
25485150
Citation
De Oliveira GS Jr, Castro Alves LJ, Nader A, Kendall MC, Rahangdale R, McCarthy RJ. Perineural dexamethasone to improve postoperative analgesia with peripheral nerve blocks: a meta-analysis of randomized controlled trials. Pain Res Treat. 2014;2014:179029. doi: 10.1155/2014/179029. Epub 2014 Nov 18.
Results Reference
result
PubMed Identifier
21956081
Citation
Brummett CM, Williams BA. Additives to local anesthetics for peripheral nerve blockade. Int Anesthesiol Clin. 2011 Fall;49(4):104-16. doi: 10.1097/AIA.0b013e31820e4a49.
Results Reference
result
PubMed Identifier
24781562
Citation
Williams BA, Schott NJ, Mangione MP, Ibinson JW. Perineural dexamethasone and multimodal perineural analgesia: how much is too much? Anesth Analg. 2014 May;118(5):912-4. doi: 10.1213/ANE.0000000000000203. No abstract available.
Results Reference
result

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Perineural Dexamethasone in Femural Nerve Block After Ligament Reconstruction

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