Perineural Dexamethasone in Femural Nerve Block After Ligament Reconstruction

NCT02749162 | Completed Phase 3 DMC

• 1 other identifier: ID AN-001-14
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• the total amount of morphine

  the morphine administered in milligrams

  At 24 hour postoperative

Secondary Outcomes (4)

• the patient satisfaction

  At 24 hour postoperative

• the number of patients with neurological motility side effects

  At 24 h postoperative

• duration of analgesia

  the first 24 hours

• the number of patients with neurological sensibility side effects

  At 21 days postoperative

Study Arms (3)

Group A

PLACEBO COMPARATOR

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; Drug: Morphine; Drug: Lidocaine; Drug: Ropivacaine

Group B

ACTIVE COMPARATOR

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; Drug: Paracetamol; Drug: Morphine; Drug: Lidocaine; Drug: Ropivacaine

Group C

ACTIVE COMPARATOR

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; Drug: Paracetamol; Drug: Morphine; Drug: Lidocaine; Drug: Ropivacaine

Interventions

Dexamethasone phosphate DRUG

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

Also known as: Decadron

Group B; Group C

Paracetamol DRUG

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

Also known as: Perfalgan

Group A; Group B; Group C

Morphine DRUG

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

Also known as: Morphine Sulfate

Group A; Group B; Group C

Lidocaine DRUG

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

Also known as: Xylocaine

Group A; Group B; Group C

Ropivacaine DRUG

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

Also known as: Naropin

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I-III
• BMI\<40

You may not qualify if:

• 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

Sponsors & Collaborators

• Foisor Orthopedics Clinical Hospital: lead

Study Sites (1)

Foisor Orthopedics Clinical Hospital

Bucharest, 021382, Romania

Location

Related Publications (5)

• 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.

  PMID: 25774458 RESULT

• 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.

  PMID: 21519308 RESULT

• 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.

  PMID: 25485150 RESULT

• 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.

  PMID: 21956081 RESULT

• 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.

  PMID: 24781562 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

dexamethasone 21-phosphate; Calcium Dobesilate; Acetaminophen; Morphine; Lidocaine; Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Ioan Cristian Stoica, Prof

  Foisor Orthopedics Clinical Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: April 22, 2016
• Study Start: November 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: August 2, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)