Perineural Low-dose Dexamethasone Added to Infraclavicular Block Anesthesia

NCT02698995 | Completed Phase 3 DMC

• 1 other identifier: ID AN-002-14
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Dexamethasone has an evidence-based indication in postoperative emesis prophylaxy and as a antiinflammatory steroid. Although the perineural administration is off-label, several studies recognised its analgetic action as an adjuvant for peripheral nerves blockade, permitting to reduce the concentration of the local anesthetics and extending the sensory and motor block.Questions remain concerning the mechanism of action, optimal dose, the lack/degree of toxicity and the comparison with intravenous administration.The aim of this prospective randomized controlled study is to investigate the efficacy of analgesia with 4 mg or 2 mg Dexamethasone added to a combination of ropivacaine 0,5% and lidocaine 1% in vertical infraclavicular blockade (VIB) anesthesia for upper limb surgery.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Sensory block duration

  The time in minutes measured between VIB block to first analgetic request

  First 24 hours

Secondary Outcomes (6)

• Motor block duration

  First 24 hours postoperatively

• Glycemic variations at 4 hours post-VIB block

  First 4 hours postoperatively

• Number of patients opioid free analgesia

  First 24 hours postoperatively

• VAS at the block regression

  First 24 hours postoperatively

• Cutaneous temperature ice-probe

  First 24 hours postoperatively

Study Arms (3)

Group A

PLACEBO COMPARATOR

VIB block with ropivacaine 0,5%100 mg+lidocaine1%100 mg+1 ml saline=21 ml. 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 0.05 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: Ropivacaine; Drug: Paracetamol; Drug: Morphine; Drug: Lidocaine

Group B

ACTIVE COMPARATOR

VIB block with ropivacaine 0,5%100 mg+lidocaine1%100 mg+2 mg dexamethasone=21 ml. 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 0.05 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; Drug: Ropivacaine; Drug: Paracetamol; Drug: Morphine; Drug: Lidocaine

Group C

ACTIVE COMPARATOR

VIB block with ropivacaine 0,5%100 mg+lidocaine1%100 mg+4 mg dexamethasone=21 ml. 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 0.05 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; Drug: Ropivacaine; Drug: Paracetamol; Drug: Morphine; Drug: Lidocaine

Interventions

Dexamethasone DRUG

One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation

Also known as: Decadron

Group B; Group C

Ropivacaine DRUG

One hour before 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

Paracetamol DRUG

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

Also known as: Morphine Sulfate ER

Group A; Group B; Group C

Lidocaine DRUG

One hour before 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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-III,
• BMI\<40,
• non-anemic

You may not qualify if:

• High risk grade hypertension, chronic renal failure, known allergy to local anesthetic or NSAIDs, chronic treatment with steroids, drugs dependency, history of diabetes mellitus, ulcer or chronic gastritis, infection on the puncture site, chronic obstructive pulmonary disease, neuropathy at the surgical level

Sponsors & Collaborators

• Foisor Orthopedics Clinical Hospital: lead

Study Sites (1)

Foisor Orthopedic Clinical Hospital

Bucharest, 021383, Romania

Location

Related Publications (6)

• Kalichman MW, Powell HC, Myers RR. Pathology of local anesthetic-induced nerve injury. Acta Neuropathol. 1988;75(6):583-9. doi: 10.1007/BF00686203.

  PMID: 3376761 RESULT

• Myers RR, Kalichman MW, Reisner LS, Powell HC. Neurotoxicity of local anesthetics: altered perineurial permeability, edema, and nerve fiber injury. Anesthesiology. 1986 Jan;64(1):29-35.

  PMID: 3942334 RESULT

• Zink W, Graf BM. The toxicity of local anesthetics: the place of ropivacaine and levobupivacaine. Curr Opin Anaesthesiol. 2008 Oct;21(5):645-50. doi: 10.1097/ACO.0b013e32830c214c.

  PMID: 18784493 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

• 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

• Kawanishi R, Yamamoto K, Tobetto Y, Nomura K, Kato M, Go R, Tsutsumi YM, Tanaka K, Takeda Y. Perineural but not systemic low-dose dexamethasone prolongs the duration of interscalene block with ropivacaine: a prospective randomized trial. Local Reg Anesth. 2014 Apr 5;7:5-9. doi: 10.2147/LRA.S59158. eCollection 2014.

  PMID: 24817819 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone; Calcium Dobesilate; Ropivacaine; Acetaminophen; Morphine; Lidocaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; 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

Study Officials

• Ioan Cristian Stoica, MD 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 19, 2016
• First Posted: March 4, 2016
• Study Start: November 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: August 20, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)