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Intravenous Versus Perineural Effect Dexamethasone in Interscalene Nerve Block With Levobupivacaine

M

Mansoura University

Status

Unknown

Conditions

Shoulder Pain

Treatments

Drug: Intravenous dexamethasone with perineural levobupivacaine
Drug: Perineural dexamethasone in addition to levobupivacaine
Drug: Perineural levobupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT04284007
MFM_IRB, MS.18.03.65 -

Details and patient eligibility

About

Interscalene brachial plexus block can be used as an additive to general anaesthesia or as the primary anaesthetic for shoulder surgeries for pain management.

The investigators compared the effect of perineural versus intravenous dexamethasone on the prolongation of the action of levobupivacaine in ultrasound guided interscalene block for shoulder and upper arm surgeries.

Full description

Dexamethasone had been shown to prolong the duration of postoperative analgesia when given as an adjuvant for peripheral nerve blocks.

The investigators compared the effect of perineural versus intravenous dexamethasone on the prolongation of the action of levobupivacaine in ultrasound guided interscalene block for shoulder and upper arm surgeries.

The study hypothesized that adding perineural dexamethasone to levobupivacaine in ultrasound guided interscalene block may be more superior to adding intravenous dexamethasone to levobupivacaine and levobupivacaine alone in shoulder and upper arm surgeries as regard analgesic effect, duration of analgesia and hemodynamic stability.

Enrollment

90 estimated patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • American Society of Anesthesiologists physical status grade I and grade II.

Exclusion criteria

  • Patient refusal.
  • Neuromuscular diseases (as myopathies, myasthenia gravies, ......)
  • Hematological diseases, bleeding or coagulation abnormality.
  • Psychiatric diseases.
  • Local skin infection
  • Sepsis at site of the block.
  • Known intolerance to the study drugs.
  • Body Mass Index > 40 Kg/m2
  • contralateral phrenic palsy
  • pneumothorax
  • pneumectomy
  • severe COPD

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 3 patient groups

Perineural levobupivacaine with intravenous saline
Active Comparator group
Description:
Patients will receive levobupivacaine plus saline in interscalene brachial plexus block in addition to intravenous saline.
Treatment:
Drug: Perineural levobupivacaine
Perineural dexamethasone in addition to levobupivacaine
Experimental group
Description:
Patients will receive levobupivacaine-dexamethasone in interscalene brachial plexus block plus intravenous saline.
Treatment:
Drug: Perineural dexamethasone in addition to levobupivacaine
Intravenous dexamethasone with perineural levobupivacaine
Experimental group
Description:
Patients will receive levobupivacaine plus saline in interscalene brachial plexus block in addition to intravenous dexamethasone.
Treatment:
Drug: Intravenous dexamethasone with perineural levobupivacaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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