Intravenous Versus Perineural Effect Dexamethasone in Interscalene Nerve Block With Levobupivacaine

NCT04284007 | Unknown DMC

• 1 other identifier: MFM_IRB, MS.18.03.65 -
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• Duration of postoperative analgesia

  as measured by time to first analgesic requirement.

  for 24 hour postoperatively

Secondary Outcomes (13)

• Onset of Sensory block

  For 30 min after injecting local anesthetic

• Duration of sensory block

  within 24 hours after the surgery.

• Onset time of motor block

  For 30 min after injecting local anesthic

• Duration of motor block

  within 24 hours after the surge

• Intraoperative Heart rate changes

  For 3 hours after surgery

Study Arms (3)

Perineural levobupivacaine with intravenous saline

ACTIVE COMPARATOR

Patients will receive levobupivacaine plus saline in interscalene brachial plexus block in addition to intravenous saline.

Drug: Perineural levobupivacaine

Perineural dexamethasone in addition to levobupivacaine

EXPERIMENTAL

Patients will receive levobupivacaine-dexamethasone in interscalene brachial plexus block plus intravenous saline.

Drug: Perineural dexamethasone in addition to levobupivacaine

Intravenous dexamethasone with perineural levobupivacaine

EXPERIMENTAL

Patients will receive levobupivacaine plus saline in interscalene brachial plexus block in addition to intravenous dexamethasone.

Drug: Intravenous dexamethasone with perineural levobupivacaine

Interventions

Perineural levobupivacaine DRUG

Patients will receive 20 ml of 0.25% levobupivacaine plus 2ml saline in interscalene brachial plexus block plus 10 ml intravenous saline.

Perineural levobupivacaine with intravenous saline

Perineural dexamethasone in addition to levobupivacaine DRUG

Patients will receive 20 ml of 0.25% levobupivacaine plus 4mg dexamethasone diluted in 2 ml saline in interscalene brachial plexus block plus 10 ml intravenous saline.

Perineural dexamethasone in addition to levobupivacaine

Intravenous dexamethasone with perineural levobupivacaine DRUG

Patients will receive 20 ml of 0.25% levobupivacaine plus 2ml saline in interscalene brachial plexus block plus 4 mg intravenous dexamethasone diluted in 10 ml saline.

Intravenous dexamethasone with perineural levobupivacaine

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Dakhlia, 050, Egypt

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nahla S El-Ebahnsawy, MD

  Professor of Anesthesia and Surgical Intensive Care

  STUDY CHAIR

• Hazem E Moawed, MD

  Assistant Professor of Anesthesia and Surgical Intensive Care

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double-blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2019
• First Posted: February 25, 2020
• Study Start: December 2, 2019
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: from January 2020 to December 2020
• Access Criteria: Raw data and results with the registry

Locations

EG (1)