Intravenous Versus Perineural Effect Dexamethasone in Interscalene Nerve Block With Levobupivacaine

Intravenous Versus Perineural Dexamethasone in Interscalene Nerve Block With Levobupivacaine for Shoulder and Upper Arm Surgeries

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.

Study Overview

• Status: Unknown
• Conditions: Shoulder Pain
• Intervention / Treatment: Drug: Perineural levobupivacaine; Drug: Perineural dexamethasone in addition to levobupivacaine; Drug: Intravenous dexamethasone with perineural levobupivacaine

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakhlia
    • Mansourah, Dakhlia, Egypt, 050
      • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Perineural levobupivacaine with intravenous saline; Patients will receive levobupivacaine plus saline in interscalene brachial plexus block in addition to intravenous saline.	Drug: Perineural levobupivacaine; Patients will receive 20 ml of 0.25% levobupivacaine plus 2ml saline in interscalene brachial plexus block plus 10 ml intravenous saline.
EXPERIMENTAL: Perineural dexamethasone in addition to levobupivacaine; Patients will receive levobupivacaine-dexamethasone in interscalene brachial plexus block plus intravenous saline.	Drug: Perineural dexamethasone in addition to levobupivacaine; 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.
EXPERIMENTAL: Intravenous dexamethasone with perineural levobupivacaine; Patients will receive levobupivacaine plus saline in interscalene brachial plexus block in addition to intravenous dexamethasone.	Drug: Intravenous dexamethasone with perineural levobupivacaine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of postoperative analgesia	as measured by time to first analgesic requirement.	for 24 hour postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset of Sensory block	Patients will be closely observed until 30 minutes after the end of local anesthetic injection. Block success will be defined as loss of sensation to pinprick in the C4 and C5 sensory dermatome distribution measured 30 minutes after the end of local anesthetic injection. sensory block will be assessed by pin prick test using a 3point scale: • Grade 0 = Normal sensation.; Grade 1 = loss of sensation to pin prick (analgesia).; Grade 2 = loss of sensation to touch (anaesthesia). Onset time for sensory block will be defined as the time interval between the end of local anaesthesia administration and complete sensory block (score 2).	For 30 min after injecting local anesthetic
Duration of sensory block	defined as the time interval between complete sensory block (score 2) and complete resolution of anaesthesia on all nerves (score 0)	within 24 hours after the surgery.
Onset time of motor block	Motor block will be determined according to the modified Bromage scale: Grade 0 = Normal motor function with full flexion and extention of elbow.; Grade 1 = Decrease motor power.; Grade 2 = Complete motor block. Onset time of motor block will be defined as the time interval between end of local anaesthetic administration and complete motor block (grade 2).	For 30 min after injecting local anesthic
Duration of motor block	defined as the time interval between complete motor block (score 2) and complete recovery of motor function of the arm (score 0).	within 24 hours after the surge
Intraoperative Heart rate changes	Heart rate changes	For 3 hours after surgery
Intraoperative Mean arterial blood pressure changes	Mean arterial blood pressure changes	For 3 hours after surgery
Intraoperative analgesic consumption	the intraoperative analgesic dose consumption would be calculated The investigators can use fentanyl as analgesic if the patient required during the surgery ( 50-100 mic)	For 3 hours after surgery
Postoperative heart rate changes		For one hour after admission to the postoperative anesthesia care unit
Postoperative Mean arterial blood pressure changes		For one hour after admission to the postoperative anesthesia care unit
Postoperative peripheral oxygen saturation changes		For one hour after admission to the postoperative anesthesia care unit
Pain score	The VAS is represented with straight line with one end has the anchor " no pain" and it takes 0, while the other end of the line has the anchor " pain as bad as it could be" and it takes 10. The patient will receive the rescue analgesic when the score is more than 4)	Pain after surgery will be assessed using VAS at 1,2,6,12 and 24 hours.
Total analgesic need and the onset of first intravenous analgesia	Total analgesic need to rescue analgesic (pethidine) calculated by mg. And the onset of time for first intravenous analgesia during the 24 hours postoperative by hours.	After transportation of the patient from PACU up to 24 hours postoperative.
Patient satisfaction: 2-point scale	concerning the procedure is assessed using a 2-point scale (1= satisfied, I would want the same anesthesia / analgesia method for the next surgery, 2= unsatisfied, I would want a different anesthesia / analgesia method for the next surgery).	first 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Nahla S El-Ebahnsawy, MD, Professor of Anesthesia and Surgical Intensive Care; Study Director: Hazem E Moawed, MD, assistant professor of Anesthesia and Surgical Intensive Care

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 2, 2019
• Primary Completion (ANTICIPATED): November 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: December 28, 2019
• First Submitted That Met QC Criteria: February 22, 2020
• First Posted (ACTUAL): February 25, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 22, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Anesthetics, Local; Dexamethasone; Dexamethasone acetate; BB 1101; Levobupivacaine
• Other Study ID Numbers: MFM_IRB, MS.18.03.65 -

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The raw data
• IPD Sharing Time Frame: from January 2020 to December 2020
• IPD Sharing Access Criteria: Raw data and results with the registry
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No