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Intravenous Versus Perineural Effect Dexamethasone in Interscalene Nerve Block With Levobupivacaine

Primary Purpose

Shoulder Pain

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Perineural levobupivacaine
Perineural dexamethasone in addition to levobupivacaine
Intravenous dexamethasone with perineural levobupivacaine
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Shoulder Pain

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Mansoura University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Perineural levobupivacaine with intravenous saline

Perineural dexamethasone in addition to levobupivacaine

Intravenous dexamethasone with perineural levobupivacaine

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Duration of postoperative analgesia
as measured by time to first analgesic requirement.

Secondary Outcome Measures

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).
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)
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).
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).
Intraoperative Heart rate changes
Heart rate changes
Intraoperative Mean arterial blood pressure changes
Mean arterial blood pressure changes
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)
Postoperative heart rate changes
Postoperative Mean arterial blood pressure changes
Postoperative peripheral oxygen saturation changes
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)
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.
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).

Full Information

First Posted
December 28, 2019
Last Updated
February 22, 2020
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT04284007
Brief Title
Intravenous Versus Perineural Effect Dexamethasone in Interscalene Nerve Block With Levobupivacaine
Official Title
Intravenous Versus Perineural Dexamethasone in Interscalene Nerve Block With Levobupivacaine for Shoulder and Upper Arm Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 2, 2019 (Actual)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Double-blind
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Perineural levobupivacaine with intravenous saline
Arm Type
Active Comparator
Arm Description
Patients will receive levobupivacaine plus saline in interscalene brachial plexus block in addition to intravenous saline.
Arm Title
Perineural dexamethasone in addition to levobupivacaine
Arm Type
Experimental
Arm Description
Patients will receive levobupivacaine-dexamethasone in interscalene brachial plexus block plus intravenous saline.
Arm Title
Intravenous dexamethasone with perineural levobupivacaine
Arm Type
Experimental
Arm Description
Patients will receive levobupivacaine plus saline in interscalene brachial plexus block in addition to intravenous dexamethasone.
Intervention Type
Drug
Intervention Name(s)
Perineural levobupivacaine
Intervention Description
Patients will receive 20 ml of 0.25% levobupivacaine plus 2ml saline in interscalene brachial plexus block plus 10 ml intravenous saline.
Intervention Type
Drug
Intervention Name(s)
Perineural dexamethasone in addition to levobupivacaine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Intravenous dexamethasone with perineural levobupivacaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Duration of postoperative analgesia
Description
as measured by time to first analgesic requirement.
Time Frame
for 24 hour postoperatively
Secondary Outcome Measure Information:
Title
Onset of Sensory block
Description
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).
Time Frame
For 30 min after injecting local anesthetic
Title
Duration of sensory block
Description
defined as the time interval between complete sensory block (score 2) and complete resolution of anaesthesia on all nerves (score 0)
Time Frame
within 24 hours after the surgery.
Title
Onset time of motor block
Description
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).
Time Frame
For 30 min after injecting local anesthic
Title
Duration of motor block
Description
defined as the time interval between complete motor block (score 2) and complete recovery of motor function of the arm (score 0).
Time Frame
within 24 hours after the surge
Title
Intraoperative Heart rate changes
Description
Heart rate changes
Time Frame
For 3 hours after surgery
Title
Intraoperative Mean arterial blood pressure changes
Description
Mean arterial blood pressure changes
Time Frame
For 3 hours after surgery
Title
Intraoperative analgesic consumption
Description
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)
Time Frame
For 3 hours after surgery
Title
Postoperative heart rate changes
Time Frame
For one hour after admission to the postoperative anesthesia care unit
Title
Postoperative Mean arterial blood pressure changes
Time Frame
For one hour after admission to the postoperative anesthesia care unit
Title
Postoperative peripheral oxygen saturation changes
Time Frame
For one hour after admission to the postoperative anesthesia care unit
Title
Pain score
Description
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)
Time Frame
Pain after surgery will be assessed using VAS at 1,2,6,12 and 24 hours.
Title
Total analgesic need and the onset of first intravenous analgesia
Description
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.
Time Frame
After transportation of the patient from PACU up to 24 hours postoperative.
Title
Patient satisfaction: 2-point scale
Description
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).
Time Frame
first 24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nahla S El-Ebahnsawy, MD
Organizational Affiliation
Professor of Anesthesia and Surgical Intensive Care
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hazem E Moawed, MD
Organizational Affiliation
Assistant Professor of Anesthesia and Surgical Intensive Care
Official's Role
Study Director
Facility Information:
Facility Name
Mansoura University
City
Mansourah
State/Province
Dakhlia
ZIP/Postal Code
050
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Intravenous Versus Perineural Effect Dexamethasone in Interscalene Nerve Block With Levobupivacaine

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