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Neostigmine for Ultrasound Guided Supraclavicular Brachial Plexus Block

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound- guided supraclavicular brachial plexus block
Sponsored by
ABEER HASSANIN
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postoperative Pain focused on measuring Neostigmine, Bupivacaine, Supraclavicular brachial plexus block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. ASA ( I-II)
  2. Age: from ≥18 years
  3. Sex: male or female
  4. type of operation : Forearm Orthopedic surgeries
  5. Type of anaesthesia : supraclavicular brachial plexus block
  6. Duration of operation : 60-90 min

Exclusion Criteria:

  1. Patient refusal for the procedure
  2. Any bleeding tendency
  3. Neurological deficits involving brachial plexus
  4. Patients with allergy to local anesthetics
  5. Local infection at the site of injection
  6. Patients on any sedatives or antipsychotics
  7. Body mass index >35.

Sites / Locations

  • Minya university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control group

Neostigmine group

Arm Description

This group received supraclavicular block using 25mL of 0. 5% bupivacaine and 1 mL normal saline

This group received 25 mL 0. 5% bupivacaine and 1 mL neostigmine (0.5 mg)

Outcomes

Primary Outcome Measures

The onset of sensory blockade
Onset time for sensory block was defined as the time interval between the end of local anesthetic administration untill complete sensory block by minutes
The onset of motor blockade
Onset time for motor block was defined as the time interval between the end of local anesthetic administration until complete motor block by minutes
Duration of sensory blockade
Duration of sensory block was defined as the time interval between the complete sensory block and complete resolution of anesthesia on all the nerves by hours
Duration of motor blockade
the time interval from complete motor block to complete recovery of motor function of hand and forearm by hours

Secondary Outcome Measures

Duration of analgesia (first request for analgesic)
The time from local anesthetic administration to the patient's first request for analgesic medication by hours
Visual analogue pain score
Pain intensity was assessed using Visual analogue pain score. The Visual analogue pain score is consisted of a straight ,vertical 10-cm line; the bottom point represented "no pain"=(0 cm) and the top "the worst pain you could ever have =(10 cm)

Full Information

First Posted
June 14, 2019
Last Updated
August 6, 2019
Sponsor
ABEER HASSANIN
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1. Study Identification

Unique Protocol Identification Number
NCT04000100
Brief Title
Neostigmine for Ultrasound Guided Supraclavicular Brachial Plexus Block
Official Title
Effect OF Adding Neostigmine to Bupivacaine for Ultrasound Guided Supraclavicular Brachial Plexus Block in Forearm Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
July 15, 2018 (Actual)
Primary Completion Date
January 15, 2019 (Actual)
Study Completion Date
January 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
ABEER HASSANIN

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Patients were randomly allocated into Two equal study groups each contain (40) patients : Patients in Group A received supraclavicular block using 25mL of 0. 5% bupivacaine and 1 mL normal saline and patients in Group B received 25 mL 0. 5% bupivacaine and 1 mL neostigmine (0.5 mg). The investigators found that neostigmine when used as an adjuvant to bupivacaine in ultrasound guided supraclavicular brachial plexus block has advantage over bupivacaine alone especially in the quality of sensory block and provide safe and effective post-operative analgesia in patients undergoing forearm surgeries
Detailed Description
All patients were assessed with regards to: Hemodynamics (heart rate, Bp) and oxygen saturation were recorded preoperatively just before the block as a baseline value, immediately after the block 5, 20, 30,40,45 , 60 minutes during the operative time and 1, 2, 4, 6, 9 and 12 hours after end of operation. Onset time of sensory block, Onset time of motor block, Duration of sensory block, and Duration of motor block. Pain assessment using a scoring system based on the visual analogue pain scale(VAS) measured at the following time intervals 0, 2, 4, 6, 9, 12 and 24 post operatively, time to first analgesic requirement (in hours) and total analgesic consumption was monitored in the two groups for 24 hours in ward. The incidence of adverse effects whether related to the drugs used in the technique or related to the technique itself were recorded. The results of this study found that demographic (age, sex, weight and ASA classification and surgical duration were statistically insignificant between the two groups. Hemodynamics (HR and Bp) were statistically significant between the groups .They were lower in Neostigmine groups. As regard onset of sensory and motor block were clinically and significantly earlier in group B than group A ( p < 0,05) and the same for duration of sensory and motor block were clinically and significantly longer in group B than in group A ( P < 0,05 ). Regarding Visual Analogue Pain Scale (VAS), while comparing the two groups, the differences were significant at 9 and 12 hours after surgery for the favor of the neostigmine groups . The time to first analgesic request was significantly longer in group B than group A.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Neostigmine, Bupivacaine, Supraclavicular brachial plexus block

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
This group received supraclavicular block using 25mL of 0. 5% bupivacaine and 1 mL normal saline
Arm Title
Neostigmine group
Arm Type
Active Comparator
Arm Description
This group received 25 mL 0. 5% bupivacaine and 1 mL neostigmine (0.5 mg)
Intervention Type
Procedure
Intervention Name(s)
ultrasound- guided supraclavicular brachial plexus block
Intervention Description
Patient lie down supine with head turned 45 degrees to the contralateral side and ipsilateral arm adducted gently by the assistant and the shoulder kept down with flexed elbow. After sterile preparation of the skin and the ultrasound probe (12 MHz probe) were used, the brachial plexus was visualized by placing the transducer in the sagittal plane in the supraclavicular fossa behind the middle-third of the clavicle. Two distinct appearances of the brachial plexus was seen at the supraclavicular region, it either appeared as 3 hypoechoic circles with hyperechoic outer rings or as a grape like cluster of 5 to 6 hypoechoic circles, located lateral and superior to the subclavian artery between the anterior and middle scalene muscles at the lower cervical region figure
Primary Outcome Measure Information:
Title
The onset of sensory blockade
Description
Onset time for sensory block was defined as the time interval between the end of local anesthetic administration untill complete sensory block by minutes
Time Frame
Every 2 minutes for 30 minutes
Title
The onset of motor blockade
Description
Onset time for motor block was defined as the time interval between the end of local anesthetic administration until complete motor block by minutes
Time Frame
Every 2 minutes for 30 minutes
Title
Duration of sensory blockade
Description
Duration of sensory block was defined as the time interval between the complete sensory block and complete resolution of anesthesia on all the nerves by hours
Time Frame
Every 1 hour for 24 hours
Title
Duration of motor blockade
Description
the time interval from complete motor block to complete recovery of motor function of hand and forearm by hours
Time Frame
Every 1 hour for 24 hours
Secondary Outcome Measure Information:
Title
Duration of analgesia (first request for analgesic)
Description
The time from local anesthetic administration to the patient's first request for analgesic medication by hours
Time Frame
Every 30 minutes for 4 hours then every 2 hours for 24 hours
Title
Visual analogue pain score
Description
Pain intensity was assessed using Visual analogue pain score. The Visual analogue pain score is consisted of a straight ,vertical 10-cm line; the bottom point represented "no pain"=(0 cm) and the top "the worst pain you could ever have =(10 cm)
Time Frame
2,4,6,8,12,16,20 and 24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA ( I-II) Age: from ≥18 years Sex: male or female type of operation : Forearm Orthopedic surgeries Type of anaesthesia : supraclavicular brachial plexus block Duration of operation : 60-90 min Exclusion Criteria: Patient refusal for the procedure Any bleeding tendency Neurological deficits involving brachial plexus Patients with allergy to local anesthetics Local infection at the site of injection Patients on any sedatives or antipsychotics Body mass index >35.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebrahim Abbas, MD
Organizational Affiliation
faculty of medicine
Official's Role
Study Director
Facility Information:
Facility Name
Minya university hospital
City
Minya
ZIP/Postal Code
611111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all data can be shared
IPD Sharing Time Frame
From now
IPD Sharing Access Criteria
abeerhassanin@yahoo.com

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Neostigmine for Ultrasound Guided Supraclavicular Brachial Plexus Block

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