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Modified Versus Conventional Serratus Anterior Plane Block

Primary Purpose

Postoperative Pain, Acute

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
25 ml of bupivacaine 0.25% via serratus anterior block
25 ml of bupivacaine 0.25% via modified serratus anterior palne block
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain, Acute

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patient consent. both sex. Age: 21-70 years old. BMI: 18- 30 kg/m2 ASA: I and II. Scheduled for elective unilateral Video-Assisted thoracoscopy under general anesthesia. Exclusion Criteria: History of allergy to the local anesthesia agents used in this study, Skin lesion at needle insertion site, Those receiving anticoagulant therapy or having bleeding disorders Patients with history of chronic pain and taking analgesics, Patients with sepsis and Significant cardiac, liver or renal diseases Uncooperative patients or with psychiatric disorders.

Sites / Locations

  • Heba M FathiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Control group

SAP block group

modified SAP block group

Arm Description

will take general anesthesia without nerve block

After sterilization of the skin and draping, the high frequency linear probe of Sonosite M Turbo ultrasonography (FUJIFIM sonosite, Inc., Bothell, WA, USA) will be placed at the level of the midclavicular line in a sagittal plane. The second rib will be recognized at the axillary artery. The probe will be moved downward to count the ribs until the level of the fifth rib in the mid-axillary line. At this time, the latissimus dorsi muscle (lying superficial) and the serratus anterior muscle (lying deep) will be clearly visualized under ultrasound . Next, A 22-gauge, 80 mm needle (Stimuplex D, B-Braun, Germany) will be inserted in plane relative to the ultrasound probe between the latissimus dorsi and the serratus anterior muscle. After confirming negative aspiration of blood, 1 ml normal saline will be injected for hydro-dissection sign to verify the needle tip, then a volume of 25 ml 0.25% bupivacaine will be injected superficially to serratus anterior muscle. .

The patient will be placed in the lateral decubitus position according to the selected site of surgical intervention. After sterilization of the skin and draping, the high frequency linear probe of Sonosite M Turbo ultrasonography ( FUJIFIM sonosite, Inc., Bothell, WA, USA) will be placed horizontally midway between tip of the scapula and posterior axillary line to identify the view of latissimus dorsi(lying superficial) and serratus anterior muscle(lying deep) over either the sixth or seventh rib. A 22-gauge, 80 mm needle (Stimuplex D, B-Braun, Germany) will be inserted in plane relative to the ultrasound probe from posteromedial to anterolateral direction toward posterior axillary line till reaching the interfacial plane between latissimus dorsi and serratus anterior muscle . After confirming negative aspiration of blood, 1 ml normal saline will be injected for hydro-dissection sign to verify the needle tip, then a volume of 25 ml 0.25% bupivacaine will be injected .

Outcomes

Primary Outcome Measures

tramadol consumption
The amount of tramadol consumption at 24

Secondary Outcome Measures

Time of performance
Time of performance of block defined as time from ultrasound probe positioning till the end of the block procedure
Time to first dose of rescue analgesia
Time to first dose of rescue analgesia (VAS > 3) after surgery
Patient satisfaction
Patient satisfaction with analgesia in the first 24hours postoperative hours will be Likert scale where 5 is very satisfied and 0 is very dissatisfied.

Full Information

First Posted
December 1, 2022
Last Updated
August 26, 2023
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT05661253
Brief Title
Modified Versus Conventional Serratus Anterior Plane Block
Official Title
Ultrasound Guided Modified Versus Conventional Serratus Anterior Plane Block as a Preemptive Analgesia for Unilateral Video-Assisted Thoracoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2022 (Actual)
Primary Completion Date
October 2, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

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
comparing preemptive analgesia with ultrasound guided modified serratus anterior plane block versus ultrasound guided serratus anterior plane block
Detailed Description
comparing the quality of postoperative analgesia and opioid consumption in patients undergoing Video-Assisted Thoracoscopic Surgery when using preemptive analgesia with ultrasound guided modified serratus anterior plane block versus ultrasound guided serratus anterior plane block

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
99 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
will take general anesthesia without nerve block
Arm Title
SAP block group
Arm Type
Active Comparator
Arm Description
After sterilization of the skin and draping, the high frequency linear probe of Sonosite M Turbo ultrasonography (FUJIFIM sonosite, Inc., Bothell, WA, USA) will be placed at the level of the midclavicular line in a sagittal plane. The second rib will be recognized at the axillary artery. The probe will be moved downward to count the ribs until the level of the fifth rib in the mid-axillary line. At this time, the latissimus dorsi muscle (lying superficial) and the serratus anterior muscle (lying deep) will be clearly visualized under ultrasound . Next, A 22-gauge, 80 mm needle (Stimuplex D, B-Braun, Germany) will be inserted in plane relative to the ultrasound probe between the latissimus dorsi and the serratus anterior muscle. After confirming negative aspiration of blood, 1 ml normal saline will be injected for hydro-dissection sign to verify the needle tip, then a volume of 25 ml 0.25% bupivacaine will be injected superficially to serratus anterior muscle. .
Arm Title
modified SAP block group
Arm Type
Active Comparator
Arm Description
The patient will be placed in the lateral decubitus position according to the selected site of surgical intervention. After sterilization of the skin and draping, the high frequency linear probe of Sonosite M Turbo ultrasonography ( FUJIFIM sonosite, Inc., Bothell, WA, USA) will be placed horizontally midway between tip of the scapula and posterior axillary line to identify the view of latissimus dorsi(lying superficial) and serratus anterior muscle(lying deep) over either the sixth or seventh rib. A 22-gauge, 80 mm needle (Stimuplex D, B-Braun, Germany) will be inserted in plane relative to the ultrasound probe from posteromedial to anterolateral direction toward posterior axillary line till reaching the interfacial plane between latissimus dorsi and serratus anterior muscle . After confirming negative aspiration of blood, 1 ml normal saline will be injected for hydro-dissection sign to verify the needle tip, then a volume of 25 ml 0.25% bupivacaine will be injected .
Intervention Type
Drug
Intervention Name(s)
25 ml of bupivacaine 0.25% via serratus anterior block
Intervention Description
patients will receive conventional serratus anterior plane block with a volume of 25 ml of bupivacaine 0.25% followed by induction of general anesthesia,
Intervention Type
Drug
Intervention Name(s)
25 ml of bupivacaine 0.25% via modified serratus anterior palne block
Intervention Description
patients will receive modified serratus anterior plane block with a volume of 25 ml of bupivacaine 0.25% followed by induction of general anesthesia.
Primary Outcome Measure Information:
Title
tramadol consumption
Description
The amount of tramadol consumption at 24
Time Frame
at 24 hours postoperative
Secondary Outcome Measure Information:
Title
Time of performance
Description
Time of performance of block defined as time from ultrasound probe positioning till the end of the block procedure
Time Frame
from ultrasound probe positioning till the end of the block procedure
Title
Time to first dose of rescue analgesia
Description
Time to first dose of rescue analgesia (VAS > 3) after surgery
Time Frame
during the first postoperative 24 hours
Title
Patient satisfaction
Description
Patient satisfaction with analgesia in the first 24hours postoperative hours will be Likert scale where 5 is very satisfied and 0 is very dissatisfied.
Time Frame
at 24 hous post operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient consent. both sex. Age: 21-70 years old. BMI: 18- 30 kg/m2 ASA: I and II. Scheduled for elective unilateral Video-Assisted thoracoscopy under general anesthesia. Exclusion Criteria: History of allergy to the local anesthesia agents used in this study, Skin lesion at needle insertion site, Those receiving anticoagulant therapy or having bleeding disorders Patients with history of chronic pain and taking analgesics, Patients with sepsis and Significant cardiac, liver or renal diseases Uncooperative patients or with psychiatric disorders.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heba M Fathi
Phone
002-01000143938
Email
heba_elgendi@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heba M Fathi
Organizational Affiliation
faculty of human medicine ,zagazig university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heba M Fathi
City
Zagazig
ZIP/Postal Code
44519
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heba M Fathi, M.D
Phone
002-01000143938
Email
heba_elgendi@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Modified Versus Conventional Serratus Anterior Plane Block

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