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A Comparative Study Between Ultrasound Guided Thoracic Paravertebral Block VS Serrartus Anterior Muscle Block in VATS as Regard Their Effectiveness in Post-operative Analgesia

Primary Purpose

Post Operative Pain, Acute

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
thoracic paravertebal block
serratus anterior muscle block
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain, Acute focused on measuring regional anesthesia

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients American Society of Anesthesiologists physical status (ASA) I to II Both sexes. Aged ≥ 20 to ≤ 65years. Scheduled for VATS under general anesthesia. Exclusion Criteria: Patient's refusal. Patients with major spine deformities. Disruption of the local anatomy, secondary, for instance, to the presence of chest drains or surgical emphysema, resulting in difficulty in ultrasound interpretation and distortion of tissue planes. Patients with bleeding disorders and coagulopathy. Infection at the injection site. Known allergy to local anesthetics. Patients with pre-existing myopathy or neuropathy. Ipsilateral diaphragmatic paresis. Tumors in the paravertebral space at the level of injection.

Sites / Locations

  • Faculty of medicine Ain shams universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A: Patients will receive ultrasound guided thoracic paravertebral block

Group B: Patients will receive ultrasound guided serratus anterior muscle block

Arm Description

Group A: Patients will receive ultrasound guided thoraxic paravertebral block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia.

Group B: Patients will receive ultrasound guided serratus anterior muscle block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia.

Outcomes

Primary Outcome Measures

total amount of opioid consumption in the two groups according to change in VAS score
Postoperative pain will be assessed at time of evaluation or at any time the patient is complaining of pain by using visual analog scale (VAS) and VAS more than 4 will be managed by injection of nalbuphine 5mg intravenously as a first rescue analgesia to reduce VAS score ≤ 3 and another titrating dose (2-3 mg nalbuphine) will be considered if the patient is still complaining in order to reach VAS score ≤ 3 (with maximum dose of 10 mg nalbuphine at a time)
visual analog scale (VAS)
Postoperative pain will be assessed at time of evaluation or at any time the patient is complaining of pain by using visual analog scale (VAS) and VAS more than 4 will be managed by injection of nalbuphine 5mg intravenously as a first rescue analgesia to reduce VAS score ≤ 3

Secondary Outcome Measures

The onset of 1st analgesic request
Postoperative pain will be assessed by using visual analog scale (VAS) and VAS more than 4 will be managed by injection of nalbuphine 5mg intravenously as a first rescue analgesia to reduce VAS score ≤ 3. comparison will be done between the two groups in the onset of 1st analgesic request
mean arterial blood pressure of the patients
After surgery, Patients will be observed immediately post-operative at 0 (PACU), and 2, 4, 8, 12, 24 hours after surgery for post-operative pain in form of increasing mean arterial blood pressure as a sign of uncontrolled pain
onset of ambulation
controlling pain postoperatively will help in early ambulation which is a major goal post operative to decrease complications
complication of nerve block
as hematoma , infection , pneumothorax .
heart rate of the patients
After surgery, Patients will be observed immediately post-operative at 0 (PACU), and 2, 4, 8, 12, 24 hours after surgery for post-operative pain in form of increasing heart rate above 90 (pulse per min )as a sign of uncontrolled pain

Full Information

First Posted
June 16, 2023
Last Updated
July 31, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05971368
Brief Title
A Comparative Study Between Ultrasound Guided Thoracic Paravertebral Block VS Serrartus Anterior Muscle Block in VATS as Regard Their Effectiveness in Post-operative Analgesia
Official Title
A Comparative Study Between Ultrasound Guided Thoracic Paravertebral Block VS Ultrasound Guided Serrartus Anterior Muscle Block in Video-assisted Thoracoscopic Surgeries.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 4, 2022 (Actual)
Primary Completion Date
September 2, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams 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
A comparative study between ultrasound guided thoracic paravertebral block VS ultrasound guided serrartus anterior muscle block in video-assisted thoracoscopic surgeries as regard their effectiveness in post-operative analgesia
Detailed Description
The use of loco-regional analgesia is recommended to control postoperative pain after VATS as it allows opioid sparing and facilitates early postoperative rehabilitation. Different loco-regional analgesic techniques could be used to control pain after thoracic surgery such as a paravertebral block, an intercostal block and serratus plane block. In this study, Thoracic paravertebral nerve block will be compared to Serratus anterior nerve block, both will be done Ultrasound guided (USG) using bupivacaine (0.25%) for postoperative analgesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Acute
Keywords
regional anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Group A: Patients will receive ultrasound guided thoraxic paravertebral block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia. Group B: Patients will receive ultrasound guided serratus anterior muscle block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: Patients will receive ultrasound guided thoracic paravertebral block
Arm Type
Active Comparator
Arm Description
Group A: Patients will receive ultrasound guided thoraxic paravertebral block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia.
Arm Title
Group B: Patients will receive ultrasound guided serratus anterior muscle block
Arm Type
Active Comparator
Arm Description
Group B: Patients will receive ultrasound guided serratus anterior muscle block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia.
Intervention Type
Procedure
Intervention Name(s)
thoracic paravertebal block
Intervention Description
o Group A: Patients will receive ultrasound guided thoraxic paravertebral block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia. A high-frequency linear ultrasound probe will be placed between transverse processes from the T4 level (the level of port introduction) in the paramedian plane while patients is in the lateral decubitus position. The transverse processes, superior costotransverse ligaments, and pleura will be well visualized. The block needle (22 gauge) will be advanced until it crosses the superior costotransverse ligament. The prepared 0.25% bupivacaine will be administered at 0.4 mL/kg (max. 40 mL) in the thoracic paravertebral space. Depression of the pleura will be observed as a result of the spread of local anesthetic.
Intervention Type
Procedure
Intervention Name(s)
serratus anterior muscle block
Intervention Description
Group B: Patients will receive ultrasound guided serratus anterior muscle block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia. While the patient is in the supine position, a high-frequency linear ultrasound probe will be placed horizontally on the mid-axillary line at the level of 4th or 5th ribs on the side of the block. The serratus anterior, latissimus dorsi, and intercostal muscles will be identified. The block needle (22-gauge) will be advanced below the serratus anterior muscle (SAM) towards the fifth rib (using in-plane technique). The prepared 0.25% bupivacaine will be administered at 0.4 mL/kg (max. 40 mL) between the SAM and the rib. It will be observed that the solution of local anesthesia will spread between the SAM and the rib.
Primary Outcome Measure Information:
Title
total amount of opioid consumption in the two groups according to change in VAS score
Description
Postoperative pain will be assessed at time of evaluation or at any time the patient is complaining of pain by using visual analog scale (VAS) and VAS more than 4 will be managed by injection of nalbuphine 5mg intravenously as a first rescue analgesia to reduce VAS score ≤ 3 and another titrating dose (2-3 mg nalbuphine) will be considered if the patient is still complaining in order to reach VAS score ≤ 3 (with maximum dose of 10 mg nalbuphine at a time)
Time Frame
the first 24 hours postoperatively
Title
visual analog scale (VAS)
Description
Postoperative pain will be assessed at time of evaluation or at any time the patient is complaining of pain by using visual analog scale (VAS) and VAS more than 4 will be managed by injection of nalbuphine 5mg intravenously as a first rescue analgesia to reduce VAS score ≤ 3
Time Frame
the first 24 hours postoperatively
Secondary Outcome Measure Information:
Title
The onset of 1st analgesic request
Description
Postoperative pain will be assessed by using visual analog scale (VAS) and VAS more than 4 will be managed by injection of nalbuphine 5mg intravenously as a first rescue analgesia to reduce VAS score ≤ 3. comparison will be done between the two groups in the onset of 1st analgesic request
Time Frame
The first 24 hours postoperatively
Title
mean arterial blood pressure of the patients
Description
After surgery, Patients will be observed immediately post-operative at 0 (PACU), and 2, 4, 8, 12, 24 hours after surgery for post-operative pain in form of increasing mean arterial blood pressure as a sign of uncontrolled pain
Time Frame
first 24 hours postoperatively
Title
onset of ambulation
Description
controlling pain postoperatively will help in early ambulation which is a major goal post operative to decrease complications
Time Frame
first 24 hours postoperatively
Title
complication of nerve block
Description
as hematoma , infection , pneumothorax .
Time Frame
first 24 hours postoperatively
Title
heart rate of the patients
Description
After surgery, Patients will be observed immediately post-operative at 0 (PACU), and 2, 4, 8, 12, 24 hours after surgery for post-operative pain in form of increasing heart rate above 90 (pulse per min )as a sign of uncontrolled pain
Time Frame
first 24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients American Society of Anesthesiologists physical status (ASA) I to II Both sexes. Aged ≥ 20 to ≤ 65years. Scheduled for VATS under general anesthesia. Exclusion Criteria: Patient's refusal. Patients with major spine deformities. Disruption of the local anatomy, secondary, for instance, to the presence of chest drains or surgical emphysema, resulting in difficulty in ultrasound interpretation and distortion of tissue planes. Patients with bleeding disorders and coagulopathy. Infection at the injection site. Known allergy to local anesthetics. Patients with pre-existing myopathy or neuropathy. Ipsilateral diaphragmatic paresis. Tumors in the paravertebral space at the level of injection.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
aya gamal abdelhamid, MSC
Phone
(202) 01067206719
Email
ayagamal.3614@gmail.com
Facility Information:
Facility Name
Faculty of medicine Ain shams university
City
Cairo
State/Province
Abbasia
ZIP/Postal Code
1181
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
faculty of medicine faculty of medicine ain shams university
Phone
+202-24346344
Email
it@med.asu.edu.eg
First Name & Middle Initial & Last Name & Degree
Research Ethics Committee
Phone
(202)16857539
Email
rec-fmasu@med.asu.edu.eg
First Name & Middle Initial & Last Name & Degree
AYA GAMAL abdelhamid, master degree

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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A Comparative Study Between Ultrasound Guided Thoracic Paravertebral Block VS Serrartus Anterior Muscle Block in VATS as Regard Their Effectiveness in Post-operative Analgesia

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