Modified Versus Conventional Serratus Anterior Plane Block

Ultrasound Guided Modified Versus Conventional Serratus Anterior Plane Block as a Preemptive Analgesia for Unilateral Video-Assisted Thoracoscopic Surgery

comparing preemptive analgesia with ultrasound guided modified serratus anterior plane block versus ultrasound guided serratus anterior plane block

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain, Acute
• Intervention / Treatment: Drug: 25 ml of bupivacaine 0.25% via serratus anterior block; Drug: 25 ml of bupivacaine 0.25% via modified serratus anterior palne 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

• Study Type: Interventional
• Enrollment (Estimated): 99
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heba M Fathi; Phone Number: 002-01000143938; Email: heba_elgendi@yahoo.com

Study Locations

• Egypt
  • Zagazig, Egypt, 44519
    • Recruiting
    • Heba M Fathi
    • Contact: Heba M Fathi, M.D; Phone Number: 002-01000143938; Email: heba_elgendi@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 56 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; will take general anesthesia without nerve block
Active Comparator: SAP block group; 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. .	Drug: 25 ml of bupivacaine 0.25% via serratus anterior block; patients will receive conventional serratus anterior plane block with a volume of 25 ml of bupivacaine 0.25% followed by induction of general anesthesia,
Active Comparator: modified SAP block group; 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 .	Drug: 25 ml of bupivacaine 0.25% via modified serratus anterior palne block; patients will receive modified serratus anterior plane block with a volume of 25 ml of bupivacaine 0.25% followed by induction of general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tramadol consumption	The amount of tramadol consumption at 24	at 24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of performance	Time of performance of block defined as time from ultrasound probe positioning till the end of the block procedure	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	during the first postoperative 24 hours
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.	at 24 hous post operative

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Heba M Fathi, faculty of human medicine ,zagazig university

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2022
• Primary Completion (Estimated): October 2, 2023
• Study Completion (Estimated): October 30, 2023

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): December 22, 2022

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 26, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: ZU-IRB # 10061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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