Modified Versus Conventional Serratus Anterior Plane Block

Sponsor

Zagazig University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05661253

Collaborator

(none)

Enrollment

Location

Arms

6.9

Anticipated Duration (Months)

14.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain, Acute	Drug: 25 ml of bupivacaine 0.25% via serratus anterior block Drug: 25 ml of bupivacaine 0.25% via modified serratus anterior palne block	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

99 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 2, 2022

Anticipated Primary Completion Date :

Jun 2, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

tramadol consumption [at 24 hours postoperative]
The amount of tramadol consumption at 24

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Heba M Fathi	Zagazig		Egypt	44519

Sponsors and Collaborators

Zagazig University

Investigators

Principal Investigator: Heba M Fathi, faculty of human medicine ,zagazig university

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Heba M Fathi, prof/Dr, Zagazig University

ClinicalTrials.gov Identifier:

NCT05661253

Other Study ID Numbers:

ZU-IRB # 10061

First Posted:

Dec 22, 2022

Last Update Posted:

Dec 22, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Acute Pain

Bupivacaine

Study Results

No Results Posted as of Dec 22, 2022