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RecruitingNCT05661253Updated Aug 29, 2023

Modified Versus Conventional Serratus Anterior Plane Block

An interventional study of 25 ml of bupivacaine 0.25% via serratus anterior block and 25 ml of bupivacaine 0.25% via modified serratus anterior palne block in Postoperative Pain, Acute, sponsored by Zagazig University. Recruiting at 1 site in Egypt. Open to participants aged 21 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-29.

Sponsored by Zagazig University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2023, 3 years ago, but the record still lists the study as recruiting.
  • Started Dec 2022; still recruiting 3 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
99
Allocation
Randomized
Ages
21 Years to 60 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Postoperative Pain, Acute

Browse trials for

03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 99 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 60 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
99 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Drug25 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,

  • Drug25 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.

06

What researchers measure

Primary outcomes

  1. tramadol consumption

    The amount of tramadol consumption at 24

    Time frame: at 24 hours postoperative

Secondary outcomes

  1. Time of performance

    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

  2. Time to first dose of rescue analgesia

    Time to first dose of rescue analgesia (VAS \> 3) after surgery

    Time frame: during the first postoperative 24 hours

  3. 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.

    Time frame: at 24 hous post operative

07

Study locations

1 of 1 sites recruiting
  • Heba M Fathi
    Zagazig, 44519, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05661253
Lead sponsor
Zagazig University
Responsible party
Heba M Fathi (prof/Dr, Zagazig University) — Principal investigator
First posted
Dec 22, 2022
Start date
Dec 2, 2022
Primary completion
Oct 2, 2023 (estimated)
Completion
Oct 30, 2023 (estimated)
Last update
Aug 29, 2023

Study contacts

Heba M Fathi
Contact
heba_elgendi@yahoo.com
002-01000143938
Heba M Fathi
principal investigator · faculty of human medicine ,zagazig university

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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