NCT05661253

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

December 2, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 22, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

10 months

First QC Date

December 1, 2022

Last Update Submit

August 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • tramadol consumption

    The amount of tramadol consumption at 24

    at 24 hours postoperative

Secondary Outcomes (3)

  • Time of performance

    from ultrasound probe positioning till the end of the block procedure

  • Time to first dose of rescue analgesia

    during the first postoperative 24 hours

  • Patient satisfaction

    at 24 hous post operative

Study Arms (3)

Control group

NO INTERVENTION

will take general anesthesia without nerve block

SAP block group

ACTIVE COMPARATOR

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

modified SAP block group

ACTIVE COMPARATOR

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

patients will receive conventional serratus anterior plane block with a volume of 25 ml of bupivacaine 0.25% followed by induction of general anesthesia,

SAP block group

patients will receive modified serratus anterior plane block with a volume of 25 ml of bupivacaine 0.25% followed by induction of general anesthesia.

modified SAP block group

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heba M Fathi

Zagazig, 44519, Egypt

RECRUITING

Related Publications (1)

  • Abd Ellatif SE, Galal Eldin AM, Ali ES, Fathi HM. Ultrasound-guided modified versus conventional serratus anterior plane block as a preemptive analgesic for unilateral video-assisted thoracoscopic surgery. BMC Anesthesiol. 2025 Aug 29;25(1):435. doi: 10.1186/s12871-025-03314-5.

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Heba M Fathi

    faculty of human medicine ,zagazig university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof/Dr

Study Record Dates

First Submitted

December 1, 2022

First Posted

December 22, 2022

Study Start

December 2, 2022

Primary Completion

October 2, 2023

Study Completion

October 30, 2023

Last Updated

August 29, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations