Postoperative Pain, AcuteNCT05661253
Modified Versus Conventional Serratus Anterior Plane Block
A study testing 25 ml of bupivacaine 0.25% via serratus anterior block and 25 ml of bupivacaine 0.25% via modified serratus anterior palne block in people with Postoperative Pain, Acute, run by Zagazig University at 1 site in Egypt.
Trial summary
comparing preemptive analgesia with ultrasound guided modified serratus anterior plane block versus ultrasound guided serratus anterior plane block Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Acute
- What is being tested?
- 25 ml of bupivacaine 0.25% via serratus anterior block and 25 ml of bupivacaine 0.25% via modified serratus anterior palne block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Dec 2022to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Heba M Fathi
Zagazig, 44519
Heba M Fathi, M.D, 002-01000143938, heba_elgendi@yahoo.com
About this study
Official title: 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
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
- Conditions
- Postoperative Pain, Acute
- Being tested
- 25 ml of bupivacaine 0.25% via serratus anterior block, 25 ml of bupivacaine 0.25% via modified serratus anterior palne block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25 ml of bupivacaine 0.25% via serratus anterior blockDrug
patients will receive conventional serratus anterior plane block with a volume of 25 ml of bupivacaine 0.25% followed by induction of general anesthesia,
25 ml of bupivacaine 0.25% via modified serratus anterior palne blockDrug
patients will receive modified serratus anterior plane block with a volume of 25 ml of bupivacaine 0.25% followed by induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| 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. . Receives: 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 . Receives: Drug: 25 ml of bupivacaine 0.25% via modified serratus anterior palne block |
What is being measured
The primary outcome is the main question the study is designed to answer.
tramadol consumption
The amount of tramadol consumption at 24
Measured: at 24 hours postoperative
Secondary outcomes (3)
Time of performance
Time of performance of block defined as time from ultrasound probe positioning till the end of the block procedure
Measured: 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
Measured: 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.
Measured: at 24 hous post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start2 Dec 2022
- Primary completion2 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Heba M Fathi, Zagazig University
- Investigators
- Heba M Fathi, Principal investigator, faculty of human medicine ,zagazig university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661253
- Sponsor's protocol ID
- ZU-IRB # 10061
- Status last verified
- Aug 2023
- First submitted
- 1 Dec 2022
- Last updated
- 29 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40883665
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Modified Versus Conventional Serratus Anterior Plane Block as a Preemptive Analgesia for Unilateral Video-Assisted Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT05661253
- Acronym / sponsor ID
- ZU-IRB # 10061
- Conditions
- Postoperative Pain, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 2 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
comparing preemptive analgesia with ultrasound guided modified serratus anterior plane block versus ultrasound guided serratus anterior plane 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –will take general anesthesia without nerve block |
| SAP block group | Active comparator | Drug: 25 ml of bupivacaine 0.25% via serratus anterior blockAfter 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. . |
| modified SAP block group | Active comparator | Drug: 25 ml of bupivacaine 0.25% via modified serratus anterior palne blockThe 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 . |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient consent.
- both sex.
- Age: 21-70 years old.
- BMI: 18- 30 kg/m2
- ASA: I and II.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 25 ml of bupivacaine 0.25% via serratus anterior blockpatients will receive conventional serratus anterior plane block with a volume of 25 ml of bupivacaine 0.25% followed by induction of general anesthesia, | Drug | SAP block group |
| 25 ml of bupivacaine 0.25% via modified serratus anterior palne blockpatients will receive modified serratus anterior plane block with a volume of 25 ml of bupivacaine 0.25% followed by induction of general anesthesia. | Drug | modified SAP block group |
Primary outcome
tramadol consumption
Time frame: at 24 hours postoperative
The amount of tramadol consumption at 24
3 secondary outcomes
Time of performance
Time frame: from ultrasound probe positioning till the end of the block procedure
Time to first dose of rescue analgesia
Time frame: during the first postoperative 24 hours
Patient satisfaction
Time frame: at 24 hous post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Derived from this study: PubMed 40883665Abd 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heba M Fathi principal investigator
faculty of human medicine ,zagazig university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 25 ml of bupivacaine 0.25% via serratus anterior block and 25 ml of bupivacaine 0.25% via modified serratus anterior palne block in people with Postoperative Pain, Acute, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heba M Fathi (002-01000143938, heba_elgendi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tramadol consumption (time frame: at 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05661253, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.