Ultrasound-GuidedNCT04908878
Combined PECS II and Transeversus Thoracic Plane Blocks Vs Serratus Anterior Plane Block in Modified Radical Mastectomy
A study testing Pectoral nerve (PECS) block -transversus thoracic plane (TTP) block and Serratus anterior plane (SAP) block in people with Ultrasound-Guided and Transeversus Thoracic Plane Blocks, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the analgesic efficacy of combined ultrasound (US)-guided pectoral nerve (PECS) block II and transversus thoracic plane (TTP) block versus US-guided serratus anterior plane (SAP) block in female patients undergoing modified radical mastectomy. Read more about this study
- Who is it for?
- Ages 21 to 60 years, women only
- Conditions the study is for
- Ultrasound-Guided, Transeversus Thoracic Plane Blocks, Pectoral Nerve (PECS) Block
- What is being tested?
- Pectoral nerve (PECS) block -transversus thoracic plane (TTP) block and Serratus anterior plane (SAP) block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 2 Jun 2022
- 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
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients
- Aged 21-60 years
- ASA physical status I, II
- Scheduled for unilateral modified radical mastectomy
Who cannot join
- Patient refusal.
- Known hypersensitivity to local anesthetics.
- Body mass index > 35 kg /m2.
- Uncooperative or psychiatric patients.
- Infection at the injection site.
- Coagulation disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of Combined Ultrasound-Guided PECS II and Transeversus Thoracic Plane Blocks Versus Ultrasound-Guided Serratus Anterior Plane Block in Modified Radical Mastectomy: A Prospective Randomized Study
The aim of this study is to evaluate the analgesic efficacy of combined ultrasound (US)-guided pectoral nerve (PECS) block II and transversus thoracic plane (TTP) block versus US-guided serratus anterior plane (SAP) block in female patients undergoing modified radical mastectomy.
- Conditions
- Ultrasound-Guided, Transeversus Thoracic Plane Blocks, Pectoral Nerve (PECS) Block, Serratus Anterior Plane Block, Modified Radical Mastectomy
- Being tested
- Pectoral nerve (PECS) block -transversus thoracic plane (TTP) block, Serratus anterior plane (SAP) block
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pectoral nerve (PECS) block -transversus thoracic plane (TTP) blockProcedure or surgery
Patients will receive unilateral US-guided PECS II block and TTP block on the side of the operation after induction of general anesthesia.
Serratus anterior plane (SAP) blockProcedure or surgery
Patients will receive US-guided SAP block after induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group I (pectoral nerve (PECS) block -transversus thoracic plane (TTP) block group) | Experimental | Patients will receive unilateral US-guided PECS II block and TTP block on the side of the operation after induction of general anesthesia. Receives: Procedure: Pectoral nerve (PECS) block -transversus thoracic plane (TTP) block |
| Group II (serratus anterior plane (SAP) block group) | Experimental | Patients will receive US-guided SAP block after induction of general anesthesia. Receives: Procedure: Serratus anterior plane (SAP) block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total amount rescue analgesic consumption (morphine) in the first 24 hours postoperatively.
Rescue analgesia in the form of morphine (3mg IV) will be given if the VAS is ≥ 40, repeated with lock out interval of 5 min guided with the occurrence of complications till the VAS is decreased to less than 40.
Measured: First 24 hours postoperatively.
Secondary outcomes (3)
The degree of postoperative pain
Postoperative pain will be assessed by Visual Analog scale (VAS) on admission to Post-Anesthesia Care unit (PACU) and at 30 minutes and then 1,2,4,6,12,18 and 24 hours postoperative.
VAS (0-100; where 0 represents no pain and 100 represents the worst pain).
Measured: First 24 hours postoperatively.
Time to first rescue analgesia request.
Rescue analgesia in the form of morphine (3mg IV) will be given if the VAS is ≥ 40, repeated with lock out interval of 5 min guided with the occurrence of complications till the VAS is decreased to less than 40.
Measured: First 24 hours postoperatively.
Intraoperative fentanyl consumption.
Additional boluses of fentanyl 0.5 µg /kg will be administered in case of inadequate analgesia that defined as increase of heart rate (HR) and /or mean arterial blood pressure (MAP) more than 20 % from baseline
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start1 Jun 2021
- Primary completion1 Jun 2022
- Study completion2 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound-GuidedStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alshaimaa Soliman Alasrag, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908878
- Sponsor's protocol ID
- 33972/7/20
- Status last verified
- Nov 2022
- First submitted
- 27 May 2021
- Last updated
- 29 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Combined Ultrasound-Guided PECS II and Transeversus Thoracic Plane Blocks Versus Ultrasound-Guided Serratus Anterior Plane Block in Modified Radical Mastectomy: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04908878
- Acronym / sponsor ID
- 33972/7/20
- Conditions
- Ultrasound-Guided, Transeversus Thoracic Plane Blocks, Pectoral Nerve (PECS) Block, Serratus Anterior Plane Block, Modified Radical Mastectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 2 Jun 2022 (actual)
- First posted
- 1 Jun 2021 (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.
The aim of this study is to evaluate the analgesic efficacy of combined ultrasound (US)-guided pectoral nerve (PECS) block II and transversus thoracic plane (TTP) block versus US-guided serratus anterior plane (SAP) block in female patients undergoing modified radical mastectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (pectoral nerve (PECS) block -transversus thoracic plane (TTP) block group) | Experimental | Procedure: Pectoral nerve (PECS) block -transversus thoracic plane (TTP) blockPatients will receive unilateral US-guided PECS II block and TTP block on the side of the operation after induction of general anesthesia. |
| Group II (serratus anterior plane (SAP) block group) | Experimental | Procedure: Serratus anterior plane (SAP) blockPatients will receive US-guided SAP block after induction of general anesthesia. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female patients
- Aged 21-60 years
- ASA physical status I, II
- Scheduled for unilateral modified radical mastectomy
Key exclusion criteria (6 listed)
- Patient refusal.
- Known hypersensitivity to local anesthetics.
- Body mass index > 35 kg /m2.
- Uncooperative or psychiatric patients.
- Infection at the injection site.
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 |
|---|---|---|
| Pectoral nerve (PECS) block -transversus thoracic plane (TTP) blockPatients will receive unilateral US-guided PECS II block and TTP block on the side of the operation after induction of general anesthesia. | Procedure or surgery | Group I (pectoral nerve (PECS) block -transversus thoracic plane (TTP) block group) |
| Serratus anterior plane (SAP) blockPatients will receive US-guided SAP block after induction of general anesthesia. | Procedure or surgery | Group II (serratus anterior plane (SAP) block group) |
Primary outcome
The total amount rescue analgesic consumption (morphine) in the first 24 hours postoperatively.
Time frame: First 24 hours postoperatively.
Rescue analgesia in the form of morphine (3mg IV) will be given if the VAS is ≥ 40, repeated with lock out interval of 5 min guided with the occurrence of complications till the VAS is decreased to less than 40.
3 secondary outcomes
The degree of postoperative pain
Time frame: First 24 hours postoperatively.
Time to first rescue analgesia request.
Time frame: First 24 hours postoperatively.
Intraoperative fentanyl consumption.
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pectoral nerve (PECS) block -transversus thoracic plane (TTP) block and Serratus anterior plane (SAP) block in people with Ultrasound-Guided and Transeversus Thoracic Plane Blocks, run by Tanta 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 4 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: finished, as of the sponsor's last update on 29 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total amount rescue analgesic consumption (morphine) in the first 24 hours postoperatively. (time frame: First 24 hours postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2022.