Postoperative PainNCT06478654
Modified Pectoral Nerve Block Vs Thoracic Erector Spinae Plane Block for Analgesia for Aesthetic Breast Surgeries
A study testing Bilateral Modified Pectoral Nerve Block (PECS II). and Bilateral Thoracic Erector spinae plane block (ESPB). in people with Postoperative Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate The Effectiveness of Ultrasound Guided Modified Pectoral Nerve Block (PECS II) versus Thoracic Erector Spinae Plane Block (ESPB) for postoperative Analgesia in cases of aesthetic breast surgeries. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bilateral Modified Pectoral Nerve Block (PECS II). and Bilateral Thoracic Erector spinae plane block (ESPB).
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 Oct 2024
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females aged ≥21 years' old.
- BMI ≤35.
- Patients with ASA I \& II.
- Scheduled for one of the aesthetic breast surgeries.
Who cannot join
- Patients refusal.
- Contraindications to regional anaesthesia as bleeding disorders, spine deformity and local infection.
- Patients with unstable cardiovascular disease.
- Emergency surgery.
- Patients with chronic pain.
- History of allergy to the medications used in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Bilateral Modified Pectoral Nerve (PECS II) Block Vs Bilateral Thoracic Erector Spinae Plane (ESP) Block for Postoperative Analgesia for Aesthetic Breast Surgeries
The aim of this study is to evaluate The Effectiveness of Ultrasound Guided Modified Pectoral Nerve Block (PECS II) versus Thoracic Erector Spinae Plane Block (ESPB) for postoperative Analgesia in cases of aesthetic breast surgeries.
Read the detailed description
Preoperative settings:
All the patients will be fasting for solid food for at least 6 hours and for clear fluids for 4 hours before surgery and will be instructed about Numeric Rating Scale (NRS) and its interpretation.
Intravenous access will be inserted, premedication with midazolam 3 mg will be done. On arrival to operating room, routine monitoring including electrocardiography (ECG), non-invasive arterial blood pressure(NIBP) and pulse oximetry will be used. The mean arterial blood pressure (MAP)and heart rate (HR) will be recorded before induction of general anaesthesia (baseline).
Intraoperative \& postoperative settings :
A prophylactic antibiotic will be given after skin sensetivity test then General Intravenous anaesthesia induction will be done. Patient inductions by Propofol (2 mg/kg), Atracurium 0.5 mg/kg and Fentanyl 1 µg/kg. Endotracheal intubation will be settled then Patients will be mechanically ventilated and ventilator parameters will be set to keep end tidal CO2 between 30-35 mmHg guided by Capnogram. Anaesthesia will be maintained with Isoflurane 1,5 to 2 vol%. Patient will be given 50% oxygen/air mixture, and Incremental doses of fentanyl (0.5µg/kg) will be given every 1 hour. The depth of anaesthesia will be adjusted to keep changes of hemodynamics; (MAP) and (HR); within the range of ±20% of the baseline.
Under complete aseptic conditions, The blocks will be performed by a consultant anesthesiologist with a 5-year of experience in regional nerve blocks.
The blocks will be performed with a 20gauge, echogenic needle (Pajunk, 120mm, Germany).
The patients will be randomly divided into two groups,then the desired block will be done.
Surgical procedure will be started after performing the desired block.
At the end of surgery, Patients will be extubated after reversal of muscle relaxant by neostigmine 0.05 mg/kg with atropine 0.02 mg/kg. Patients will be transported to Post Anaesthesia care unit (PACU). HR, systolic, diastolic and mean pressures will be observed.
- Conditions
- Postoperative Pain
- Being tested
- Bilateral Modified Pectoral Nerve Block (PECS II)., Bilateral Thoracic Erector spinae plane block (ESPB).
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Modified Pectoral Nerve Block (PECS II).Procedure or surgery
The procedure will be done bilateral with the patient lying in the supine position and the ipsilateral arm will be abducted and externally rotated, and the elbow flexed 90°.
The block will be managed by in-plane technique. After confirming the location of the needle with 2-3 mL of saline, 10 mL of 0.25% bupivacaine will be injected. Then, the needle will be advanced to the interfascial plane between the pectoralis minor and serratus anterior muscle, and 20 mL of 0.25% bupivacaine will be administered with the same procedure. The Block will be repeated on the other side using similar technique taking into consideration the toxic dose of bupivacaine
Bilateral Thoracic Erector spinae plane block (ESPB).Procedure or surgery
Under all aseptic precautions and sonar guided, ESP block will be managed at T4 or T5 bilateral using a high-frequency linear ultrasound probeWe will inject 20ml of bupivacaine 0.25% into interfacial plane below to erector spinae, a manifest linear pattern will be visualized uplifting the muscle. The Block will be repeated on the other side using similar technique taking into consideration the toxic dose of bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| PECS II group | Experimental | PECS II group will receive Bilateral Modified Pectoral Nerve Block (PECS II) Group Under all aseptic precautions and sonar guided.
10 mL of 0.25% bupivacaine will be injected. Then, the needle will be advanced to the interfascial plane between the pectoralis minor and serratus anterior muscle, and 20 mL of 0.25% bupivacaine will be administered with the same procedure. The Block will be repeated on the other side using similar technique taking into consideration the toxic dose of bupivacaine. Receives: Procedure: Bilateral Modified Pectoral Nerve Block (PECS II). |
| ESP group | Experimental | ESP group will receive Bilateral Thoracic Erector spinae plane block (ESPB) Group.
Under all aseptic precautions and sonar guided. We will inject 20ml of bupivacaine 0.25% into interfacial plane below to erector spinae, a manifest linear pattern will be visualized uplifting the muscle. The Block will be repeated on the other side using similar technique taking into consideration the toxic dose of bupivacaine Receives: Procedure: Bilateral Thoracic Erector spinae plane block (ESPB). |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time interval from end of the block technique to first supplemental dose of analgesia in hours.
Postoperative pain will be evaluated by Numeric Rating Scale for pain (NRS Pain) which is a 11 point scale divided as 0=no pain,1-3(mild pain), 4-7(moderate pain) and 7-10(severe pain), 0-10 scale will be recorded by the main investigator at PACU, 2, 4, 8, 12,18 and 24 hours postoperatively.
First rescue analgesia will be given with Injection Morphine sulfate (0.1mg/kg) IV when numerical rating scale score is equal to or more than 4. If the patient requires second dose of rescue analgesia only half of the original dose of morphine is given taking into consideration the adverse effect of morphine
Measured: 24 hours
Secondary outcomes (1)
Total morphine doses in mg.
Total morphine consumption in 24 hours postoperative will be calculated
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start1 Mar 2024
- Primary completion1 Sep 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yasmeen Mohamed, Principal investigator, Ainshams university, faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478654
- Sponsor's protocol ID
- FMASU MS77/2024
- Status last verified
- Feb 2024
- First submitted
- 23 Jun 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be shared once study is completed
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Bilateral Modified Pectoral Nerve (PECS II) Block Vs Bilateral Thoracic Erector Spinae Plane (ESP) Block for Postoperative Analgesia for Aesthetic Breast Surgeries
- ClinicalTrials.gov ID
- NCT06478654
- Acronym / sponsor ID
- FMASU MS77/2024
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 27 Jun 2024 (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 Effectiveness of Ultrasound Guided Modified Pectoral Nerve Block (PECS II) versus Thoracic Erector Spinae Plane Block (ESPB) for postoperative Analgesia in cases of aesthetic breast surgeries.
Detailed description
Preoperative settings:
All the patients will be fasting for solid food for at least 6 hours and for clear fluids for 4 hours before surgery and will be instructed about Numeric Rating Scale (NRS) and its interpretation.
Intravenous access will be inserted, premedication with midazolam 3 mg will be done. On arrival to operating room, routine monitoring including electrocardiography (ECG), non-invasive arterial blood pressure(NIBP) and pulse oximetry will be used. The mean arterial blood pressure (MAP)and heart rate (HR) will be recorded before induction of general anaesthesia (baseline).
Intraoperative \& postoperative settings :
A prophylactic antibiotic will be given after skin sensetivity test then General Intravenous anaesthesia induction will be done. Patient inductions by Propofol (2 mg/kg), Atracurium 0.5 mg/kg and Fentanyl 1 µg/kg. Endotracheal intubation will be settled then Patients will be mechanically ventilated and ventilator parameters will be set to keep end tidal CO2 between 30-35 mmHg guided by Capnogram. Anaesthesia will be maintained with Isoflurane 1,5 to 2 vol%. Patient will be given 50% oxygen/air mixture, and Incremental doses of fentanyl (0.5µg/kg) will be given every 1 hour. The depth of anaesthesia will be adjusted to keep changes of hemodynamics; (MAP) and (HR); within the range of ±20% of the baseline.
Under complete aseptic conditions, The blocks will be performed by a consultant anesthesiologist with a 5-year of experience in regional nerve blocks.
The blocks will be performed with a 20gauge, echogenic needle (Pajunk, 120mm, Germany).
The patients will be randomly divided into two groups,then the desired block will be done.
Surgical procedure will be started after performing the desired block.
At the end of surgery, Patients will be extubated after reversal of muscle relaxant by neostigmine 0.05 mg/kg with atropine 0.02 mg/kg. Patients will be transported to Post Anaesthesia care unit (PACU). HR, systolic, diastolic and mean pressures will be observed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PECS II group | Experimental | Procedure: Bilateral Modified Pectoral Nerve Block (PECS II).PECS II group will receive Bilateral Modified Pectoral Nerve Block (PECS II) Group Under all aseptic precautions and sonar guided. 10 mL of 0.25% bupivacaine will be injected. Then, the needle will be advanced to the interfascial plane between the pectoralis minor and serratus anterior muscle, and 20 mL of 0.25% bupivacaine will be administered with the same procedure. The Block will be repeated on the other side using similar technique taking into consideration the toxic dose of bupivacaine. |
| ESP group | Experimental | Procedure: Bilateral Thoracic Erector spinae plane block (ESPB).ESP group will receive Bilateral Thoracic Erector spinae plane block (ESPB) Group. Under all aseptic precautions and sonar guided. We will inject 20ml of bupivacaine 0.25% into interfacial plane below to erector spinae, a manifest linear pattern will be visualized uplifting the muscle. The Block will be repeated on the other side using similar technique taking into consideration the toxic dose of bupivacaine |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Females aged ≥21 years' old.
- BMI ≤35.
- Patients with ASA I \& II.
- Scheduled for one of the aesthetic breast surgeries.
Key exclusion criteria (6 listed)
- Patients refusal.
- Contraindications to regional anaesthesia as bleeding disorders, spine deformity and local infection.
- Patients with unstable cardiovascular disease.
- Emergency surgery.
- Patients with chronic pain.
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 |
|---|---|---|
| Bilateral Modified Pectoral Nerve Block (PECS II).The procedure will be done bilateral with the patient lying in the supine position and the ipsilateral arm will be abducted and externally rotated, and the elbow flexed 90°. The block will be managed by in-plane technique. After confirming the location of the needle with 2-3 mL of saline, 10 mL of 0.25% bupivacaine will be injected. Then, the needle will be advanced to the interfascial plane between the pectoralis minor and serratus anterior muscle, and 20 mL of 0.25% bupivacaine will be administered with the same procedure. The Block will be repeated on the other side using similar technique taking into consideration the toxic dose of bupivacaine | Procedure or surgery | PECS II group |
| Bilateral Thoracic Erector spinae plane block (ESPB).Under all aseptic precautions and sonar guided, ESP block will be managed at T4 or T5 bilateral using a high-frequency linear ultrasound probeWe will inject 20ml of bupivacaine 0.25% into interfacial plane below to erector spinae, a manifest linear pattern will be visualized uplifting the muscle. The Block will be repeated on the other side using similar technique taking into consideration the toxic dose of bupivacaine. | Procedure or surgery | ESP group |
Primary outcome
the time interval from end of the block technique to first supplemental dose of analgesia in hours.
Time frame: 24 hours
Postoperative pain will be evaluated by Numeric Rating Scale for pain (NRS Pain) which is a 11 point scale divided as 0=no pain,1-3(mild pain), 4-7(moderate pain) and 7-10(severe pain), 0-10 scale will be recorded by the main investigator at PACU, 2, 4, 8, 12,18 and 24 hours postoperatively. First rescue analgesia will be given with Injection Morphine sulfate (0.1mg/kg) IV when numerical rating scale score is equal to or more than 4. If the patient requires second dose of rescue analgesia only half of the original dose of morphine is given taking into consideration the adverse effect of morphine
1 secondary outcome
Total morphine doses in mg.
Time frame: 24 hours
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 3 Dec 2024.
- Individual participant dataSharing planned: Yes. All data will be shared once study is completed
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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.
Yasmeen Mohamed principal investigator
Ainshams university, faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral Modified Pectoral Nerve Block (PECS II). and Bilateral Thoracic Erector spinae plane block (ESPB). in people with Postoperative Pain, run by Ain Shams 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 3 Dec 2024. 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 time interval from end of the block technique to first supplemental dose of analgesia in hours. (time frame: 24 hours). 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 3 Dec 2024.