U/S Guided SAB VS U/S Guided SAB Combined With Modified Pectoral Nerve BlockNCT05006612
U/S Guided SAB VS U/S Guided SAB With Modified Pectoral Nerve Block in Modified Radical Mastectomy
A study testing Serratus Anterior Plane Block in people with U/S Guided SAB VS U/S Guided SAB Combined With Modified Pectoral Nerve Block, run by Cairo University at 1 site in Egypt.
Trial summary
We hypothesize that ultrasound guided serratus anterior plane block Combined With Modified Pectoral Nerve Block is going to be more effective than Ultrasound guided Serratus anterior plane block alone in patients undergoing MRM as modified Pecs block involves the block of medial and lateral pectoral nerves which are… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- U/S Guided SAB VS U/S Guided SAB Combined With Modified Pectoral Nerve Block
- What is being tested?
- Serratus Anterior Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jun 2021to 23 Aug 2021
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female patients
- Type of surgery; Modified Radical Mastectomy (MRM)
- Physical status ASA I, II, III.
- Age ≥ 18 and ≤ 65 Years.
- Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.
Who cannot join
- Age <18 years or >65 years
- BMI <20 kg/m2 and >35 kg/m2
- Known sensitivity or contraindication to drug used in the study (local anaesthetics, opioids).
- History of psychological disorders and/or chronic pain.
- Contraindication to regional anaesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
- Patient refusal.
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- Severe respiratory or cardiac disorders.
- Advanced liver or kidney disease.
- Pregnancy.
- Physical status ASA IV and Male patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: U/S Guided SAB VS U/S Guided SAB With Modified Pectoral Nerve Block in Modified Radical Mastectomy,Randomized Double Blinded Comparative Study
We hypothesize that ultrasound guided serratus anterior plane block Combined With Modified Pectoral Nerve Block is going to be more effective than Ultrasound guided Serratus anterior plane block alone in patients undergoing MRM as modified Pecs block involves the block of medial and lateral pectoral nerves which are spared in case of serratus block alone, resulting in reducing myofascial pain and opioid consumption.
Read the detailed description
Ultrasound guided Serratus anterior plane block was introduced in 2013 for analgesia of breast and lateral thoracic wall surgery. At the axillary fossa, the intercostobrachialis nerve, lateral cutaneous branches of the intercostal nerves (T3-T9), long thoracic nerve, and thoracodorsal nerve are located in a compartment between the serratus anterior and the latissimus dorsi muscles, between the posterior and midaxillary lines at this plane local anesthetic will be injected . Complications of serratus anterior plane block include local anesthetic toxicity and pneumothorax , unfortunately medial and lateral pectoral nerves are preserved which are responsible for the myofacial pain .
The pectoral nerves (Pecs) block types I and II (Modified Pectoral block) , is less invasive technique described by Blanco et al where local anesthetic is deposited into the plane between the pectoralis major muscle(PMm) and the pectoralis minor muscle (Pmm) (Pecs I block)and above the serratus anterior muscle at the third rib (Pecs IIblock).,Blocking intercostobrachial, third to sixth intercostals the long thoracic nerves in addition to medial and lateral pectoral nerves.
Addition of Modified Pecs block to Serratus anterior plane block will enhance the control of pain as it block the medial and lateral pectoral nerves which are responsible for the myofacial pain and which are spared in case of Serratus block alone .
- Being tested
- Serratus Anterior Plane Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus Anterior Plane BlockProcedure or surgery
Also called Serratus Anterior Plane Block SAPB combined with Modified Pectoral Nerve Block
SAPB Technique; U/S probe will be placed on the patient's midaxillary line in the transverse plane, at the level of the fifth rib, Then, using U/S guidance, A 38-mm 22-gauge regional block needle is advanced in-plane at an angle of approximately 45 degrees towards the fifth rib. After aspiration to avoid IV injection 30ml of levobupivacaine 0.25% is injected anteriorly to the rib and deep to the serratus anterior muscle.
SAPB combined with Modified Pectoral Nerve Block :
SAPB with injection of 20 ml levobupivacaine 0.25% as discussed before. Modified Pectoral Nerve Block:After identification of the axillary vessels, the U/S probe will turned inferolaterally till the serratus anterior and the two pectoralis muscles are detected in one plane. 10 ml of levobupivacaine 0.25%was injected between the two pectoralis muscles. After that,10 mL of levobupivacaine 0.25%is injected above this muscle.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 ((Serratus Anterior Plane Block SAPB) | Active comparator | N=3o Patients will receive Ultrasound guided Serratus Anterior Plane Block with injection of 30 ml levobupivacaine 0.25%. Receives: Procedure: Serratus Anterior Plane Block |
| Group 2 ((Serratus Anterior Plane Block SAPB combined with Modified Pectoral Nerve Block) | Active comparator | N=3o Patients will receive Ultrasound guided Serratus Anterior Plane Block with injection of 20 ml levobupivacaine 0.25%and Modified Pectoral Nerve Block with injection of 10 ml levobupivacaine 0.25%between the two pectoralis muscles, after that, the probe was turned toward the axilla, and as the serratus anterior muscle was recognized above the third and fourth ribs, 10 mL of levobupivacaine 0.25% was injected above this muscle Receives: Procedure: Serratus Anterior Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total amount of morphine consumption in the first 24 hours postoperatively
The total amount of morphine consumption in the first 24 hours postoperatively
Measured: Through Study Completion
Secondary outcomes (9)
Total amount of intraoperative fentanyl will be recorded.
Total amount of intraoperative fentanyl will be recorded.
Measured: Through Study Completion over the first 24 hrs postoperative
Change in heart rate and mean arterial blood pressure intraoperatively at 30 minutes interval in comparison to baseline reading.
Change in heart rate and mean arterial blood pressure intraoperatively at 30 minutes interval in comparison to baseline reading.
Measured: Through Study Completion over the first 24 hrs postoperative
The degree of postoperative sedation according to Ramsay scores
postoperative sedation according to Ramsay scores
Measured: Through Study Completion over the first 24 hrs postoperative .
Heart rate, mean arterial blood pressure and VAS (at rest and during movement) at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.
Change in hemodynamics ((heart rate and mean arterial blood pressure)
Measured: Through Study Completion over the first 24 hrs postoperative
Postoperative nausea and vomiting (PONV) as side effects of morphine.
Nausea and vomiting Scores using a four-point verbal scale:
Measured: Through Study Completion over the first 24 hrs postoperative
Time of first rescue analgesia
Time of first rescue analgesia
Measured: Through Study Completion over the first 24 hrs postoperative
Complications related to blocks such as local anaesthetic systemic toxicity, pneumothorax and arterial puncture (US check postoperative).
Complications related to blocks such as local anaesthetic systemic toxicity, pneumothorax and arterial puncture
Measured: Through Study Completion over the first 24 hrs postoperative
Morphine related complications such as respiratory depression, urine retention or pruritis
Morphine related complications such as respiratory depression, urine retention or pruritis
Measured: Through Study Completion over the first 24 hrs postoperative
Patient satisfaction the patient will be classified in this group to satisfied or not.
Patient satisfaction the patient will be classified in this group to satisfied or not.
Measured: Through Study Completion over the first 24 hrs postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start14 Jun 2021
- Primary completion16 Aug 2021
- Study completion23 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for U/S Guided SAB VS U/S Guided SAB Combined With Modified Pectoral Nerve BlockStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To determine the analgesic effect of ultrasound guided Serratus anterior block combined with modified pectoral nerve block compared to ultrasound guided Serratus Anterior block in patients undergoing modified radical mastectomy regarding the following : 1-Post-operative opioid (morphine) consumption in the 1st 24 hours 2- Post-operative Numeric Pain Rating Scale. 3\. Effect on hemodynamics: Mean arterial blood pressure and Heart rate. 4\. Intraoperative fentanyl consumption. 5\. Duration of analgesic effect
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Samuel Bekhet Moawad, Ahmed Shaker Ragab, Michael Wahib Wadid
- Responsible party
- Principal investigator, Ahmed Abdalla, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006612
- Sponsor's protocol ID
- MS-201-2021
- Status last verified
- Jul 2022
- First submitted
- 21 Jul 2021
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Till publication
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- U/S Guided SAB VS U/S Guided SAB With Modified Pectoral Nerve Block in Modified Radical Mastectomy,Randomized Double Blinded Comparative Study
- ClinicalTrials.gov ID
- NCT05006612
- Acronym / sponsor ID
- MS-201-2021
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Samuel Bekhet Moawad, Ahmed Shaker Ragab, Michael Wahib Wadid
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 16 Aug 2021 (actual)
- Study completion
- 23 Aug 2021 (actual)
- First posted
- 16 Aug 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.
We hypothesize that ultrasound guided serratus anterior plane block Combined With Modified Pectoral Nerve Block is going to be more effective than Ultrasound guided Serratus anterior plane block alone in patients undergoing MRM as modified Pecs block involves the block of medial and lateral pectoral nerves which are spared in case of serratus block alone, resulting in reducing myofascial pain and opioid consumption.
Detailed description
Ultrasound guided Serratus anterior plane block was introduced in 2013 for analgesia of breast and lateral thoracic wall surgery. At the axillary fossa, the intercostobrachialis nerve, lateral cutaneous branches of the intercostal nerves (T3-T9), long thoracic nerve, and thoracodorsal nerve are located in a compartment between the serratus anterior and the latissimus dorsi muscles, between the posterior and midaxillary lines at this plane local anesthetic will be injected . Complications of serratus anterior plane block include local anesthetic toxicity and pneumothorax , unfortunately medial and lateral pectoral nerves are preserved which are responsible for the myofacial pain .
The pectoral nerves (Pecs) block types I and II (Modified Pectoral block) , is less invasive technique described by Blanco et al where local anesthetic is deposited into the plane between the pectoralis major muscle(PMm) and the pectoralis minor muscle (Pmm) (Pecs I block)and above the serratus anterior muscle at the third rib (Pecs IIblock).,Blocking intercostobrachial, third to sixth intercostals the long thoracic nerves in addition to medial and lateral pectoral nerves.
Addition of Modified Pecs block to Serratus anterior plane block will enhance the control of pain as it block the medial and lateral pectoral nerves which are responsible for the myofacial pain and which are spared in case of Serratus block alone .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- To determine the analgesic effect of ultrasound guided Serratus anterior block combined with modified pectoral nerve block compared to ultrasound guided Serratus Anterior block in patients undergoing modified radical mastectomy regarding the following : 1-Post-operative opioid (morphine) consumption in the 1st 24 hours 2- Post-operative Numeric Pain Rating Scale. 3. Effect on hemodynamics: Mean arterial blood pressure and Heart rate. 4. Intraoperative fentanyl consumption. 5. Duration of analgesic effect
| Arm | Type | Receives |
|---|---|---|
| Group 1 ((Serratus Anterior Plane Block SAPB) | Active comparator | Procedure: Serratus Anterior Plane BlockN=3o Patients will receive Ultrasound guided Serratus Anterior Plane Block with injection of 30 ml levobupivacaine 0.25%. |
| Group 2 ((Serratus Anterior Plane Block SAPB combined with Modified Pectoral Nerve Block) | Active comparator | Procedure: Serratus Anterior Plane BlockN=3o Patients will receive Ultrasound guided Serratus Anterior Plane Block with injection of 20 ml levobupivacaine 0.25%and Modified Pectoral Nerve Block with injection of 10 ml levobupivacaine 0.25%between the two pectoralis muscles, after that, the probe was turned toward the axilla, and as the serratus anterior muscle was recognized above the third and fourth ribs, 10 mL of levobupivacaine 0.25% was injected above this muscle |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female patients
- Type of surgery; Modified Radical Mastectomy (MRM)
- Physical status ASA I, II, III.
- Age ≥ 18 and ≤ 65 Years.
- Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.
Key exclusion criteria (10 listed)
- Age <18 years or >65 years
- BMI <20 kg/m2 and >35 kg/m2
- Known sensitivity or contraindication to drug used in the study (local anaesthetics, opioids).
- History of psychological disorders and/or chronic pain.
- Contraindication to regional anaesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
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 |
|---|---|---|
| Serratus Anterior Plane BlockAlso: Serratus Anterior Plane Block SAPB combined with Modified Pectoral Nerve BlockSAPB Technique; U/S probe will be placed on the patient's midaxillary line in the transverse plane, at the level of the fifth rib, Then, using U/S guidance, A 38-mm 22-gauge regional block needle is advanced in-plane at an angle of approximately 45 degrees towards the fifth rib. After aspiration to avoid IV injection 30ml of levobupivacaine 0.25% is injected anteriorly to the rib and deep to the serratus anterior muscle. SAPB combined with Modified Pectoral Nerve Block : SAPB with injection of 20 ml levobupivacaine 0.25% as discussed before. Modified Pectoral Nerve Block:After identification of the axillary vessels, the U/S probe will turned inferolaterally till the serratus anterior and the two pectoralis muscles are detected in one plane. 10 ml of levobupivacaine 0.25%was injected between the two pectoralis muscles. After that,10 mL of levobupivacaine 0.25%is injected above this muscle. | Procedure or surgery | Group 1 ((Serratus Anterior Plane Block SAPB), Group 2 ((Serratus Anterior Plane Block SAPB combined with Modified Pectoral Nerve Block) |
Primary outcome
The total amount of morphine consumption in the first 24 hours postoperatively
Time frame: Through Study Completion
The total amount of morphine consumption in the first 24 hours postoperatively
9 secondary outcomes
Total amount of intraoperative fentanyl will be recorded.
Time frame: Through Study Completion over the first 24 hrs postoperative
Change in heart rate and mean arterial blood pressure intraoperatively at 30 minutes interval in comparison to baseline reading.
Time frame: Through Study Completion over the first 24 hrs postoperative
The degree of postoperative sedation according to Ramsay scores
Time frame: Through Study Completion over the first 24 hrs postoperative .
Heart rate, mean arterial blood pressure and VAS (at rest and during movement) at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.
Time frame: Through Study Completion over the first 24 hrs postoperative
Postoperative nausea and vomiting (PONV) as side effects of morphine.
Time frame: Through Study Completion over the first 24 hrs postoperative
Time of first rescue analgesia
Time frame: Through Study Completion over the first 24 hrs postoperative
Complications related to blocks such as local anaesthetic systemic toxicity, pneumothorax and arterial puncture (US check postoperative).
Time frame: Through Study Completion over the first 24 hrs postoperative
Morphine related complications such as respiratory depression, urine retention or pruritis
Time frame: Through Study Completion over the first 24 hrs postoperative
Patient satisfaction the patient will be classified in this group to satisfied or not.
Time frame: Through Study Completion over the first 24 hrs postoperative
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 19 Jul 2022.
- Individual participant dataSharing planned: Undecided. Till publication
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 Serratus Anterior Plane Block in people with U/S Guided SAB VS U/S Guided SAB Combined With Modified Pectoral Nerve Block, run by Cairo 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 5 inclusion and 10 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 19 Jul 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 of morphine consumption in the first 24 hours postoperatively (time frame: Through Study Completion). 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 19 Jul 2022; AzTrials last refreshed its copy on 30 Oct 2026.