MastectomyNCT05156775
The Efficacy of Ultrasound-Guided Rhomboid Intercostal Block Versus Serratus Plane Block in Mastectomy.
A study testing Serratus Plane Block (SPB) and Rhomboid intercostal nerve block (RIB) in people with Mastectomy and Rhomboid Intercostal Block, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate analgesic efficacy of ultrasound-guided rhomboid plane block or serratus plane block versus Intravenous opioid in patients undergoing modified radical mastectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Mastectomy, Rhomboid Intercostal Block, Serratus Plane Block
- What is being tested?
- Serratus Plane Block (SPB) and Rhomboid intercostal nerve block (RIB)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 29 May 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients
- Scheduled for unilateral modified radical mastectomy.
- Age 18-65 years
- American Society of Anesthesiologists (ASA) physical status I- II
Who cannot join
- Patient refusal
- Coagulation disorders
- Body mass index > 35 kg/m2
- Uncooperative or psychiatric patients
- Infection at the injection site
- Patients with a history of allergy to local anesthetics
- Patients with a history of treatment for chronic pain
- Previous history of breast surgery or other chest surgery
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospital
Tanta, Elgharbia, 31511
Dina H Alhassanin, 00201143441294, dina154456@med.tanta.edu.eg
About this study
Official title: The Efficacy of Ultrasound-Guided Rhomboid Intercostal Block Versus Serratus Plane Block in Patients Undergoing Modified Radical Mastectomy: A Prospective Randomized Controlled Study.
The aim of this study is to evaluate analgesic efficacy of ultrasound-guided rhomboid plane block or serratus plane block versus Intravenous opioid in patients undergoing modified radical mastectomy.
Read the detailed description
Breast cancer is the most frequently diagnosed malignancy and is the leading cause of cancer-related death among the female population.
Modified radical mastectomy (MRM) is the standard surgical treatment for cancer breast, which is usually associated with moderate to severe acute postoperative pain. Adequate postoperative pain relief is important to improve functional outcomes and to accelerate recovery and decrease hospital stay.
The postoperative pain may last >3 to 6 months after surgery and may proceed to chronic pain, with an incidence of 20% to 30%. Because chronic pain has many negative effects on patients, it may decrease the overall quality of life and may be a potential source of chronic opioid use. Therefore, preventing chronic pain is essential in these patients. In this regard, good acute postoperative pain management strategies have a very important role.
Regional anesthesia techniques can provide good postoperative pain management and may cause less incidence of chronic pain.
Many analgesic techniques have been proposed to relieve acute postoperative pain, including intercostal block, local anesthetic (LA) infiltration, block, paravertebral block, serratus plane block (SPB), and rhomboid intercostal block (RIB) to relieve acute postoperative pain
- Conditions
- Mastectomy, Rhomboid Intercostal Block, Serratus Plane Block
- Being tested
- Serratus Plane Block (SPB), Rhomboid intercostal nerve block (RIB)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus Plane Block (SPB)Other
While the patient is in the supine position, the arm will be abducted, the ultrasound probe will be placed over the mid-clavicular region of the thoracic cage in sagittal plane. Ribs will be counted until the fifth rib will be identified in the midaxillary line. the latissimus dorsi (superficial and posterior ), teres major (superior), and serratus muscle (deep and inferior)will be identified overlying the fifth rib. As an extra reference point, thoracodorsal artery will be used, this aids in the identification of the plane superficial to the serratus muscle, 30 ml 0.25 %bupivacaine will be injected between latissimus dorsi and serratus anterior muscles at the level of the 5th rib in the mid axillary line.
Rhomboid intercostal nerve block (RIB)Other
In the rhomboid intercostal nerve block (RIB) group, the patient will be placed in a lateral position with the affected breast at the top. The ipsilateral arm will be extended to the same level as the ipsilateral chest and breast, and the scapula will be moved outward. On the oblique sagittal plane, a high frequency (6-12MHz) linear ultrasound probe will be placed on the medial edge of the scapula. The US landmarks, trapezius muscle, rhomboid muscle, intercostal muscles, pleura, and lung will be identified. Under the aseptic condition, a 22-gauge needle will be inserted in the plan to the US probe at T5 to T6 levels. Then, 0.25% bupivacaine (30 mL) will be injected into the inter-fascial plane between the rhomboid major muscle and the intercostal muscle, the diffusion of bupivacaine in the fascia between the rhomboid muscle and the intercostal muscle will be visualized. Then, the patient will be positioned in supine position.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous analgesia group | No intervention | 35 Patients will receive intravenous morphine (mg) analgesia only. |
| Serratus Plane Block (SPB) group | Experimental | 35 Patients will receive ipsilateral serratus plane block using 30 ml bupivacaine 0.25% at the level of the 5th rib. Receives: Other: Serratus Plane Block (SPB) |
| Rhomboid intercostal nerve block (RIB) group | Experimental | 35 Patients will receive ipsilateral rhomboid intercostal nerve block using 30 ml bupivacaine 0.25%. Receives: Other: Rhomboid intercostal nerve block (RIB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total rescue morphine (mg) consumption in the first 24 post-operative hours.
Rescue analgesia in the form of 3 mg intravenous morphine (mg) will be given if the visual analog scale is ≥ 4 repeated with 10 minutes lockout interval till the visual analog scale becomes less than 3 guided with the occurrence of complications as nausea, vomiting, and respiratory depression.
Measured: 24 hours postoperative
Secondary outcomes (6)
Post-operative pain assessed by visual analog scale (VAS)
Postoperative pain will be assessed using a visual analog scale after 15 minutes after admission to the Post-anesthesia care unit and, 2, 4, 6, 8, 12,16, and 24 hours postoperatively.
VAS ranged from 0 to 10 (the lowest is less pain)
Measured: 24 hours Postoperative
Heart rate
Heart rate (beats/min) will be recorded at baseline before induction, after induction, and before skin incision then every 15 minutes till the end of the operation
Measured: Intraoperative
Mean arterial blood pressure
Mean arterial blood pressure will be recorded at baseline before induction, after induction, and before skin incision then every 15 minutes till the end of the operation
Measured: Intraoperative
Time to first rescue analgesic request (minutes)
Time to the first rescue analgesic request (minutes) will be also recorded. Rescue analgesia in the form of 3 mg intravenous morphine (mg) will be given if the visual analog scale is ≥ 4
Measured: 24 hours Postoperative
Intraoperative fentanyl consumption (µg).
Inadequate analgesia in the form of increase of heart rate or mean arterial blood pressure ≥ 20% above the baseline will be managed using 1µg/ kg of IV fentanyl. The total intravenous fentanyl consumption will be recorded at the end of the operation
Measured: Intraoperative
Adverse effects
Any intraoperative or postoperative complications such as nausea, vomiting, hematoma, hypotension (defined as any decrease in mean arterial blood pressure of >20% of the preoperative baseline value), Bradycardia (defined as a decrease in heart rate < 50 beat/min), or pneumothorax will be recorded. Bradycardia will be treated by atropine intravenous injection (0.01 mg/kg) which may be repeated if needed. Hypotension will be treated by250 ml intravenous saline, and a bolus dose of intravenous Ephedrine 5 mg, which may be repeated if no response.
Measured: intraoperative or 24 hours Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start1 Jan 2022
- Primary completion29 May 2022 (estimated)
- Study completion29 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastectomyStudies 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, Investigator
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Hamdy Alhassanin, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156775
- Sponsor's protocol ID
- 34981/10/21
- Status last verified
- Feb 2022
- First submitted
- 27 Nov 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The supporting data will be available upon a reasonable request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Ultrasound-Guided Rhomboid Intercostal Block Versus Serratus Plane Block in Patients Undergoing Modified Radical Mastectomy: A Prospective Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT05156775
- Acronym / sponsor ID
- 34981/10/21
- Conditions
- Mastectomy, Rhomboid Intercostal Block, Serratus Plane Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 29 May 2022 (estimated)
- Study completion
- 29 May 2022 (estimated)
- First posted
- 14 Dec 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 analgesic efficacy of ultrasound-guided rhomboid plane block or serratus plane block versus Intravenous opioid in patients undergoing modified radical mastectomy.
Detailed description
Breast cancer is the most frequently diagnosed malignancy and is the leading cause of cancer-related death among the female population.
Modified radical mastectomy (MRM) is the standard surgical treatment for cancer breast, which is usually associated with moderate to severe acute postoperative pain. Adequate postoperative pain relief is important to improve functional outcomes and to accelerate recovery and decrease hospital stay.
The postoperative pain may last >3 to 6 months after surgery and may proceed to chronic pain, with an incidence of 20% to 30%. Because chronic pain has many negative effects on patients, it may decrease the overall quality of life and may be a potential source of chronic opioid use. Therefore, preventing chronic pain is essential in these patients. In this regard, good acute postoperative pain management strategies have a very important role.
Regional anesthesia techniques can provide good postoperative pain management and may cause less incidence of chronic pain.
Many analgesic techniques have been proposed to relieve acute postoperative pain, including intercostal block, local anesthetic (LA) infiltration, block, paravertebral block, serratus plane block (SPB), and rhomboid intercostal block (RIB) to relieve acute postoperative pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intravenous analgesia group | No intervention | –35 Patients will receive intravenous morphine (mg) analgesia only. |
| Serratus Plane Block (SPB) group | Experimental | Other: Serratus Plane Block (SPB)35 Patients will receive ipsilateral serratus plane block using 30 ml bupivacaine 0.25% at the level of the 5th rib. |
| Rhomboid intercostal nerve block (RIB) group | Experimental | Other: Rhomboid intercostal nerve block (RIB)35 Patients will receive ipsilateral rhomboid intercostal nerve block using 30 ml bupivacaine 0.25%. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients
- Scheduled for unilateral modified radical mastectomy.
- Age 18-65 years
- American Society of Anesthesiologists (ASA) physical status I- II
Key exclusion criteria (8 listed)
- Patient refusal
- Coagulation disorders
- 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 |
|---|---|---|
| Serratus Plane Block (SPB)While the patient is in the supine position, the arm will be abducted, the ultrasound probe will be placed over the mid-clavicular region of the thoracic cage in sagittal plane. Ribs will be counted until the fifth rib will be identified in the midaxillary line. the latissimus dorsi (superficial and posterior ), teres major (superior), and serratus muscle (deep and inferior)will be identified overlying the fifth rib. As an extra reference point, thoracodorsal artery will be used, this aids in the identification of the plane superficial to the serratus muscle, 30 ml 0.25 %bupivacaine will be injected between latissimus dorsi and serratus anterior muscles at the level of the 5th rib in the mid axillary line. | Other | Serratus Plane Block (SPB) group |
| Rhomboid intercostal nerve block (RIB)In the rhomboid intercostal nerve block (RIB) group, the patient will be placed in a lateral position with the affected breast at the top. The ipsilateral arm will be extended to the same level as the ipsilateral chest and breast, and the scapula will be moved outward. On the oblique sagittal plane, a high frequency (6-12MHz) linear ultrasound probe will be placed on the medial edge of the scapula. The US landmarks, trapezius muscle, rhomboid muscle, intercostal muscles, pleura, and lung will be identified. Under the aseptic condition, a 22-gauge needle will be inserted in the plan to the US probe at T5 to T6 levels. Then, 0.25% bupivacaine (30 mL) will be injected into the inter-fascial plane between the rhomboid major muscle and the intercostal muscle, the diffusion of bupivacaine in the fascia between the rhomboid muscle and the intercostal muscle will be visualized. Then, the patient will be positioned in supine position. | Other | Rhomboid intercostal nerve block (RIB) group |
Primary outcome
The total rescue morphine (mg) consumption in the first 24 post-operative hours.
Time frame: 24 hours postoperative
Rescue analgesia in the form of 3 mg intravenous morphine (mg) will be given if the visual analog scale is ≥ 4 repeated with 10 minutes lockout interval till the visual analog scale becomes less than 3 guided with the occurrence of complications as nausea, vomiting, and respiratory depression.
6 secondary outcomes
Post-operative pain assessed by visual analog scale (VAS)
Time frame: 24 hours Postoperative
Heart rate
Time frame: Intraoperative
Mean arterial blood pressure
Time frame: Intraoperative
Time to first rescue analgesic request (minutes)
Time frame: 24 hours Postoperative
Intraoperative fentanyl consumption (µg).
Time frame: Intraoperative
Adverse effects
Time frame: intraoperative or 24 hours Postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: Yes. The supporting data will be available upon a reasonable request from the corresponding author
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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.
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 Plane Block (SPB) and Rhomboid intercostal nerve block (RIB) in people with Mastectomy and Rhomboid Intercostal Block, 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 8 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 2 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dina H. Alhassanin, M.B.B.CH (1143441294 ext. +20, dina154456@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total rescue morphine (mg) consumption in the first 24 post-operative hours. (time frame: 24 hours postoperative). 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 2 Mar 2022.