Breast Neoplasm FemaleNCT06274814
U/S Guided Rhomboid Intercostal Block Combined With Sub-Serratus Plane Block vs Type 2 Pectoral Nerve Block
A study testing U/S guided Type 2 Pectoral Nerve Block and U/S guided RIB combined with the sub-serratus plane block (RISS) in people with Breast Neoplasm Female and Analgesics, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
The aim of this study is to compare between U/S Guided Rhomboid Intercostal Block Combined with Sub-Serratus Plane Block vs type 2 Pectoral Nerve Block in Analgesia for Breast Cancer Surgery by measuring intraoperative hemodynamics, postoperative pain scores and morphine consumption in the first 24 h postoperative. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Neoplasm Female, Analgesics
- What is being tested?
- U/S guided Type 2 Pectoral Nerve Block and U/S guided RIB combined with the sub-serratus plane block (RISS)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 May 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients.
- Scheduled for unilateral conservative mastectomy.
- Age 18-65 years.
- American Society of Anesthesiologists (ASA) physical status I- II.
Who cannot join
- Patient refusal.
- Coagulation disorders.
- Body mass index > 40 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.
About this study
Official title: Ultrasound Guided Rhomboid Intercostal Block Combined With Sub-Serratus Plane Block vs Type 2 Pectoral Nerve Block in Analgesia for Breast Cancer Surgery
The aim of this study is to compare between U/S Guided Rhomboid Intercostal Block Combined with Sub-Serratus Plane Block vs type 2 Pectoral Nerve Block in Analgesia for Breast Cancer Surgery by measuring intraoperative hemodynamics, postoperative pain scores and morphine consumption in the first 24 h postoperative.
Read the detailed description
Patients will be randomly allocated into three groups based on a computerized randomization table with specific ID for each patient (23 per group). Each patient will be prepared in Preoperative Holding Area with sedation with midazolam 0.05mg/kg patients allotted to the RIB group were positioned in the lateral decubitus position with the breast on the operating side lying superiorly. The ipsilateral arm was abducted from the chest to move the scapula laterally. The RISS was performed after application of antiseptic solution. A high-frequency using a 6-13 MHz linear ultrasound probe set to B mode (SonoSite M-turbo ultrasound machine) was placed medial to the medial border of the scapula in the oblique sagittal plane. The landmarks, i.e., the trapezius muscle, rhomboid muscle, intercostal muscles, pleura, and lung, were identified in the ultrasound. Under aseptic conditions, a 100-mm 21-gauge needle was inserted at the level of T5-6 in the ultrasound view. A single dose of 20-mL 0.25% bupivacaine was injected in the interfascial plane between the rhomboid major and intercostal muscles. The spread of the local anesthetic solution under the rhomboid muscle was visualized by ultrasonography. Thereafter, the ultrasound probe was moved caudally and laterally to identify the tissue plane between the serratus anterior and external intercostal muscles for the sub-serratus block at the T8-9 level. The needle was advanced from its previous position, and an additional 20 mL of 0.25% bupivacaine was injected. All block procedures were performed by the same anesthesiologist who had administered the RIB and RISS blocks in more than 30 cases before this study. In control group (Group C), no block intervention was performed.
After disinfection, using 30 mL of levobupivacaine 0.25% (10 mL between pectoralis minor muscle and pectoralis major muscle, and 20 mL between the pectoralis major muscle and serratus muscle). With the patient in supine position. (Group B) After shifting to the operative area, all patients underwent conventional monitoring procedures including electrocardiography, noninvasive monitoring of blood pressure, and peripheral oxygen saturation measurements. Intravenous access was gained using a 22-gauge intravenous needle, and isotonic saline was infused at a rate of 15 mL kg-1 h-1. Anesthetic management was in accordance with a standard protocol. Anesthesia was induced with pre-oxygenation for 3 min followed by intravenous injection of midazolam (0.05 mg/kg), fentanyl (0.1 µg/kg), propofol (1-2 mg/kg), and atracurium (0.5 mg/kg). An endotracheal tube was used for positive-pressure ventilation to maintain the end-tidal carbon dioxide level of 35-40 mmHg.
Anesthesia was maintained using 2% sevoflurane with 50% oxygen, fentanyl (0.1 µg kg-1 min-1), and propofol (100 µg kg-1 min-1). Additionally, atracurium (0. 1 mg/kg) was administered according to the surgical protocol. Surgery (Unilateral conservative mastectomy) was started. The anesthetic dose was adjusted to maintain blood pressure within 20% of the baseline value. An additional dose of intravenous fentanyl (0.1 µg kg-1 min-1) was injected as needed. If the blood pressure decreased by > 20% from the baseline value, 250 mL of 0.9% (physiologic) saline and ephedrine (0.1 mg/kg) were administered. If the heart rate decreased to less than 50 bpm, atropine (0.5 mg/kg) was administered. At the end of the surgery, the effect of atracurium was reversed using neostigmine and atropine as needed. After the surgery, the endotracheal tube was removed when the patient fulfills criteria of extubation. Then the patient will be transferred to the PACU.
Data will be collected:
- Intraoperative assessment: (readings will be taken just after induction and every 15 min throughout surgery)
- Heart rate intraoperative.
- Mean arterial blood pressure intraoperative.
- Analgesic consumption: recorded during intraoperative period to maintain maximum 20% change of basal vital signs after exclusion of other causes. (Intraoperative fentanyl consumption)
- Postoperative:
- Recovery time: the time taken to be fully awake and responding to commands.
- Pain score: VAS score at 0, 3, 6, 9,24h post-operative.
- Hemodynamic: pulse, B.P (systolic, diastolic, and mean blood pressure) at 0,3,6,9,24h postoperative.
- Side effects (nausea, vomiting, hematoma, hypotension, bradycardia).
- Rescue analgesia plane will be given for VAS≥4 using non-steroidal anti-inflammatory analgesic (ketorolac 30 mg) and VAS≥6 using opioid (3mg morphine). Time of the first rescue analgesia together with frequency and total dose of the given drug through the 24 hours will be recorded.
- Hospital discharge.
Primary outcome:
- Total morphine consumption in first 24 hours post operative.
- VAS score postoperative.
Secondary outcome:
- Heart rate intraoperative.
- Mean arterial blood pressure intraoperative.
- Timing of first rescue analgesia.
- Intraoperative fentanyl consumption.
- Side effects (nausea, vomiting, hematoma, hypotension, bradycardia).
- Body mass index (BMI).
- Conditions
- Breast Neoplasm Female, Analgesics
- Being tested
- U/S guided Type 2 Pectoral Nerve Block, U/S guided RIB combined with the sub-serratus plane block (RISS)
- Keywords
- Analgesics, Opioids, Breast Neoplasms, Postoperative Pain, Mastectomy, Nerve block, Breast Cancer Surgery
- Medical subject headings
- Breast Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U/S guided Type 2 Pectoral Nerve BlockProcedure or surgery
20 mL separates the pectoralis major and minor muscles, while 10 mL separates the serratus and pectoralis major muscles
U/S guided RIB combined with the sub-serratus plane block (RISS)Procedure or surgery
he ipsilateral arm was abducted. RISS was performed. Using a 6-13 MHz linear ultrasound probe was placed medial to the medial border of the scapula in the oblique sagittal plane.. A 100-mm 21-gauge needle was inserted at the level of T5-6 in the ultrasound view. A single dose of 20-mL 0.25% bupivacaine was injected in the interfascial plane between the rhomboid major and intercostal muscles. The spread of the local anesthetic solution under the rhomboid muscle was visualized by ultrasonography. Thereafter, the ultrasound probe was moved caudally and laterally to identify the tissue plane between the serratus anterior and external intercostal muscles for the sub-serratus block at the T8-9 level. The needle was advanced from its previous position, and an additional 20 mL of 0.25% bupivacaine was injected.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Pectoral Nerve Block | Active comparator | 23 patients Type 2 Pectoral Nerve Block pecs2 Group A Receives: Procedure: U/S guided Type 2 Pectoral Nerve Block |
| RISS Rhomboid intercostal block combined with the sub-serratus plane block | Active comparator | 23 patients the RIB combined with the sub-serratus plane block (RISS) Group B Receives: Procedure: U/S guided RIB combined with the sub-serratus plane block (RISS) |
| No block intervention | No intervention | routine IV analgesia 23 patients no block intervention was performed. The anesthetic dose was adjusted to maintain blood pressure within 20% of the baseline value. An additional dose of intravenous fentanyl (0.1 µg kg-1 min-1) was injected as needed. Group C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Visual Analog scale ≥6 using opioid (3mg morphine) VAS score is from 0 to 10 as 0 is no pain and 10 the wariest pain can ever experience
Measured: 24 hours
Visual Analog scale score postoperative
Visual Analog scale≥4 using non-steroidal anti-inflammatory analgesic (ketorolac 30 mg) and VAS≥6 using opioid (3mg morphine) (0 mean no pain - 10 mean worset pain ever)
Measured: 24 hours
Secondary outcomes (3)
Intraoperative fentanyl consumption
total fentanyl consumption
Measured: intraoperative
Heart rate intraoperative
≥ 20 % of base line
Measured: intraoperative
Timing of first rescue analgesia
first time patient needs analgesia
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 posted23 Feb 2024
- Study start1 Jun 2023
- Primary completion1 Apr 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasm FemaleStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Soliman, National Cancer Institute, Egypt
- Investigators
- ahmed soliman, Principal investigator, National Cancer Institute Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274814
- Sponsor's protocol ID
- AP23.501.038
- Status last verified
- Jul 2024
- First submitted
- 16 Feb 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Rhomboid Intercostal Block Combined With Sub-Serratus Plane Block vs Type 2 Pectoral Nerve Block in Analgesia for Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT06274814
- Acronym / sponsor ID
- AP23.501.038
- Conditions
- Breast Neoplasm Female, Analgesics
- Keywords
- Analgesics, Opioids, Breast Neoplasms, Postoperative Pain, Mastectomy, Nerve block, Breast Cancer Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 23 Feb 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 compare between U/S Guided Rhomboid Intercostal Block Combined with Sub-Serratus Plane Block vs type 2 Pectoral Nerve Block in Analgesia for Breast Cancer Surgery by measuring intraoperative hemodynamics, postoperative pain scores and morphine consumption in the first 24 h postoperative.
Detailed description
Patients will be randomly allocated into three groups based on a computerized randomization table with specific ID for each patient (23 per group). Each patient will be prepared in Preoperative Holding Area with sedation with midazolam 0.05mg/kg patients allotted to the RIB group were positioned in the lateral decubitus position with the breast on the operating side lying superiorly. The ipsilateral arm was abducted from the chest to move the scapula laterally. The RISS was performed after application of antiseptic solution. A high-frequency using a 6-13 MHz linear ultrasound probe set to B mode (SonoSite M-turbo ultrasound machine) was placed medial to the medial border of the scapula in the oblique sagittal plane. The landmarks, i.e., the trapezius muscle, rhomboid muscle, intercostal muscles, pleura, and lung, were identified in the ultrasound. Under aseptic conditions, a 100-mm 21-gauge needle was inserted at the level of T5-6 in the ultrasound view. A single dose of 20-mL 0.25% bupivacaine was injected in the interfascial plane between the rhomboid major and intercostal muscles. The spread of the local anesthetic solution under the rhomboid muscle was visualized by ultrasonography. Thereafter, the ultrasound probe was moved caudally and laterally to identify the tissue plane between the serratus anterior and external intercostal muscles for the sub-serratus block at the T8-9 level. The needle was advanced from its previous position, and an additional 20 mL of 0.25% bupivacaine was injected. All block procedures were performed by the same anesthesiologist who had administered the RIB and RISS blocks in more than 30 cases before this study. In control group (Group C), no block intervention was performed.
After disinfection, using 30 mL of levobupivacaine 0.25% (10 mL between pectoralis minor muscle and pectoralis major muscle, and 20 mL between the pectoralis major muscle and serratus muscle). With the patient in supine position. (Group B) After shifting to the operative area, all patients underwent conventional monitoring procedures including electrocardiography, noninvasive monitoring of blood pressure, and peripheral oxygen saturation measurements. Intravenous access was gained using a 22-gauge intravenous needle, and isotonic saline was infused at a rate of 15 mL kg-1 h-1. Anesthetic management was in accordance with a standard protocol. Anesthesia was induced with pre-oxygenation for 3 min followed by intravenous injection of midazolam (0.05 mg/kg), fentanyl (0.1 µg/kg), propofol (1-2 mg/kg), and atracurium (0.5 mg/kg). An endotracheal tube was used for positive-pressure ventilation to maintain the end-tidal carbon dioxide level of 35-40 mmHg.
Anesthesia was maintained using 2% sevoflurane with 50% oxygen, fentanyl (0.1 µg kg-1 min-1), and propofol (100 µg kg-1 min-1). Additionally, atracurium (0. 1 mg/kg) was administered according to the surgical protocol. Surgery (Unilateral conservative mastectomy) was started. The anesthetic dose was adjusted to maintain blood pressure within 20% of the baseline value. An additional dose of intravenous fentanyl (0.1 µg kg-1 min-1) was injected as needed. If the blood pressure decreased by > 20% from the baseline value, 250 mL of 0.9% (physiologic) saline and ephedrine (0.1 mg/kg) were administered. If the heart rate decreased to less than 50 bpm, atropine (0.5 mg/kg) was administered. At the end of the surgery, the effect of atracurium was reversed using neostigmine and atropine as needed. After the surgery, the endotracheal tube was removed when the patient fulfills criteria of extubation. Then the patient will be transferred to the PACU.
Data will be collected:
- Intraoperative assessment: (readings will be taken just after induction and every 15 min throughout surgery)
- Heart rate intraoperative.
- Mean arterial blood pressure intraoperative.
- Analgesic consumption: recorded during intraoperative period to maintain maximum 20% change of basal vital signs after exclusion of other causes. (Intraoperative fentanyl consumption)
- Postoperative:
- Recovery time: the time taken to be fully awake and responding to commands.
- Pain score: VAS score at 0, 3, 6, 9,24h post-operative.
- Hemodynamic: pulse, B.P (systolic, diastolic, and mean blood pressure) at 0,3,6,9,24h postoperative.
- Side effects (nausea, vomiting, hematoma, hypotension, bradycardia).
- Rescue analgesia plane will be given for VAS≥4 using non-steroidal anti-inflammatory analgesic (ketorolac 30 mg) and VAS≥6 using opioid (3mg morphine). Time of the first rescue analgesia together with frequency and total dose of the given drug through the 24 hours will be recorded.
- Hospital discharge.
Primary outcome:
- Total morphine consumption in first 24 hours post operative.
- VAS score postoperative.
Secondary outcome:
- Heart rate intraoperative.
- Mean arterial blood pressure intraoperative.
- Timing of first rescue analgesia.
- Intraoperative fentanyl consumption.
- Side effects (nausea, vomiting, hematoma, hypotension, bradycardia).
- Body mass index (BMI).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type 2 Pectoral Nerve Block | Active comparator | Procedure: U/S guided Type 2 Pectoral Nerve Block23 patients Type 2 Pectoral Nerve Block pecs2 Group A |
| RISS Rhomboid intercostal block combined with the sub-serratus plane block | Active comparator | Procedure: U/S guided RIB combined with the sub-serratus plane block (RISS)23 patients the RIB combined with the sub-serratus plane block (RISS) Group B |
| No block intervention | No intervention | –routine IV analgesia 23 patients no block intervention was performed. The anesthetic dose was adjusted to maintain blood pressure within 20% of the baseline value. An additional dose of intravenous fentanyl (0.1 µg kg-1 min-1) was injected as needed. Group C |
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 conservative 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 > 40 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 |
|---|---|---|
| U/S guided Type 2 Pectoral Nerve Block20 mL separates the pectoralis major and minor muscles, while 10 mL separates the serratus and pectoralis major muscles | Procedure or surgery | Type 2 Pectoral Nerve Block |
| U/S guided RIB combined with the sub-serratus plane block (RISS)he ipsilateral arm was abducted. RISS was performed. Using a 6-13 MHz linear ultrasound probe was placed medial to the medial border of the scapula in the oblique sagittal plane.. A 100-mm 21-gauge needle was inserted at the level of T5-6 in the ultrasound view. A single dose of 20-mL 0.25% bupivacaine was injected in the interfascial plane between the rhomboid major and intercostal muscles. The spread of the local anesthetic solution under the rhomboid muscle was visualized by ultrasonography. Thereafter, the ultrasound probe was moved caudally and laterally to identify the tissue plane between the serratus anterior and external intercostal muscles for the sub-serratus block at the T8-9 level. The needle was advanced from its previous position, and an additional 20 mL of 0.25% bupivacaine was injected. | Procedure or surgery | RISS Rhomboid intercostal block combined with the sub-serratus plane block |
Primary outcome
Total morphine consumption
Time frame: 24 hours
Visual Analog scale ≥6 using opioid (3mg morphine) VAS score is from 0 to 10 as 0 is no pain and 10 the wariest pain can ever experience
Visual Analog scale score postoperative
Time frame: 24 hours
Visual Analog scale≥4 using non-steroidal anti-inflammatory analgesic (ketorolac 30 mg) and VAS≥6 using opioid (3mg morphine) (0 mean no pain - 10 mean worset pain ever)
3 secondary outcomes
Intraoperative fentanyl consumption
Time frame: intraoperative
Heart rate intraoperative
Time frame: intraoperative
Timing of first rescue analgesia
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 22 Jul 2024.
- 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.
ahmed soliman principal investigator
National Cancer Institute Cairo 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 U/S guided Type 2 Pectoral Nerve Block and U/S guided RIB combined with the sub-serratus plane block (RISS) in people with Breast Neoplasm Female and Analgesics, run by National Cancer Institute, Egypt 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: finished, as of the sponsor's last update on 22 Jul 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?
Total morphine consumption (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 22 Jul 2024.