Breast CancerPhase 2/3NCT05518292
Comparison of Analgesic Efficacy of Ultrasound Guided Rhomboid Intercostal Block Versus Serratus Anterior Plane Block for Mastectomy Surgery
A Phase 2/3 study testing rhomboid intercostal block and serratus anterior plane block in people with Breast Cancer, run by Mansoura University at 1 site in Egypt.
Trial summary
Breast surgeries are usually associated with sever postoperative pain ,good perioperative analgesic technique after breast surgery is always questionable .Thoracic epidural and paravertebral blocks became the gold standard techniques for pain relief ,however they may be associated with complications such as spinal… Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- rhomboid intercostal block and serratus anterior plane block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 30 Dec 2022
- Phase
- Phase 2/3
- 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 20 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I and II
- female patients
- aged between 20-60 years,
- undergoing modified radical mastectomy surgeries
Who cannot join
- local skin infection ,
- bleeding disorder ,
- coagulation abnormality ,
- spine or chest deformity ,
- psychiatric disease,
- pregnancy
- patients with allergy to any of the drug used
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Yahya Wahba
Al Mansurah
yahya m wahba, assist prof., 01211313554, yahyawahba@gmail.com
nevert a abdel ghaffar, assist prof
About this study
Breast surgeries are usually associated with sever postoperative pain ,good perioperative analgesic technique after breast surgery is always questionable .Thoracic epidural and paravertebral blocks became the gold standard techniques for pain relief ,however they may be associated with complications such as spinal cord injury, total spinal anesthesia ,inadvertent intravascular injection and pneumothorax . Recently , fascial plane blocks have been introduced as an alternative such as erector spinae plane block and serratus plane block Serratus plane block were introduced by Blanco et al where local anesthetic injected superficial to the muscle to provide nerve block of the lateral cutaneous branches of the intercostal nerves Rhomboid intercostal block is an interfascial plane block for chest wall analgesia, it was reported in 2016 as alternative to thoracic epidural and paravertebral blocks.
Read the detailed description
This double blinded randomized(closed envelope technique) study will be conducted on eighty ASA I and II female patients aged between 20-60 years, undergoing modified radical mastectomy surgeries at Oncology Center Mansoura University (OCMU). The study will start at September 2022 and the recruitment will take approximately five months. The study duration can take about eight months. All patients undergoing general anesthesia. Informed consent will be taken after approval by the local ethics committee. The exclusion criteria included local skin infection , bleeding disorder ,coagulation abnormality ,spine or chest deformity , psychiatric disease, pregnancy and patients with allergy to any of the drug used .
Patients will be randomly assigned to either two groups according to the block used either rhomboid plane block in group R (n=30) received total volume of 20 ml of bupivacain 0.25% or serratus plane block group S (n=30) received total volume of 20 ml of bupivacaine 0.5% . The observer anesthetist and the surgeon were blinded to the solution. Operation will be performed by the same surgeon .Anesthetic management will be standardized and all patients will be premedicated with diazepam 5mg per orally at the morning of the surgery. Induction will be started with preoxygenation for 3 min, anesthesia will be induced with fentanyl (2ug/kg), 2 mg/kg propofol, muscle relaxation will be achieved by atracurium 0.05 mg kg and tracheal intubation will be achieved using suitable size of endotracheal tube . Anesthesia will be maintained with minimum alveolar concentration(MAC ) of isoflurane with air - oxygen and fentanyl 1µg/kg boluses and atracurium 0.2 mg/kg to maintain heart rate and pressure within 20% of their baseline values, the patients' lungs will be ventilated to maintain an ETCO2 of 30-35 mmHg. . Isoflurane will be discontinued at the start of skin closure, residual neuromuscular block will be antagonized with neostigmine 0.05 mg kg and atropine 0.025 mg kg and the trachea will be extubated. Heart rate ,end-tidal CO2, pulse oximetry and systolic blood pressure and diastolic blood pressure will be recorded before induction of anesthesia (baseline) and after induction of anesthesia then every 5min during surgery till end of surgery .
Post operative assessment:
In the PACU , patients were monitored for heart rate ,oxygen saturation ,systolic blood pressure and diastolic blood pressure for 1 hour postoperative by another anesthetist who was not aware of the study protocol . Patients were discharged to the surgical ward if they achieved score of 10 at modified Aldrete score .
Postoperative severity of pain which was assessed using VAS 1/2 hour after surgery, then at 1h, 2h, 4h, 6 h, 8h,12h and 24 h postoperatively . All patients were given IV ketorolac 30 mg/8 hour postoperatively and IV fentanyl 0.5µg/kg was available as rescue analgesia whenever VAS continued to be>40 mm after 30 min of ketorolac injection. Fentanyl injection could be repeated. The time for the first postoperative analgesic dose requirements and the total dose of 24hour postoperative fentanyl consumption were recorded . Postoperative nausea and vomiting (PONV) were assessed using a four-point numerical scale (0=no PONV, 1=mild nausea, 2=severe nausea or vomiting once, and 3=vomiting more than once), postoperative adverse effects and complications were recorded .
- Conditions
- Breast Cancer
- Being tested
- rhomboid intercostal block, serratus anterior plane block
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhomboid intercostal blockOther
Ultrasound guided RIB will apply with 10-12 MHz linear ultrasound transducer, in plane technique. Patients will placed in the sitting position. 22G spinal needle needle will be inserted to plane between the rhomboid muscle and intercostal muscles over the T5-6 ribs 2 cm to 3 cm medially from the medial border of the scapula. 20 ml of bupivacaine 0.25% will inject into the fascial plane.
serratus anterior plane blockOther
Patients will placed in the lateral position with the diseased side up. A 10-12 MHz linear ultrasound transducer is placed over the mid-clavicular region of the thoracic cage in a sagittal plane. The fifth rib is identified in the mid-axillary line. The following muscles are identified easily overlying the fifth rib: the latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscle (deep and inferior). As an extra-reference point, the thoracodorsal artery is used to aid the identification of the plane superficial to the serratus muscle. The needle (22G spinal needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus muscle. Under continuous ultrasound guidance, 20 ml of bupivacaine 0.25% will inject.
| Study group | Role | What they receive |
|---|---|---|
| rhomboid intercostal block | Active comparator | Ultrasound guided RIB will apply with 10-12 MHz linear ultrasound transducer, in plane technique. Patients will placed in the sitting position. 22G spinal needle needle will be inserted to plane between the rhomboid muscle and intercostal muscles over the T5-6 ribs 2 cm to 3 cm medially from the medial border of the scapula. 20 ml of bupivacaine 0.25% will inject into the fascial plane. Receives: Other: rhomboid intercostal block |
| serratus anterior plane block | Active comparator | Patients will placed in the lateral position with the diseased side up. A 10-12 MHz linear ultrasound transducer is placed over the mid-clavicular region of the thoracic cage in a sagittal plane. The fifth rib is identified in the mid-axillary line. The following muscles are identified easily overlying the fifth rib: the latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscle (deep and inferior). As an extra-reference point, the thoracodorsal artery is used to aid the identification of the plane superficial to the serratus muscle. The needle (22G spinal needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus muscle. Under continuous ultrasound guidance, 20 ml of bupivacaine 0.25% will inject. Receives: Other: serratus anterior plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
numerical analog score
0= no pain 10=sever pain
Measured: half hour after finishing mastectomy
numerical analog score
0= no pain 10=sever pain
Measured: 1 hour after finishing mastectomy
numerical analog score
0= no pain 10=sever pain
Measured: 4 hour after finishing mastectomy
numerical analog score
0= no pain 10=sever pain
Measured: 8 hour after finishing mastectomy
numerical analog score
0= no pain 10=sever pain
Measured: 12 hour after finishing mastectomy
numerical analog score
0= no pain 10=sever pain
Measured: 24 hour after finishing mastectomy
Secondary outcomes (1)
required analgesia
numerical analog score more than 4
Measured: half hour after mastectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start1 Sep 2022
- Primary completion1 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Mansoura 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nevert Adel, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518292
- Sponsor's protocol ID
- R.22.09.1830
- Status last verified
- Sep 2022
- First submitted
- 13 Aug 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Efficacy of Ultrasound Guided Rhomboid Intercostal Block Versus Serratus Anterior Plane Block for Mastectomy Surgery
- ClinicalTrials.gov ID
- NCT05518292
- Acronym / sponsor ID
- R.22.09.1830
- Conditions
- Breast Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 26 Aug 2022 (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.
Breast surgeries are usually associated with sever postoperative pain ,good perioperative analgesic technique after breast surgery is always questionable .Thoracic epidural and paravertebral blocks became the gold standard techniques for pain relief ,however they may be associated with complications such as spinal cord injury, total spinal anesthesia ,inadvertent intravascular injection and pneumothorax . Recently , fascial plane blocks have been introduced as an alternative such as erector spinae plane block and serratus plane block Serratus plane block were introduced by Blanco et al where local anesthetic injected superficial to the muscle to provide nerve block of the lateral cutaneous branches of the intercostal nerves Rhomboid intercostal block is an interfascial plane block for chest wall analgesia, it was reported in 2016 as alternative to thoracic epidural and paravertebral blocks.
Detailed description
This double blinded randomized(closed envelope technique) study will be conducted on eighty ASA I and II female patients aged between 20-60 years, undergoing modified radical mastectomy surgeries at Oncology Center Mansoura University (OCMU). The study will start at September 2022 and the recruitment will take approximately five months. The study duration can take about eight months. All patients undergoing general anesthesia. Informed consent will be taken after approval by the local ethics committee. The exclusion criteria included local skin infection , bleeding disorder ,coagulation abnormality ,spine or chest deformity , psychiatric disease, pregnancy and patients with allergy to any of the drug used .
Patients will be randomly assigned to either two groups according to the block used either rhomboid plane block in group R (n=30) received total volume of 20 ml of bupivacain 0.25% or serratus plane block group S (n=30) received total volume of 20 ml of bupivacaine 0.5% . The observer anesthetist and the surgeon were blinded to the solution. Operation will be performed by the same surgeon .Anesthetic management will be standardized and all patients will be premedicated with diazepam 5mg per orally at the morning of the surgery. Induction will be started with preoxygenation for 3 min, anesthesia will be induced with fentanyl (2ug/kg), 2 mg/kg propofol, muscle relaxation will be achieved by atracurium 0.05 mg kg and tracheal intubation will be achieved using suitable size of endotracheal tube . Anesthesia will be maintained with minimum alveolar concentration(MAC ) of isoflurane with air - oxygen and fentanyl 1µg/kg boluses and atracurium 0.2 mg/kg to maintain heart rate and pressure within 20% of their baseline values, the patients' lungs will be ventilated to maintain an ETCO2 of 30-35 mmHg. . Isoflurane will be discontinued at the start of skin closure, residual neuromuscular block will be antagonized with neostigmine 0.05 mg kg and atropine 0.025 mg kg and the trachea will be extubated. Heart rate ,end-tidal CO2, pulse oximetry and systolic blood pressure and diastolic blood pressure will be recorded before induction of anesthesia (baseline) and after induction of anesthesia then every 5min during surgery till end of surgery .
Post operative assessment:
In the PACU , patients were monitored for heart rate ,oxygen saturation ,systolic blood pressure and diastolic blood pressure for 1 hour postoperative by another anesthetist who was not aware of the study protocol . Patients were discharged to the surgical ward if they achieved score of 10 at modified Aldrete score .
Postoperative severity of pain which was assessed using VAS 1/2 hour after surgery, then at 1h, 2h, 4h, 6 h, 8h,12h and 24 h postoperatively . All patients were given IV ketorolac 30 mg/8 hour postoperatively and IV fentanyl 0.5µg/kg was available as rescue analgesia whenever VAS continued to be>40 mm after 30 min of ketorolac injection. Fentanyl injection could be repeated. The time for the first postoperative analgesic dose requirements and the total dose of 24hour postoperative fentanyl consumption were recorded . Postoperative nausea and vomiting (PONV) were assessed using a four-point numerical scale (0=no PONV, 1=mild nausea, 2=severe nausea or vomiting once, and 3=vomiting more than once), postoperative adverse effects and complications were recorded .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rhomboid intercostal block | Active comparator | Other: rhomboid intercostal blockUltrasound guided RIB will apply with 10-12 MHz linear ultrasound transducer, in plane technique. Patients will placed in the sitting position. 22G spinal needle needle will be inserted to plane between the rhomboid muscle and intercostal muscles over the T5-6 ribs 2 cm to 3 cm medially from the medial border of the scapula. 20 ml of bupivacaine 0.25% will inject into the fascial plane. |
| serratus anterior plane block | Active comparator | Other: serratus anterior plane blockPatients will placed in the lateral position with the diseased side up. A 10-12 MHz linear ultrasound transducer is placed over the mid-clavicular region of the thoracic cage in a sagittal plane. The fifth rib is identified in the mid-axillary line. The following muscles are identified easily overlying the fifth rib: the latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscle (deep and inferior). As an extra-reference point, the thoracodorsal artery is used to aid the identification of the plane superficial to the serratus muscle. The needle (22G spinal needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus muscle. Under continuous ultrasound guidance, 20 ml of bupivacaine 0.25% will inject. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA I and II
- female patients
- aged between 20-60 years,
- undergoing modified radical mastectomy surgeries
Key exclusion criteria (7 listed)
- local skin infection ,
- bleeding disorder ,
- coagulation abnormality ,
- spine or chest deformity ,
- psychiatric disease,
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 |
|---|---|---|
| rhomboid intercostal blockUltrasound guided RIB will apply with 10-12 MHz linear ultrasound transducer, in plane technique. Patients will placed in the sitting position. 22G spinal needle needle will be inserted to plane between the rhomboid muscle and intercostal muscles over the T5-6 ribs 2 cm to 3 cm medially from the medial border of the scapula. 20 ml of bupivacaine 0.25% will inject into the fascial plane. | Other | rhomboid intercostal block |
| serratus anterior plane blockPatients will placed in the lateral position with the diseased side up. A 10-12 MHz linear ultrasound transducer is placed over the mid-clavicular region of the thoracic cage in a sagittal plane. The fifth rib is identified in the mid-axillary line. The following muscles are identified easily overlying the fifth rib: the latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscle (deep and inferior). As an extra-reference point, the thoracodorsal artery is used to aid the identification of the plane superficial to the serratus muscle. The needle (22G spinal needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus muscle. Under continuous ultrasound guidance, 20 ml of bupivacaine 0.25% will inject. | Other | serratus anterior plane block |
Primary outcome
numerical analog score
Time frame: half hour after finishing mastectomy
0= no pain 10=sever pain
numerical analog score
Time frame: 1 hour after finishing mastectomy
0= no pain 10=sever pain
numerical analog score
Time frame: 4 hour after finishing mastectomy
0= no pain 10=sever pain
numerical analog score
Time frame: 8 hour after finishing mastectomy
0= no pain 10=sever pain
numerical analog score
Time frame: 12 hour after finishing mastectomy
0= no pain 10=sever pain
numerical analog score
Time frame: 24 hour after finishing mastectomy
0= no pain 10=sever pain
1 secondary outcome
required analgesia
Time frame: half hour after mastectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
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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 Phase 2/3 study testing rhomboid intercostal block and serratus anterior plane block in people with Breast Cancer, run by Mansoura 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 7 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 28 Sep 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numerical analog score (time frame: half hour after finishing mastectomy). The study lists 6 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 28 Sep 2022.