Breast NeoplasmsNCT06322316
Analgesic Efficacy of U/S Retrolaminar Block and Erector Spinae Plane Block in MRM
A study testing The Ultrasound-guided Retrolaminar Block Group and The Ultrasound-guided Erector Spinae Plane Block Group in people with Breast Neoplasms and Analgesia, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
Modified radical mastectomy (MRM) is the most commonly performed surgical procedure in breast cancer patients and is usually associated with severe postoperative pain. The peripheral nerve block techniques were suggested to reduce acuter post-mastectomy pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Neoplasms, Analgesia
- What is being tested?
- The Ultrasound-guided Retrolaminar Block Group and The Ultrasound-guided Erector Spinae Plane Block Group
- 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
- 1 Oct 2022to 1 Apr 2023
- 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
- 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 anesthetics, opioids).
- History of psychological disorders and/or chronic pain.
- Contraindication to regional anesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
- Patient refusal.
Show all 10Show fewer
- 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: Analgesic Efficacy of Ultrasound-guided Retrolaminar Block and Erector Spinae Plane Block in Modified Radical Mastectomy: A Randomized Controlled Study
Modified radical mastectomy (MRM) is the most commonly performed surgical procedure in breast cancer patients and is usually associated with severe postoperative pain. The peripheral nerve block techniques were suggested to reduce acuter post-mastectomy pain. The study compared the analgesic efficacy of retrolaminar block (RLB) and ESPB in patients undergoing MRM.
Read the detailed description
Introduction Globally, breast cancer remains the most prevalent cancer among females, with an estimated incidence of 31% and mortality of 15%. Surgery is foremost in managing breast cancer, where modified radical mastectomy (MRM) is the most commonly performed procedure. This procedure implicates vigorous tissue dissection and seroma formation with many postoperative complications. Pain is the main complaint following MRM, affecting up to 50% of women, and 25-60% develop persistent chronic postmastectomy pain.
Therefore, adequate pain control is crucial to postoperative management after MRM. Numerous analgesic methods were suggested to reduce acuter post-mastectomy pain. Opioid-related adverse events include nausea and vomiting, respiratory depression, sedation, and dizziness.
Most mastectomy-related pain originates from the chest wall's sensory nerves. The peripheral nerve block techniques have gained increased interest in treating postoperative pain. The erector spinae plane block (ESPB) is one of these techniques that proved effective in various surgical procedures, including breast surgery. It encompasses injecting the local anesthetic (LA) solution deep into the erector spinae muscle (ESM), which eventually spreads through the paravertebral space. Ultrasound-guided retrolaminar block (RLB) is another approach that was found to be effective for pain relief after thoracic surgery. In RLB, LA is injected into the space between the ESM and the lamina of the thoracic vertebra.
Both techniques are considered variants of paravertebral block; however, prospective studies comparing RLB and ESPB are limited. Therefore, this study was designed to compare the analgesic efficacy of ultrasound-guided retrolaminar block and erector spinae plane block in patients undergoing modified radical mastectomy.
Patients and Methods:
This randomized single-blinded study was conducted at the National Cancer Institute (NCI), Cairo University from October 2022 and finished March 2023. The study was approved by the institutional review board and the scientific committee of the anesthesia department of the NCI and Faculty of Medicine, Cairo University. All participants provided written informed consent before enrollment in the study after fully explaining the procedures and possible complications.
The study involved 60 female patients scheduled for MRM under general anesthesia with the following inclusion criteria: age 18 to 65, ASA class II or III, and body mass index (BMI) of 20-35 kg/m2. Patients with known sensitivity or contraindication to the drugs used in the study, history of psychological disorders or chronic pain syndromes, contraindication to regional anesthesia (local sepsis, pre-existing peripheral neuropathies, coagulopathy), severe respiratory or cardiac conditions, advanced liver or kidney disease were excluded from the study.
The patients were randomly allocated into one of two equal groups using computer-generated random numbers in opaque closed envelopes. An independent statistician performed the randomization. The grouping was revealed only when the patient was transferred to the pre-anesthetic room. The RLB Group (n=30) received a preoperative ultrasound-guided retrolaminar block using 20 ml levobupivacaine 0.25%. The ESPB Group (n=30) received a preoperative ultrasound-guided erector spinae plane block using 20 ml levobupivacaine 0.25%.
Preoperative assessment included thorough history taking, physical examination, and laboratory and radiological investigations. The patients were instructed to report pain using the Numeric Pain Rating Scale (NPRS), where 0 = no pain and 10 = worst imaginable pain. All patients were premedicated with IV midazolam 0.01-0.02 mg/kg 30 minutes before surgery. In both blocks, a Fujifilm Sonosite M-Turbo Ultrasound system linear probe was used (SN.04RQZ6) . After performing blocks lung ultrasound was performed to exclude pneumothorax.
Retrolaminar Block Technique The block was performed under complete aseptic precautions. The ultrasound probe was placed on the back in a transverse orientation on the lateral side of the posterior median line to identify the lamina of the 5th vertebra, ESM, and transversospinalis muscles of the target segment. A skin wheal using 3 ml of 1% lidocaine was made 2-3 cm medial to the transducer. A 38-mm 22-gauge regional block needle was advanced using an in-plane technique. When the puncture needle touched the lamina, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% levobupivacaine was administered between the transversospinalis muscle and lamina. The LA diffusion between the lamina and the ESM indicated a successful puncture.
Erector spinae plane block:
The ultrasound probe was placed on the back in a transverse orientation to identify the tip of the T5 transverse process as flat, squared-off acoustic shadows with a faint image of the pleura visible. When the tip of the transverse process was centered on the ultrasound screen, the probe was rotated to a longitudinal orientation. In the parasagittal view, the following layers were visible superficial to the acoustic shadows of the transverse processes: skin and subcutaneous tissue, trapezius, ESM, and T5 transverse process. A skin wheal was made using 3 ml of 1% lidocaine; then, the block needle was inserted in-plane in a cranial-to-caudal direction until contact was made with the T5 transverse process. The correct location of the needle tip in the fascial plane deep to the ESM was confirmed by injecting 0.5-1.0 ml of normal saline and seeing the fluid lifting the ESM off the transverse process without distending the muscle. After aspiration to avoid intravascular injection, 20 ml levobupivacaine 0.25% was injected.
Anesthetic Management:
All patients were monitored continuously using electrocardiography, non-invasive blood pressure, peripheral O2 saturation, temperature probe, and end-tidal CO2 throughout the surgical procedure. Anesthesia was induced using fentanyl 2 μg/kg and propofol 2 mg/kg IV. Tracheal intubation was facilitated using rocuronium 0.5 mg/kg IV. Anesthesia was maintained with inhaled sevoflurane 2.0-2.5% in oxygen-enriched air (FiO2=0.5). Maintenance doses of rocuronium 0.1 mg\kg were provided every 30 minutes. Paracetamol 500 mg and ketorolac 30 mg were provided as a part of multimodal analgesia. Rescue analgesia of fentanyl 1 μg/kg was given if the mean arterial blood pressure (MAP) or heart rate (HR) rose above 20% of baseline levels. The patients were mechanically ventilated at appropriate settings to keep end-tidal CO2 at 30-35 mmHg.
The first reading of MAP and HR was taken before induction of general anesthesia as a baseline reading. Then, another reading was taken immediately before incision and at 30-minute intervals intraoperatively. Hypotension (reduction > 20% of baseline reading) was treated with 0.9% normal saline and/or 5 mg ephedrine in incremental doses to maintain MAP above 70 mmHg. The residual neuromuscular blockade was reversed using neostigmine 0.05 mg/kg and atropine 0.02 mg/kg. Extubation was performed after complete recovery of the airway reflexes.
Postoperatively the NPRS score, MAP, and HR were noted immediately on arrival and every 2 hours. Multimodal analgesia was provided as paracetamol 500 mg/6 hours and ketorolac 30 mg/8 hours IV. Rescue analgesia was provided as IV morphine 3 mg boluses when the patient indicated an NPRS score ≥ 4. The total amount of morphine given in 24 hours was recorded, and a maximum dose of 0.5 mg/kg/24 hours of morphine was allowed. Side effects such as nausea, vomiting, sedation, hallucination, and respiratory depression (respiratory rate < 10/minute) were recorded. Moderate or severe postoperative nausea and vomiting (PONV) was treated with 0.1 mg/kg of IV ondansetron.
- Conditions
- Breast Neoplasms, Analgesia
- Being tested
- The Ultrasound-guided Retrolaminar Block Group, The Ultrasound-guided Erector Spinae Plane Block Group
- Keywords
- Analgesics, Opioids, Breast Neoplasms, Postoperative Pain, Mastectomy, Nerve block
- Medical subject headings
- Breast Neoplasms, Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Ultrasound-guided Retrolaminar Block GroupProcedure or surgery
Also called RLB
The ultrasound probe was placed on the back in a transverse orientation on the lateral side of the posterior median line to identify the lamina of the 5th vertebra, ESM, and transversospinalis muscles of the target segment.
A 38-mm 22-gauge regional block needle was advanced using an in-plane technique. When the puncture needle touched the lamina, 20 mL of 0.25% levobupivacaine was administered between the transversospinalis muscle and lamina. The LA diffusion between the lamina and the ESM indicated a successful puncture.
The Ultrasound-guided Erector Spinae Plane Block GroupProcedure or surgery
Also called ESPB
The ultrasound probe was placed on the back in a transverse orientation to identify the tip of the T5 transverse process as flat, squared-off acoustic shadows with a faint image of the pleura visible. When the tip of the transverse process was centered on the ultrasound screen, the probe was rotated to a longitudinal orientation. In the parasagittal view, the following layers were visible superficial to the acoustic shadows of the transverse processes: skin and subcutaneous tissue, trapezius, ESM, and T5 transverse process.
The block needle was inserted in-plane in a cranial-to-caudal direction until contact was made with the T5 transverse process. The correct location of the needle tip in the fascial plane deep to the ESM was confirmed by injecting 0.5-1.0 ml of normal saline and seeing the fluid lifting the ESM off the transverse process without distending the muscle. Then 20 ml levobupivacaine 0.25% was injected.
| Study group | Role | What they receive |
|---|---|---|
| The Ultrasound-guided Retrolaminar Block (RLB) Group | Active comparator | Received a preoperative ultrasound-guided retrolaminar block using 20 ml levobupivacaine 0.25% Ultrasound probe was placed on the back in a transverse orientation on the lateral side of the posterior median line to identify the lamina of the 5th vertebra, ESM, and transversospinalis muscles of the target segment. Receives: Procedure: The Ultrasound-guided Retrolaminar Block Group |
| The Ultrasound-guided Erector Spinae Plane Block (ESPB) Group | Active comparator | Received a preoperative ultrasound-guided erector spinae plane block using 20 ml levobupivacaine 0.25%.
ultrasound probe was placed on the back in a transverse orientation to identify the tip of the T5 transverse process as flat, squared-off acoustic shadows with a faint image of the pleura visible. When the tip of the transverse process was centered on the ultrasound screen, the probe was rotated to a longitudinal orientation. In the parasagittal view The block needle was inserted in-plane in a cranial-to-caudal direction until contact was made with the T5 transverse process. Receives: Procedure: The Ultrasound-guided Erector Spinae Plane Block Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the total morphine consumed postoperatively for 24 hours
the total morphine consumed postoperatively for 24 hours
Measured: 24 hours
Secondary outcomes (3)
the total intraoperative fentanyl consumption
the total intraoperative fentanyl consumption when hemodynamics intraoperative >20%
Measured: intraoperative
duration of analgesia
Duration of analgesia was defined as the time from the block performance to the first postoperative rescue analgesic administrated upon patient request
Measured: at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively
postoperative nausea and vomiting PONV as side effect of morphine
nausea and vomiting scores using a four-point verbal scale
Measured: at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Oct 2022
- Primary completion1 Mar 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To determine the analgesic effect of ultrasound guided Retrolaminar Block and Erector Spinae Plane Block in patients undergoing modified radical mastectomy regarding the following : 1-Post-operative opioid (morphine) consumption in the 1st 24 hours 2- Postoperative 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
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Soliman, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322316
- Sponsor's protocol ID
- MS-492-2022
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: till publication
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Ultrasound-guided Retrolaminar Block and Erector Spinae Plane Block in Modified Radical Mastectomy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06322316
- Acronym / sponsor ID
- MS-492-2022
- Conditions
- Breast Neoplasms, Analgesia
- Keywords
- Analgesics, Opioids, Breast Neoplasms, Postoperative Pain, Mastectomy, Nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 21 Mar 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.
Modified radical mastectomy (MRM) is the most commonly performed surgical procedure in breast cancer patients and is usually associated with severe postoperative pain. The peripheral nerve block techniques were suggested to reduce acuter post-mastectomy pain. The study compared the analgesic efficacy of retrolaminar block (RLB) and ESPB in patients undergoing MRM.
Detailed description
Introduction Globally, breast cancer remains the most prevalent cancer among females, with an estimated incidence of 31% and mortality of 15%. Surgery is foremost in managing breast cancer, where modified radical mastectomy (MRM) is the most commonly performed procedure. This procedure implicates vigorous tissue dissection and seroma formation with many postoperative complications. Pain is the main complaint following MRM, affecting up to 50% of women, and 25-60% develop persistent chronic postmastectomy pain.
Therefore, adequate pain control is crucial to postoperative management after MRM. Numerous analgesic methods were suggested to reduce acuter post-mastectomy pain. Opioid-related adverse events include nausea and vomiting, respiratory depression, sedation, and dizziness.
Most mastectomy-related pain originates from the chest wall's sensory nerves. The peripheral nerve block techniques have gained increased interest in treating postoperative pain. The erector spinae plane block (ESPB) is one of these techniques that proved effective in various surgical procedures, including breast surgery. It encompasses injecting the local anesthetic (LA) solution deep into the erector spinae muscle (ESM), which eventually spreads through the paravertebral space. Ultrasound-guided retrolaminar block (RLB) is another approach that was found to be effective for pain relief after thoracic surgery. In RLB, LA is injected into the space between the ESM and the lamina of the thoracic vertebra.
Both techniques are considered variants of paravertebral block; however, prospective studies comparing RLB and ESPB are limited. Therefore, this study was designed to compare the analgesic efficacy of ultrasound-guided retrolaminar block and erector spinae plane block in patients undergoing modified radical mastectomy.
Patients and Methods:
This randomized single-blinded study was conducted at the National Cancer Institute (NCI), Cairo University from October 2022 and finished March 2023. The study was approved by the institutional review board and the scientific committee of the anesthesia department of the NCI and Faculty of Medicine, Cairo University. All participants provided written informed consent before enrollment in the study after fully explaining the procedures and possible complications.
The study involved 60 female patients scheduled for MRM under general anesthesia with the following inclusion criteria: age 18 to 65, ASA class II or III, and body mass index (BMI) of 20-35 kg/m2. Patients with known sensitivity or contraindication to the drugs used in the study, history of psychological disorders or chronic pain syndromes, contraindication to regional anesthesia (local sepsis, pre-existing peripheral neuropathies, coagulopathy), severe respiratory or cardiac conditions, advanced liver or kidney disease were excluded from the study.
The patients were randomly allocated into one of two equal groups using computer-generated random numbers in opaque closed envelopes. An independent statistician performed the randomization. The grouping was revealed only when the patient was transferred to the pre-anesthetic room. The RLB Group (n=30) received a preoperative ultrasound-guided retrolaminar block using 20 ml levobupivacaine 0.25%. The ESPB Group (n=30) received a preoperative ultrasound-guided erector spinae plane block using 20 ml levobupivacaine 0.25%.
Preoperative assessment included thorough history taking, physical examination, and laboratory and radiological investigations. The patients were instructed to report pain using the Numeric Pain Rating Scale (NPRS), where 0 = no pain and 10 = worst imaginable pain. All patients were premedicated with IV midazolam 0.01-0.02 mg/kg 30 minutes before surgery. In both blocks, a Fujifilm Sonosite M-Turbo Ultrasound system linear probe was used (SN.04RQZ6) . After performing blocks lung ultrasound was performed to exclude pneumothorax.
Retrolaminar Block Technique The block was performed under complete aseptic precautions. The ultrasound probe was placed on the back in a transverse orientation on the lateral side of the posterior median line to identify the lamina of the 5th vertebra, ESM, and transversospinalis muscles of the target segment. A skin wheal using 3 ml of 1% lidocaine was made 2-3 cm medial to the transducer. A 38-mm 22-gauge regional block needle was advanced using an in-plane technique. When the puncture needle touched the lamina, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% levobupivacaine was administered between the transversospinalis muscle and lamina. The LA diffusion between the lamina and the ESM indicated a successful puncture.
Erector spinae plane block:
The ultrasound probe was placed on the back in a transverse orientation to identify the tip of the T5 transverse process as flat, squared-off acoustic shadows with a faint image of the pleura visible. When the tip of the transverse process was centered on the ultrasound screen, the probe was rotated to a longitudinal orientation. In the parasagittal view, the following layers were visible superficial to the acoustic shadows of the transverse processes: skin and subcutaneous tissue, trapezius, ESM, and T5 transverse process. A skin wheal was made using 3 ml of 1% lidocaine; then, the block needle was inserted in-plane in a cranial-to-caudal direction until contact was made with the T5 transverse process. The correct location of the needle tip in the fascial plane deep to the ESM was confirmed by injecting 0.5-1.0 ml of normal saline and seeing the fluid lifting the ESM off the transverse process without distending the muscle. After aspiration to avoid intravascular injection, 20 ml levobupivacaine 0.25% was injected.
Anesthetic Management:
All patients were monitored continuously using electrocardiography, non-invasive blood pressure, peripheral O2 saturation, temperature probe, and end-tidal CO2 throughout the surgical procedure. Anesthesia was induced using fentanyl 2 μg/kg and propofol 2 mg/kg IV. Tracheal intubation was facilitated using rocuronium 0.5 mg/kg IV. Anesthesia was maintained with inhaled sevoflurane 2.0-2.5% in oxygen-enriched air (FiO2=0.5). Maintenance doses of rocuronium 0.1 mg\kg were provided every 30 minutes. Paracetamol 500 mg and ketorolac 30 mg were provided as a part of multimodal analgesia. Rescue analgesia of fentanyl 1 μg/kg was given if the mean arterial blood pressure (MAP) or heart rate (HR) rose above 20% of baseline levels. The patients were mechanically ventilated at appropriate settings to keep end-tidal CO2 at 30-35 mmHg.
The first reading of MAP and HR was taken before induction of general anesthesia as a baseline reading. Then, another reading was taken immediately before incision and at 30-minute intervals intraoperatively. Hypotension (reduction > 20% of baseline reading) was treated with 0.9% normal saline and/or 5 mg ephedrine in incremental doses to maintain MAP above 70 mmHg. The residual neuromuscular blockade was reversed using neostigmine 0.05 mg/kg and atropine 0.02 mg/kg. Extubation was performed after complete recovery of the airway reflexes.
Postoperatively the NPRS score, MAP, and HR were noted immediately on arrival and every 2 hours. Multimodal analgesia was provided as paracetamol 500 mg/6 hours and ketorolac 30 mg/8 hours IV. Rescue analgesia was provided as IV morphine 3 mg boluses when the patient indicated an NPRS score ≥ 4. The total amount of morphine given in 24 hours was recorded, and a maximum dose of 0.5 mg/kg/24 hours of morphine was allowed. Side effects such as nausea, vomiting, sedation, hallucination, and respiratory depression (respiratory rate < 10/minute) were recorded. Moderate or severe postoperative nausea and vomiting (PONV) was treated with 0.1 mg/kg of IV ondansetron.
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 Retrolaminar Block and Erector Spinae Plane Block in patients undergoing modified radical mastectomy regarding the following : 1-Post-operative opioid (morphine) consumption in the 1st 24 hours 2- Postoperative 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 |
|---|---|---|
| The Ultrasound-guided Retrolaminar Block (RLB) Group | Active comparator | Procedure: The Ultrasound-guided Retrolaminar Block GroupReceived a preoperative ultrasound-guided retrolaminar block using 20 ml levobupivacaine 0.25% Ultrasound probe was placed on the back in a transverse orientation on the lateral side of the posterior median line to identify the lamina of the 5th vertebra, ESM, and transversospinalis muscles of the target segment. |
| The Ultrasound-guided Erector Spinae Plane Block (ESPB) Group | Active comparator | Procedure: The Ultrasound-guided Erector Spinae Plane Block GroupReceived a preoperative ultrasound-guided erector spinae plane block using 20 ml levobupivacaine 0.25%. ultrasound probe was placed on the back in a transverse orientation to identify the tip of the T5 transverse process as flat, squared-off acoustic shadows with a faint image of the pleura visible. When the tip of the transverse process was centered on the ultrasound screen, the probe was rotated to a longitudinal orientation. In the parasagittal view The block needle was inserted in-plane in a cranial-to-caudal direction until contact was made with the T5 transverse process. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not 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 anesthetics, opioids).
- History of psychological disorders and/or chronic pain.
- Contraindication to regional anesthesia 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 |
|---|---|---|
| The Ultrasound-guided Retrolaminar Block GroupAlso: RLBThe ultrasound probe was placed on the back in a transverse orientation on the lateral side of the posterior median line to identify the lamina of the 5th vertebra, ESM, and transversospinalis muscles of the target segment. A 38-mm 22-gauge regional block needle was advanced using an in-plane technique. When the puncture needle touched the lamina, 20 mL of 0.25% levobupivacaine was administered between the transversospinalis muscle and lamina. The LA diffusion between the lamina and the ESM indicated a successful puncture. | Procedure or surgery | The Ultrasound-guided Retrolaminar Block (RLB) Group |
| The Ultrasound-guided Erector Spinae Plane Block GroupAlso: ESPBThe ultrasound probe was placed on the back in a transverse orientation to identify the tip of the T5 transverse process as flat, squared-off acoustic shadows with a faint image of the pleura visible. When the tip of the transverse process was centered on the ultrasound screen, the probe was rotated to a longitudinal orientation. In the parasagittal view, the following layers were visible superficial to the acoustic shadows of the transverse processes: skin and subcutaneous tissue, trapezius, ESM, and T5 transverse process. The block needle was inserted in-plane in a cranial-to-caudal direction until contact was made with the T5 transverse process. The correct location of the needle tip in the fascial plane deep to the ESM was confirmed by injecting 0.5-1.0 ml of normal saline and seeing the fluid lifting the ESM off the transverse process without distending the muscle. Then 20 ml levobupivacaine 0.25% was injected. | Procedure or surgery | The Ultrasound-guided Erector Spinae Plane Block (ESPB) Group |
Primary outcome
the total morphine consumed postoperatively for 24 hours
Time frame: 24 hours
the total morphine consumed postoperatively for 24 hours
3 secondary outcomes
the total intraoperative fentanyl consumption
Time frame: intraoperative
duration of analgesia
Time frame: at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively
postoperative nausea and vomiting PONV as side effect of morphine
Time frame: at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively
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 21 Mar 2024.
- Individual participant dataSharing planned: No. till publication
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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.
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 The Ultrasound-guided Retrolaminar Block Group and The Ultrasound-guided Erector Spinae Plane Block Group in people with Breast Neoplasms and Analgesia, 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 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 21 Mar 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 total morphine consumed postoperatively for 24 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 21 Mar 2024.