AnalgesiaNCT04531215
Ultrasound Guided Retrolaminar Versus Erector Spinae Plane Block for Postoperative Analgesia
A study testing ultrasound guided Retrolaminar Block and ultrasound guided Erector Spinae Plane in people with Analgesia, run by Zagazig University at 1 site in Egypt.
Trial summary
Thoracic epidural anesthesia (TEA) and paravertebral block (PVB) have been utilized to give perioperative regional anesthesia in the trunk. TEA is technically troublesome in some cases, and is associated with a danger of serious complications, such as epidural hematoma, nerve injury, and hypotension. Read more about this study
- Who is it for?
- Ages 21 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- ultrasound guided Retrolaminar Block and ultrasound guided Erector Spinae Plane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 1 Apr 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 21 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient acceptance.
- 21 - 64 years of age.
- American Society of Anesthesiologist physical status class I,II.
- Body Mass Index 25-35 kg/m2.
- Female patient undergoing elective unilateral modified radical mastectomy under general anesthesia.
Who cannot join
- Coagulation disorders or anticoagulant therapy.
- Known allergy to study drugs (Bupivacaine, Fentanyl)
- Infection at the injection site.
- Patients having chronic pain or on pain treatment.
- Advanced renal, respiratory, hepatic or cardiovascular disorders.
- Uncooperative patients.
Show all 9Show fewer
- Duration of surgery > 3hours.
- Pregnant or lactating females.
- Metastasis.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Zagazig University, Faculty of medicine
Zagazig
Alshaimaa Kamel, M.D, 01005593169 ext. 002, AlshaimaaKamel80@yahoo.com
Alshaimaa Kamel, M.D
About this study
Official title: Ultrasound Guided Retrolaminar Versus Erector Spinae Plane Block for Postoperative Analgesia in Modified Radical Mastectomy
Thoracic epidural anesthesia (TEA) and paravertebral block (PVB) have been utilized to give perioperative regional anesthesia in the trunk. TEA is technically troublesome in some cases, and is associated with a danger of serious complications, such as epidural hematoma, nerve injury, and hypotension. PVB has the benefit of perception of the needle position using ultrasonography. However, PVB is also additionally connected with a danger of serious complications, such as pneumothorax, hypotension, or nerve injury. Newer approaches to deal with PVB have been the focal point of numerous techniques lately; these methodologies incorporate retrolaminar block (RLB) and erector spinae plane block (ESPB)
Read the detailed description
Modified radical mastectomy is one of the commonly performed breast surgery. Postoperative pain following mastectomy should be minimized, as in a number of women it may chronically persist for months in the form of post-mastectomy pain syndrome.
Morphine administration for acute pain after mastectomy surgery has many side effects. Regional block techniques as para-vertebral block and thoracic epidural anesthesia have possible complications and technical difficulties.
The new alternative regional techniques such as erector spinae plane block and retrolaminar block are clinical trials for providing a safe and easy with good hemodynamic and recovery profile with adequate perioperative analgesia for a large section of patients undergoing mastectomy operation in order to reduce opioids consumption and subsequently avoid opioid-related adverse effects.
As percent of post-operative rescue analgesia is 16.7% and 60% for RLB group and ESPB group respectively. So, sample size is 46 patients (23 patients in each group). Sample was calculated using OPEN EPI program with confidence level 95% and power 80%.
- Conditions
- Analgesia
- Being tested
- ultrasound guided Retrolaminar Block, ultrasound guided Erector Spinae Plane
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided Retrolaminar BlockDrug
ultrasound guided Retrolaminar Block (RLB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side
ultrasound guided Erector Spinae PlaneDrug
ultrasound guided Erector Spinae Plane Block (ESPB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side.
| Study group | Role | What they receive |
|---|---|---|
| ultrasound guided Retrolaminar Block | Active comparator | ultrasound guided Retrolaminar Block (RLB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side. Receives: Drug: ultrasound guided Retrolaminar Block |
| ultrasound guided erector spinae | Active comparator | ultrasound guided Erector Spinae Plane Block (ESPB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side. Receives: Drug: ultrasound guided Erector Spinae Plane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total fentanyl dose.
The anesthesiologist will administer intravenous fentanyl 0.5 μg/kg when the heart rate or blood pressure of the patients increased >20% from basal measurements after exclusion of other causes.
Measured: from induction to end of surgery
Secondary outcomes (6)
pain intensity by Visual Analogue Scale
- Static and dynamic pain scores (VAS) at 30 minutes, 2, 4, 8, 12, 18 and 24 hours post-operatively. pain intensity will be evaluated by Visual Analogue Scale (VAS). VAS is a 10 cm horizontal line labeled "no pain" at one end and "worst pain" imaginable on the other end. The patient will be asked to mark on this line where the intensity of the patient lies.
Measured: at 30 minutes then at 2, 4, 8, 12, 18 and 24 hours post-operatively.
Time of requirement of rescue dose of Fentanyl.
Time of requirement of rescue dose of Fentanyl.
Measured: up to 24hour postoperative
Total amount of postoperative Fentanyl
Total amount of Fentanyl consumed during the first 24 hours after surgery.
Measured: up to 24hour postoperative
Post-operative nausea and vomiting
- Post-operative nausea and vomiting will be noticed, recorded using a categorical scoring system (0 = none, 1 = mild, 2 = moderate, 3 = severe) and treated, Ondansetron 4 mg IV will be administered in case of reported nausea and/or vomiting
Measured: up to 24hour postoperative
Complications including hypotension MAP < 60, bradycardia HR < 60b/m, nausea, vomiting and allergic reactions.
Complications including hypotension MAP < 60, bradycardia HR < 60b/m, nausea, vomiting and allergic reactions.
Measured: up to 24hour postoperative
Overall patient satisfaction
- Overall patient satisfaction at the end of the 24 hours post-operative using short assessment patient satisfaction scale (SAPS scale fully satisfied, neutral satisfied or unsatisfied)
Measured: up to 24hour postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start1 Feb 2021
- Primary completion30 Mar 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Zagazig 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, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alshaimaa Abdel Fattah Kamel, Zagazig University
- Investigators
- Alshaimaa Kamel, M.D, Study chair, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531215
- Sponsor's protocol ID
- 6236
- Status last verified
- Feb 2024
- First submitted
- 25 Aug 2020
- Last updated
- 1 Mar 2024
- 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 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Retrolaminar Versus Erector Spinae Plane Block for Postoperative Analgesia in Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT04531215
- Acronym / sponsor ID
- 6236
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 28 Aug 2020 (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.
Thoracic epidural anesthesia (TEA) and paravertebral block (PVB) have been utilized to give perioperative regional anesthesia in the trunk. TEA is technically troublesome in some cases, and is associated with a danger of serious complications, such as epidural hematoma, nerve injury, and hypotension. PVB has the benefit of perception of the needle position using ultrasonography. However, PVB is also additionally connected with a danger of serious complications, such as pneumothorax, hypotension, or nerve injury. Newer approaches to deal with PVB have been the focal point of numerous techniques lately; these methodologies incorporate retrolaminar block (RLB) and erector spinae plane block (ESPB)
Detailed description
Modified radical mastectomy is one of the commonly performed breast surgery. Postoperative pain following mastectomy should be minimized, as in a number of women it may chronically persist for months in the form of post-mastectomy pain syndrome.
Morphine administration for acute pain after mastectomy surgery has many side effects. Regional block techniques as para-vertebral block and thoracic epidural anesthesia have possible complications and technical difficulties.
The new alternative regional techniques such as erector spinae plane block and retrolaminar block are clinical trials for providing a safe and easy with good hemodynamic and recovery profile with adequate perioperative analgesia for a large section of patients undergoing mastectomy operation in order to reduce opioids consumption and subsequently avoid opioid-related adverse effects.
As percent of post-operative rescue analgesia is 16.7% and 60% for RLB group and ESPB group respectively. So, sample size is 46 patients (23 patients in each group). Sample was calculated using OPEN EPI program with confidence level 95% and power 80%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound guided Retrolaminar Block | Active comparator | Drug: ultrasound guided Retrolaminar Blockultrasound guided Retrolaminar Block (RLB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side. |
| ultrasound guided erector spinae | Active comparator | Drug: ultrasound guided Erector Spinae Planeultrasound guided Erector Spinae Plane Block (ESPB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side. |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient acceptance.
- 21 - 64 years of age.
- American Society of Anesthesiologist physical status class I,II.
- Body Mass Index 25-35 kg/m2.
- Female patient undergoing elective unilateral modified radical mastectomy under general anesthesia.
Key exclusion criteria (9 listed)
- Coagulation disorders or anticoagulant therapy.
- Known allergy to study drugs (Bupivacaine, Fentanyl)
- Infection at the injection site.
- Patients having chronic pain or on pain treatment.
- Advanced renal, respiratory, hepatic or cardiovascular disorders.
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 |
|---|---|---|
| ultrasound guided Retrolaminar Blockultrasound guided Retrolaminar Block (RLB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side | Drug | ultrasound guided Retrolaminar Block |
| ultrasound guided Erector Spinae Planeultrasound guided Erector Spinae Plane Block (ESPB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side. | Drug | ultrasound guided erector spinae |
Primary outcome
Total fentanyl dose.
Time frame: from induction to end of surgery
The anesthesiologist will administer intravenous fentanyl 0.5 μg/kg when the heart rate or blood pressure of the patients increased >20% from basal measurements after exclusion of other causes.
6 secondary outcomes
pain intensity by Visual Analogue Scale
Time frame: at 30 minutes then at 2, 4, 8, 12, 18 and 24 hours post-operatively.
Time of requirement of rescue dose of Fentanyl.
Time frame: up to 24hour postoperative
Total amount of postoperative Fentanyl
Time frame: up to 24hour postoperative
Post-operative nausea and vomiting
Time frame: up to 24hour postoperative
Complications including hypotension MAP < 60, bradycardia HR < 60b/m, nausea, vomiting and allergic reactions.
Time frame: up to 24hour postoperative
Overall patient satisfaction
Time frame: up to 24hour postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
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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.
Alshaimaa Kamel, M.D study chair
Zagazig 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 ultrasound guided Retrolaminar Block and ultrasound guided Erector Spinae Plane in people with Analgesia, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 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 1 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alshaimaa Kamel, M.D (01005593169 ext. 002, AlshaimaaKamel80@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total fentanyl dose. (time frame: from induction to end of surgery). 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 1 Mar 2024.