Modified Radical MastectomyPhase 4NCT04778267
Effectiveness of Combined Erector Spinae and Pecto-intercostal Fascial Plane Blocks Versus Thoracic Paravertebral Block in Perioperative Pain in Modified Radical Mastectomy
A Phase 4 study testing Bupivacaine Hydrochloride and Dexamethasone phosphate in people with Modified Radical Mastectomy, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Erector spinae plane block (ESPB) is a new evolving fascial pain block in the era of regional anaesthesia. ESPB was applied in varieties of surgeries and provided an eminent role in trauma patient especially those with fracture ribs. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Modified Radical Mastectomy
- What is being tested?
- Bupivacaine Hydrochloride and Dexamethasone phosphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Mar 2021to 10 Mar 2023
- Phase
- Phase 4
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • 18-60 years of age
- ASA I-II
- Elective unilateral modified radical mastectomy with axillary lymph node dissection
- Body weight (50-90 kg)
Who cannot join
- • Patient refusal
- Known allergy to any of the study drugs
- Bleeding disorders (platelets < 50 000, PC <60%, INR>1.5)
- Infection at the site of needle puncture or sepsis
- Obesity (BMI > 30 kg/m2)
- Chronic opioid user eg; morphine addict
Show all 9Show fewer
- Chronic pain disease eg certain cancer patients, rheumatological disease
- Inability to comprehend or use the numeric rating pain scoring system
- Psychiatric illness eg, psychiatric patients on hypnotic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Combined U.S. Guided Erector Spinae and Pecto-intercostal Fascial Plane Blocks Versus U.S.Guided Thoracic Paravertebral Block in Controlling Perioperative Pain in Modified Radical Mastectomy, a Blinded Randomized Controlled Trial
Erector spinae plane block (ESPB) is a new evolving fascial pain block in the era of regional anaesthesia. ESPB was applied in varieties of surgeries and provided an eminent role in trauma patient especially those with fracture ribs. ESPB exhibits simple, safe and easy technique with minimal or no sympathetic blockade effects, thus gaining popularity in wide range of surgeries. The optimum effective dose of local anaesthetic, the effective volume of drug used for desired dermatomes. Comparison with different regional blocks is preferable to know the optimum analgesic technique for those population of patients (4). Many studies have already compared solo ESPB with thoracic epidural analgesia (TEA), thoracic paravertebral block (TPVB), serratus anterior plane block (SAPB) and pectoral nerves block. Only few case reports described the combination effect of rhomboid intercostal, transversus thoracic muscle and parasternal plane blocks to ESPB in modified radical mastectomy.
Read the detailed description
patients scheduled for modified radical mastectomy and axillary dissection under general anesthesia (GA) will be included in the study. The patients will be randomly allocated by a computer-generated table into one of the two study groups.Thoracic paravertebral block group (TPV group) and combined erector spinae and pecto-intercostal fascial plane blocks group (ES-PI group).
0.25% bupivacaine and 1 mg dexamethasone will be injected with different volumes in each block.
The first time to ask for rescue analgesia post-operatively will be measured. Using MedCalc Software version 14 (MedCalc Software bvba, Ostend, Belgium), 24 patients (12 patients per group) were calculated for a relative difference of 10% (0.635 hours) in the time to first analgesic request between both groups, with a study power of 95% and an alpha error of 0.05. This number will be increased to 30 patients (15 patients per group) to compensate for possible dropouts.
Analysis of data will be performed using the Statistical Package for Social Science (SPSS) software, version 21 for Microsoft Windows (SPSS Inc., Chicago, iL, USA). Categorical data will be reported as numbers and percentages and will be analyzed using the chi-squared test. Continuous data will be checked for normality using the Kolmogorov-Smirnov test. Normally distributed data will be presented as means (standard deviations) and will be analyzed using the unpaired student t-test. Skewed data will be expressed as medians(quartiles) and will be analyzed using the Mann Whitney U test. For repeated measures, a two-way repeated measures ANOVA will be used to evaluate block (between-groups factor) and time (repeated measures)". Post-hoc pairwise comparison will be performed using the Bonferroni test. A P value of 0.05 or less will be considered significant.
- Conditions
- Modified Radical Mastectomy
- Being tested
- Bupivacaine Hydrochloride, Dexamethasone phosphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine HydrochlorideDrug
Also called marcaine
We hypothesize that combined ESPB and PIPB are as effective as TPVB in controlling perioperative pain in patients undergoing modified radical mastectomy (MRM) with lesser complications using bupivacaine hydrocloride
Dexamethasone phosphateDrug
Also called decadrone
used as additive to bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| TPVB (thoracic paravertebral block) | Active comparator | TPVB will be performed in the sitting position A high frequency linear ultrasound probe will be applied in the parasagittal plane approximately 2-3 cm lateral to the midline till identification of the 3rd thoracic vertebra (T3) in the same side of surgery. Then the transducer will be moved progressively more medially until transverse processes are identified.The image acquired will have the transverse process located superiorly and an image of lower rib located inferiorly on the screen.The needle tip is to be observed to enter through the superior costotransverse ligament and loss of resistance sensation will be experienced. After confirming the anterior displacement of pleura with 2-3 mL of local anesthetic (LA), 30 ml of 0.25% bupivacaine and 4 mg dexamethasone will be administered for the block. Receives: Drug: Bupivacaine Hydrochloride; Drug: Dexamethasone phosphate |
| ES-PI (erector spinae-pectointercostal block) | Experimental | ESPB In the second group (ES-PI) Using a high frequency linear ultrasound probe, it will be located in a longitudinal orientation at the level of T3 spinous process and then will be placed 3 cm laterally from the midline to the side involved in the surgery. .a 22-gauge block needle will be inserted in-plane at an angle of 30-40°. 20 mL of 0.25% bupivacaine hydrochloride and 3 mg dexamethasone will be injected in the plane deeper to the erector spinae muscle.
PIPB While the patient is in the supine position, a high frequency linear probe will be placed parallel to the long axis of the sternum at a distance 2-3 cm from the attachment of the second rib and sternum to identify the Pectoralis major muscle, external intercostal muscles and the second rib in the superficial plane. by separation of fascial layers of between the external intercostal and the pectoralis muscles, a total of 10 ml of 0.25% bupivacaine and 1 mg dexamethasone will be injected. Receives: Drug: Bupivacaine Hydrochloride; Drug: Dexamethasone phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The first time to ask for rescue analgesia post-operatively
after how many hours postoperatively the patient will ask for analgesia
Measured: 48 hours
Secondary outcomes (2)
The total postoperative opioid consumption (in the first 48 hrs)
total milligrams of opioid given to the patient in the 48 hours postoperatively
Measured: 48 hours
NRS scores
Postoperative pain will be assessed, using numeric rating scale (NRS)
Measured: 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start12 Mar 2021
- Primary completion9 Mar 2023
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Modified Radical MastectomyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The effectiveness of combined ultrasound guided erector spinae and pectointercostal fascial plane blocks versus ultrasound guided thoracic paravertebral block in controlling perioperative pain in modified radical mastectomy, a blinded randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Farouk Kassem Habib, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778267
- Sponsor's protocol ID
- MD-342-2020
- Status last verified
- Mar 2023
- First submitted
- 15 Feb 2021
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- 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 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Combined U.S. Guided Erector Spinae and Pecto-intercostal Fascial Plane Blocks Versus U.S.Guided Thoracic Paravertebral Block in Controlling Perioperative Pain in Modified Radical Mastectomy, a Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04778267
- Acronym / sponsor ID
- MD-342-2020
- Conditions
- Modified Radical Mastectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Erector spinae plane block (ESPB) is a new evolving fascial pain block in the era of regional anaesthesia. ESPB was applied in varieties of surgeries and provided an eminent role in trauma patient especially those with fracture ribs. ESPB exhibits simple, safe and easy technique with minimal or no sympathetic blockade effects, thus gaining popularity in wide range of surgeries. The optimum effective dose of local anaesthetic, the effective volume of drug used for desired dermatomes. Comparison with different regional blocks is preferable to know the optimum analgesic technique for those population of patients (4). Many studies have already compared solo ESPB with thoracic epidural analgesia (TEA), thoracic paravertebral block (TPVB), serratus anterior plane block (SAPB) and pectoral nerves block. Only few case reports described the combination effect of rhomboid intercostal, transversus thoracic muscle and parasternal plane blocks to ESPB in modified radical mastectomy.
Detailed description
patients scheduled for modified radical mastectomy and axillary dissection under general anesthesia (GA) will be included in the study. The patients will be randomly allocated by a computer-generated table into one of the two study groups.Thoracic paravertebral block group (TPV group) and combined erector spinae and pecto-intercostal fascial plane blocks group (ES-PI group).
0.25% bupivacaine and 1 mg dexamethasone will be injected with different volumes in each block.
The first time to ask for rescue analgesia post-operatively will be measured. Using MedCalc Software version 14 (MedCalc Software bvba, Ostend, Belgium), 24 patients (12 patients per group) were calculated for a relative difference of 10% (0.635 hours) in the time to first analgesic request between both groups, with a study power of 95% and an alpha error of 0.05. This number will be increased to 30 patients (15 patients per group) to compensate for possible dropouts.
Analysis of data will be performed using the Statistical Package for Social Science (SPSS) software, version 21 for Microsoft Windows (SPSS Inc., Chicago, iL, USA). Categorical data will be reported as numbers and percentages and will be analyzed using the chi-squared test. Continuous data will be checked for normality using the Kolmogorov-Smirnov test. Normally distributed data will be presented as means (standard deviations) and will be analyzed using the unpaired student t-test. Skewed data will be expressed as medians(quartiles) and will be analyzed using the Mann Whitney U test. For repeated measures, a two-way repeated measures ANOVA will be used to evaluate block (between-groups factor) and time (repeated measures)". Post-hoc pairwise comparison will be performed using the Bonferroni test. A P value of 0.05 or less will be considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The effectiveness of combined ultrasound guided erector spinae and pectointercostal fascial plane blocks versus ultrasound guided thoracic paravertebral block in controlling perioperative pain in modified radical mastectomy, a blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| TPVB (thoracic paravertebral block) | Active comparator | Drug: Bupivacaine Hydrochloride, Drug: Dexamethasone phosphateTPVB will be performed in the sitting position A high frequency linear ultrasound probe will be applied in the parasagittal plane approximately 2-3 cm lateral to the midline till identification of the 3rd thoracic vertebra (T3) in the same side of surgery. Then the transducer will be moved progressively more medially until transverse processes are identified.The image acquired will have the transverse process located superiorly and an image of lower rib located inferiorly on the screen.The needle tip is to be observed to enter through the superior costotransverse ligament and loss of resistance sensation will be experienced. After confirming the anterior displacement of pleura with 2-3 mL of local anesthetic (LA), 30 ml of 0.25% bupivacaine and 4 mg dexamethasone will be administered for the block. |
| ES-PI (erector spinae-pectointercostal block) | Experimental | Drug: Bupivacaine Hydrochloride, Drug: Dexamethasone phosphateESPB In the second group (ES-PI) Using a high frequency linear ultrasound probe, it will be located in a longitudinal orientation at the level of T3 spinous process and then will be placed 3 cm laterally from the midline to the side involved in the surgery. .a 22-gauge block needle will be inserted in-plane at an angle of 30-40°. 20 mL of 0.25% bupivacaine hydrochloride and 3 mg dexamethasone will be injected in the plane deeper to the erector spinae muscle. PIPB While the patient is in the supine position, a high frequency linear probe will be placed parallel to the long axis of the sternum at a distance 2-3 cm from the attachment of the second rib and sternum to identify the Pectoralis major muscle, external intercostal muscles and the second rib in the superficial plane. by separation of fascial layers of between the external intercostal and the pectoralis muscles, a total of 10 ml of 0.25% bupivacaine and 1 mg dexamethasone will be injected. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • 18-60 years of age
Key exclusion criteria (9 listed)
- • Patient refusal
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 |
|---|---|---|
| Bupivacaine HydrochlorideAlso: marcaineWe hypothesize that combined ESPB and PIPB are as effective as TPVB in controlling perioperative pain in patients undergoing modified radical mastectomy (MRM) with lesser complications using bupivacaine hydrocloride | Drug | ES-PI (erector spinae-pectointercostal block), TPVB (thoracic paravertebral block) |
| Dexamethasone phosphateAlso: decadroneused as additive to bupivacaine | Drug | ES-PI (erector spinae-pectointercostal block), TPVB (thoracic paravertebral block) |
Primary outcome
The first time to ask for rescue analgesia post-operatively
Time frame: 48 hours
after how many hours postoperatively the patient will ask for analgesia
2 secondary outcomes
The total postoperative opioid consumption (in the first 48 hrs)
Time frame: 48 hours
NRS scores
Time frame: 48 hours postoperative
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 13 Mar 2023.
- 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.
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 Phase 4 study testing Bupivacaine Hydrochloride and Dexamethasone phosphate in people with Modified Radical Mastectomy, run by Kasr El Aini Hospital 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 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: finished, as of the sponsor's last update on 13 Mar 2023. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 first time to ask for rescue analgesia post-operatively (time frame: 48 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 13 Mar 2023.