MASTECTOMYNCT04108715
Erector Spina Plane Block Versus Deep Serratus Anterior Plane Block for Post Mastectomy Analgesia
A study testing Erector spina plain block for mastectomy analgesia and Deep serratus anterior plane block in people with MASTECTOMY, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
Breast cancer surgery like Mastectomy and modified radical mastectomy are associated with significant postoperative pain, and management depends largely on patient controlled analgesia with intravenous Morphine or other opioids equivalents. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- MASTECTOMY
- What is being tested?
- Erector spina plain block for mastectomy analgesia and Deep serratus anterior plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 7 Jul 2019to 26 Feb 2020
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III patients age 18 to 75 years undergoing unilateral breast surgery
Who cannot join
- Patients refusal
- History of amide local anesthetics allergy
- Alcohol or drug abuse
- Chronic opioid intake
- Language barriers
- Patient with psychiatric disorders
Show all 9Show fewer
- Contraindications for regional anesthesia
- BMI > 40 Kg/m2
- Obstructive sleep apnea that preclude PCA opioids
Trial locations and contacts
1 site in 1 country.
About this study
Breast cancer surgery like Mastectomy and modified radical mastectomy are associated with significant postoperative pain, and management depends largely on patient controlled analgesia with intravenous Morphine or other opioids equivalents. Respiratory depression, Ileus, sedation, nausea and vomiting are some of the potential side effect of opioid treatment which prolonged hospital length of stay and increase the coast. Recent advance in ultrasound guided regional anesthesia has led to the development of two novel regional anesthesia techniques specific to chest wall analgesia; Erector spina plain block and Serratus anterior plain block, with its potential to reduce or eliminate the need for opioids to manage post-operative pain.
Read the detailed description
Experimental: erector spinae plain block After giving general anesthesia, patient is positioned in lateral decubitus with the surgical side up, and prepping para-spinous area with antiseptic solution. Ultrasound high frequency linear transducer is positioned in a para-sagittal plane at the level of fifth thoracic vertebra. Scanning of interested structures from superficial to deep planes, Trapezius muscle, Rhomboid major muscle, Erector spina muscle and transverse process of fifth thoracic vertebra.
Comparator: serratus anterior plane block After giving general anesthesia, patient is positioned in lateral decubitus, with the surgical side up. The upper arm is abducted and elevated above the head level. Under sterile aseptic technique, a linear ultrasound transducer (6-15 MHz) is placed in a sagittal oblique plane over the fourth and fifth ribs at the mid-axillary line. The following muscles are identified overlying the fourth/ fifth rib: the latissimus dorsi (superficial) and serratus anterior muscle (deep) overlying the ribs.
- Conditions
- MASTECTOMY
- Being tested
- Erector spina plain block for mastectomy analgesia, Deep serratus anterior plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spina plain block for mastectomy analgesiaProcedure or surgery
After giving general anesthesia, patient is positioned in lateral decubitus with the surgical side up, An erector Spina plain block is performed with inserting block needle (Pajunk, Geisingen, Germany) in-plane under ultrasound control until needle tip hits the transverse process, a volume of 0.3 ml/kg of bupivacaine 0.25% (Marcaine, Astra Zeneca Pharmaceuticals) is injected. Pain management assessment and analgesic consumption will be provided through patient-controlled analgesia (PCA) for 24 hours. The PCA pump is programmed to deliver 1 mg morphine bolus per press with a lockout interval of 10 min. Pain scores will be measured using eleven points numerical rating scale NRS (0 to 10) and opioids consumption will be documented at 0, 1, 4, 8 and 24 hours. Time of admission to post-anesthesia care unit PACU is considered 0 hours. Any opioid equivalents given during the first 24 hours to manage breakthrough pain will be documented
Deep serratus anterior plane blockProcedure or surgery
After giving general anesthesia, the patient is positioned in lateral decubitus, with the surgical side up. The upper arm is abducted and elevated above the head level. A block needle is introduced in-plane, targeting the plane deep to the serratus anterior muscle, and a bolus of 0.3 ml/kg bupivacaine 0.25% is injected through ultrasound guidance. Pain management assessment and analgesic consumption will be provided through patient-controlled analgesia PCA for 24 hours. The PCA pump is programmed to deliver 1 mg morphine bolus per press with a lockout interval of 10 min. Pain scores will be measured using eleven points numerical rating scale NRS (0 to 10), and opioids consumption will be documented at 0, 1, 4, 8 and 24 hours. Time of admission to PACU is considered 0 hours. Any opioid equivalents given during the first 24 hours to manage breakthrough pain will be documented
| Study group | Role | What they receive |
|---|---|---|
| ESPB GROUP | Active comparator | Erector spina plane block group Receives: Procedure: Erector spina plain block for mastectomy analgesia |
| SAPB group | Active comparator | Deep Serratus anterior plane block group Receives: Procedure: Deep serratus anterior plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Opioid consumption in the first 24 hours.
Post- operative morphine consumption measured from patient controlled analgesia pump (PCA machine)
Measured: 0 hours post- operative( 0 time is considered time to admission to post anesthesia care unit)
Cumulative Opioid consumption in the first 24 hours.
Post- operative morphine consumption measured from patient controlled analgesia pump (PCA machine)
Measured: 1 hour post-operative
Cumulative Opioid consumption in the first 24 hours.
Post- operative morphine consumption measured from patient controlled analgesia pump (PCA machine)
Measured: 4 hours post-operative
Cumulative Opioid consumption in the first 24 hours.
Post- operative morphine consumption measured from patient controlled analgesia pump (PCA machine)
Measured: 8 hours post-operative
Cumulative Opioid consumption in the first 24 hours.
Post- operative morphine consumption measured from patient controlled analgesia pump (PCA machine)
Measured: 24 hours post-operative
Post-operative pain intensity
pain intensity is measured by ( 11 point numerical scale from 0 to 10), where 0 is considered no pain, 10 is the worst pain
Measured: pain at 0 hour, 0 time is considered time to admission to post anesthesia care unit
Post-operative pain intensity
pain intensity is measured by ( 11 point numerical scale from 0 to 10), where 0 is considered no pain, 10 is the worst pain
Measured: pain at 1 hour post operative
Post-operative pain intensity
pain intensity is measured by ( 11 point numerical scale from 0 to 10), where 0 is considered no pain, 10 is the worst pain
Measured: pain at 4 hours post operative
Post-operative pain intensity
pain intensity is measured by ( 11 point numerical scale from 0 to 10), where 0 is considered no pain, 10 is the worst pain
Measured: pain at 8 hours post operative
Post-operative pain intensity
pain intensity is measured by ( 11 point numerical scale from 0 to 10), where 0 is considered no pain, 10 is the worst pain
Measured: pain at 24 hours post operative
Secondary outcomes (1)
Time to patient mobilization
Recording first time patient is able to mobilize without assistance
Measured: First 24 hours post operative( 0 time is considered time to admission to post anesthesia care unit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start7 Jul 2019
- Primary completion2 Feb 2020
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Khaled Thallaj, King Saud University
- Investigators
- Ahmed Thallaj, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108715
- Sponsor's protocol ID
- E-19-3943
- Status last verified
- Feb 2020
- First submitted
- 7 Jul 2019
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spina Plane Block Versus Deep Serratus Anterior Plane Block for Post Mastectomy Analgesia
- ClinicalTrials.gov ID
- NCT04108715
- Acronym / sponsor ID
- E-19-3943
- Conditions
- MASTECTOMY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 7 Jul 2019 (actual)
- Primary completion
- 2 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 30 Sep 2019 (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 cancer surgery like Mastectomy and modified radical mastectomy are associated with significant postoperative pain, and management depends largely on patient controlled analgesia with intravenous Morphine or other opioids equivalents. Respiratory depression, Ileus, sedation, nausea and vomiting are some of the potential side effect of opioid treatment which prolonged hospital length of stay and increase the coast. Recent advance in ultrasound guided regional anesthesia has led to the development of two novel regional anesthesia techniques specific to chest wall analgesia; Erector spina plain block and Serratus anterior plain block, with its potential to reduce or eliminate the need for opioids to manage post-operative pain.
Detailed description
Experimental: erector spinae plain block After giving general anesthesia, patient is positioned in lateral decubitus with the surgical side up, and prepping para-spinous area with antiseptic solution. Ultrasound high frequency linear transducer is positioned in a para-sagittal plane at the level of fifth thoracic vertebra. Scanning of interested structures from superficial to deep planes, Trapezius muscle, Rhomboid major muscle, Erector spina muscle and transverse process of fifth thoracic vertebra.
Comparator: serratus anterior plane block After giving general anesthesia, patient is positioned in lateral decubitus, with the surgical side up. The upper arm is abducted and elevated above the head level. Under sterile aseptic technique, a linear ultrasound transducer (6-15 MHz) is placed in a sagittal oblique plane over the fourth and fifth ribs at the mid-axillary line. The following muscles are identified overlying the fourth/ fifth rib: the latissimus dorsi (superficial) and serratus anterior muscle (deep) overlying the ribs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESPB GROUP | Active comparator | Procedure: Erector spina plain block for mastectomy analgesiaErector spina plane block group |
| SAPB group | Active comparator | Procedure: Deep serratus anterior plane blockDeep Serratus anterior plane block group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I-III patients age 18 to 75 years undergoing unilateral breast surgery
Key exclusion criteria (9 listed)
- Patients refusal
- History of amide local anesthetics allergy
- Alcohol or drug abuse
- Chronic opioid intake
- Language barriers
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 |
|---|---|---|
| Erector spina plain block for mastectomy analgesiaAfter giving general anesthesia, patient is positioned in lateral decubitus with the surgical side up, An erector Spina plain block is performed with inserting block needle (Pajunk, Geisingen, Germany) in-plane under ultrasound control until needle tip hits the transverse process, a volume of 0.3 ml/kg of bupivacaine 0.25% (Marcaine, Astra Zeneca Pharmaceuticals) is injected. Pain management assessment and analgesic consumption will be provided through patient-controlled analgesia (PCA) for 24 hours. The PCA pump is programmed to deliver 1 mg morphine bolus per press with a lockout interval of 10 min. Pain scores will be measured using eleven points numerical rating scale NRS (0 to 10) and opioids consumption will be documented at 0, 1, 4, 8 and 24 hours. Time of admission to post-anesthesia care unit PACU is considered 0 hours. Any opioid equivalents given during the first 24 hours to manage breakthrough pain will be documented | Procedure or surgery | ESPB GROUP |
| Deep serratus anterior plane blockAfter giving general anesthesia, the patient is positioned in lateral decubitus, with the surgical side up. The upper arm is abducted and elevated above the head level. A block needle is introduced in-plane, targeting the plane deep to the serratus anterior muscle, and a bolus of 0.3 ml/kg bupivacaine 0.25% is injected through ultrasound guidance. Pain management assessment and analgesic consumption will be provided through patient-controlled analgesia PCA for 24 hours. The PCA pump is programmed to deliver 1 mg morphine bolus per press with a lockout interval of 10 min. Pain scores will be measured using eleven points numerical rating scale NRS (0 to 10), and opioids consumption will be documented at 0, 1, 4, 8 and 24 hours. Time of admission to PACU is considered 0 hours. Any opioid equivalents given during the first 24 hours to manage breakthrough pain will be documented | Procedure or surgery | SAPB group |
Primary outcome
Cumulative Opioid consumption in the first 24 hours.
Time frame: 0 hours post- operative( 0 time is considered time to admission to post anesthesia care unit)
Post- operative morphine consumption measured from patient controlled analgesia pump (PCA machine)
Cumulative Opioid consumption in the first 24 hours.
Time frame: 1 hour post-operative
Post- operative morphine consumption measured from patient controlled analgesia pump (PCA machine)
Cumulative Opioid consumption in the first 24 hours.
Time frame: 4 hours post-operative
Post- operative morphine consumption measured from patient controlled analgesia pump (PCA machine)
Cumulative Opioid consumption in the first 24 hours.
Time frame: 8 hours post-operative
Post- operative morphine consumption measured from patient controlled analgesia pump (PCA machine)
Cumulative Opioid consumption in the first 24 hours.
Time frame: 24 hours post-operative
Post- operative morphine consumption measured from patient controlled analgesia pump (PCA machine)
Post-operative pain intensity
Time frame: pain at 0 hour, 0 time is considered time to admission to post anesthesia care unit
pain intensity is measured by ( 11 point numerical scale from 0 to 10), where 0 is considered no pain, 10 is the worst pain
Post-operative pain intensity
Time frame: pain at 1 hour post operative
pain intensity is measured by ( 11 point numerical scale from 0 to 10), where 0 is considered no pain, 10 is the worst pain
Post-operative pain intensity
Time frame: pain at 4 hours post operative
pain intensity is measured by ( 11 point numerical scale from 0 to 10), where 0 is considered no pain, 10 is the worst pain
Post-operative pain intensity
Time frame: pain at 8 hours post operative
pain intensity is measured by ( 11 point numerical scale from 0 to 10), where 0 is considered no pain, 10 is the worst pain
Post-operative pain intensity
Time frame: pain at 24 hours post operative
pain intensity is measured by ( 11 point numerical scale from 0 to 10), where 0 is considered no pain, 10 is the worst pain
1 secondary outcome
Time to patient mobilization
Time frame: First 24 hours post operative( 0 time is considered time to admission to post anesthesia care unit)
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 3 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for MASTECTOMY
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Preoperative vs. Pathologic Size in Breast Cancer: A Prospective Study
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Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
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A Study of Different Skin Care Approaches to Prevent Skin Reactions in People With Breast Cancer Receiving Radiation Therapy After Mastectomy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Thallaj principal investigator
King Saud 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 Erector spina plain block for mastectomy analgesia and Deep serratus anterior plane block in people with MASTECTOMY, run by King Saud University at 1 site in Saudi Arabia.
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 1 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 3 Mar 2020. 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 Saudi Arabia. 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?
Cumulative Opioid consumption in the first 24 hours. (time frame: 0 hours post- operative( 0 time is considered time to admission to post anesthesia care unit)). The study lists 10 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 3 Mar 2020.