Breast Cancer SurgeryerectspinaeNCT03769428
Postoperative Analgesia in Breast Cancer Surgery: Safety and Efficiency of Ultrasound Guided Erector Spinae Plane Block
A study testing erector spinae plane block in people with Breast Cancer Surgery and Postoperative Analgesia, run by Ben marzouk Sofiene at 1 site in Tunisia.
Trial summary
Breast cancer surgery is one of the most common surgeries, due to the high incidence of breast cancer. Unfortunately, patients experience significant postoperative acute pain, placing them at risk for increased clinical morbidity and the development of disabling chronic pain which may rich up to 55% . Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Breast Cancer Surgery, Postoperative Analgesia
- What is being tested?
- erector spinae plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTunisia
- Study dates
- 17 Dec 2018to 30 Jun 2019
- 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 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 25-65 years old
- ASA I-II
- Undergoing unilateral breast cancer surgery
Who cannot join
- obesity (body mass index >40 kg/m2)
- Preoperative chronic dependence upon opioid and NSAID medications
- History of psychiatric or neurological disease
- Patients with chronic pain syndromes
- allergy to local anaesthetics
- other contraindications to peripheral nerve blocks
- Patients' refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Analgesia in Breast Cancer Surgery: Safety and Efficiency of Ultrasound Guided Erector Spinae Plane Block, a Randomized Controlled Double Blinded Trial
Breast cancer surgery is one of the most common surgeries, due to the high incidence of breast cancer. Unfortunately, patients experience significant postoperative acute pain, placing them at risk for increased clinical morbidity and the development of disabling chronic pain which may rich up to 55% . The intensity of perioperative pain experienced by the patient is one of the best predictors of chronic pain.
However, postoperative analgesia in breast cancer surgery is difficult due to the extensive nature of the surgery and the complex innervation of the breast.
Read more
Several newly described regional anesthesia techniques exist to control perioperative pain, including the Paravertebral block (PVB) which has been proved to be the most effective one. The anatomic proximity of the pleura and central neuraxial system makes it a particularly challenging technique and carrying a risk of pneumothorax.
The Erector Spinae Plane Block (ESPB) is a novel interfascial plane block described by Forero et al in September 2016. Local anesthetic injection is performed beneath the erector spinae muscle. Local anesthetic (LA) expected to achieve paravertebral spread of three vertebral levels cranially and four levels caudally, blocking the dorsal and ventral rami of the spinal nerves.The easy, fast and safe execution of ESPB makes it a promising technique in the context of surgical pain during breast cancer surgery.
There is no sufficient randomized controlled trials that assess the effectiveness of ESPB in controlling post-operative breast surgery pain.
The main purpose of this study is to evaluate the postoperative analgesic effect of Ultrasound-guided ESPB in patients undergoing breast cancer surgery.
Read the detailed description
It is a prospective double blind trial. Sixty female patient aged between 20-65 years old with American Society of Anesthesiologists (ASA) physical status I-II and scheduled for elective surgery for breast cancer were included in the study. Only unilateral surgical procedures will be included. The patients will be randomized into two groups:
Group B (ESP block): Patients in the experimental arm will receive an ESPB prior to induction of general anesthetic.
Group P: (sham ESP block): Patients allocated to the placebo-control arm will receive a placebo injection of normal saline in almost identical fashion to that of the ESP block.
Intravenous access will be obtained with an 18-gauge intravenous (IV) cannula in the contralateral upper limb of the surgical site and monitors (pulse oximeter, electrocardiography, non-invasive blood pressure (NIBP) will be applied.
All blocks will be performed before induction of general anesthesia.
ESPB technique:
The ESPB will be done in the sitting position using linear ultrasound probe (L10) of MySonoU6 machine. The blocks will be performed at the T4-T5 level of the spine using an in-plane approach. A linear probe will be placed 2-3 cm laterally to the spine using a sagittal approach. Three muscles will be identified superficial to the transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. Local anesthetic (LA) is injected between the erector spinae muscle and transverse process. Following confirmation of the correct position of the needle tip with administration of 0.5-1 ml of the fluid a total of 40 mL of fluid will be injected next. The distribution will be observed in both cranial and caudal directions.
- Group B (ESP block) will receive 150 mg of Ropivacaine : 40cc of Ropivacaine (3.75mg/cc).
- Group P (Sham ESP block) will receive 40 cc of normal saline.
General Anesthesia:
All patients will receive pre-oxygenation with 100% O2 for 3 min. Anesthesia will be induced by using fentanyl 2μg/kg, Propofol 2-3 mg/kg and Atracurium 0.5 mg/kg. During anesthesia maintenance, monitoring will include Pulse Oximetry, an Electrocardiogram, Non-Invasive Blood Pressure (NIBP), end-tidal Carbon Dioxide, End-Tidal Sevoflurane, and Fraction of Inspired Oxygen.
The reinjection of 0.5μg/kg of fentanyl will be given intraoperatively either when heart rate or Non-Invasive Blood Pressure (NIBP) report an increase by more than 20% of the basal records.
Paracetamol 1 g IV and Ketoprofen 100 mg intramuscular (IM) will be administered for postoperative analgesia at the end of surgery. Anesthesia will be discontinued and tracheal extubation will be done once patient fulfilled the extubation criteria. In the recovery room, all patients will be given a patient-controlled analgesia device (PCA) containing morphine 1 mg/ml-1 ,set to deliver a 1 mg bolus dose of morphine, with an 5 min lockout time and 12mg 1 h limit. Postoperative pain will be assessed using a visual analogue scales (VAS) scores ranging from zero (no pain) to 10 (worst imaginable pain). The VAS scores will be recorded at 1,2,4,8 6, 12, 16, 20 and 24 h postoperatively.If VAS scores are superior to 6 the investigators will resort to rescue analgesia as following: If 6<VAS<8: paracetamol 1g IV will be administered and if VAS>8: paracetamol 1g IV associated to ketoprofen100mg IM.
Incidence of nausea and vomiting, and total morphine consumption during the 24-h postoperative period will be recorded.
- Conditions
- Breast Cancer Surgery, Postoperative Analgesia
- Being tested
- erector spinae plane block, sham erector spinae plane block
- Keywords
- opioid consumption, erector spinae plane block, breast surgery, analgesia, PCA morphine, Locoregional anesthesia, breast cancer surgery
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spinae plane blockProcedure or surgery
The ESPB will be done in a sitting position using linear ultrasound probe (L10) of MySonoU6 machine. The blocks will be performed at the T4-T5 level of the spine using an in-plane approach. A linear probe will be placed 2-3 cm laterally to the spine using a sagittal approach. Three muscles will be identified superficial to the transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. Local anesthetic (LA) is injected between the erector spinae muscle and transverse process. Following confirmation of the correct position of the needle tip with administration of 0.5-1 ml of the fluid. Then 40cc of Ropivacaine (3.75mg/cc) will be injected .The distribution will be observed in both cranial and caudal directions.
sham erector spinae plane blockProcedure or surgery
The sham ESPB will be done in a sitting position using linear ultrasound probe (L10) of MySonoU6 machine. The blocks will be performed at the T4-T5 level of the spine using an in-plane approach. A linear probe will be placed 2-3 cm laterally to the spine using a sagittal approach. Three muscles will be identified superficial to the transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. Following confirmation of the correct position of the needle tip with administration of 0.5-1 ml of the fluid a total of 40 mL of fluid will be injected next between the erector spinae muscle and transverse process. Then 40cc of normal saline will be injected.The distribution will be observed in both cranial and caudal directions.
| Study group | Role | What they receive |
|---|---|---|
| group B:ESP block | Active comparator | Patients in the experimental arm will receive an erector spinae plane block prior to induction of general anesthetic :- 150 mg of Ropivacaine : 40cc of Ropivacaine (3.75mg/cc)
* An intravenous patient controlled analgesia device will be given to the patients postoperatively Receives: Procedure: erector spinae plane block |
| group P: Sham ESP block | Placebo comparator | Patients allocated to the placebo-control arm will receive a sham erector spinae plane block .they will receive a placebo injection of normal saline in a fashion almost identical to that of the ESP block:- 40 cc of normal saline will be injected
-An intravenous patient controlled analgesia device will be given to the patients postoperatively Receives: Procedure: sham erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing morphine consumption rates within 24h postoperative
All patients will be provided with IV morphine PCA and morphine consumption within 24 hour postoperatively will be recorded for both groups.
Measured: The first 24 hours postoperative
Secondary outcomes (7)
Assessment of pain in postoperative period via visual analogue scales (VAS) .
Postoperative pain will be assessed using a VAS ranging from 0 (no pain) to 10 (worst imaginable pain).The VAS will be recorded at 1,2,4,8 6, 12 ,16,20 and 24 h postoperatively.
Measured: The first 24 hours postoperative
Total morphine demand
The investigators will compare total morphine demand in both groups during the first 24h after surgery.
Measured: During 24 hours postoperative
Time to first request for morphine
The investigators will compare the timing of the first request for morphine in both groups during the first 24h after surgery.
Measured: During 24 hours postoperative
Requirement of rescue analgesia
The investigators will record and compare the timing of first rescue analgesia and total rescue analgesia requirement.
If 6<VAS<8: paracetamol 1g iv will be administered If VAS>8:paracetamol 1g iv associated to ketoprofen100mg IM will be administered.
Measured: During 24 hours postoperative
Total intraoperative consumption of Fentanyl.
The investigators will record the total dose of Fentanyl (µg) required during surgery.
Fentanyl will be given intraoperatively either when heart rate or Non-Invasive Blood Pressure (NIBP) report an increase by more than 20% of the basal records.
Measured: Intraoperative period
Postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting will be recorded.
Measured: within 24 hours postoperative
Morphine related side effects
The occurence of morphine related side effects such as pruritus,urinary retention,hypotension,respiratory distress and sedation will be recorded.
Measured: During 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start17 Dec 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurgeryStudies 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
- Model description
- Parallel Assignment
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ben marzouk Sofiene
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ben marzouk Sofiene, University Tunis El Manar
- Investigators
- Hayen Maghrebi, PROFESSOR, Study chair, UNIVERSITY OF TUNIS EL MANAR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769428
- Sponsor's protocol ID
- erector-spinae
- Acronym
- erectspinae
- Status last verified
- Dec 2019
- First submitted
- 27 Nov 2018
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesia in Breast Cancer Surgery: Safety and Efficiency of Ultrasound Guided Erector Spinae Plane Block, a Randomized Controlled Double Blinded Trial
- ClinicalTrials.gov ID
- NCT03769428
- Acronym / sponsor ID
- erectspinae / erector-spinae
- Conditions
- Breast Cancer Surgery, Postoperative Analgesia
- Keywords
- opioid consumption, erector spinae plane block, breast surgery, analgesia, PCA morphine, Locoregional anesthesia, breast cancer surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ben marzouk SofieneUniversity, hospital or other
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 7 Dec 2018 (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 is one of the most common surgeries, due to the high incidence of breast cancer. Unfortunately, patients experience significant postoperative acute pain, placing them at risk for increased clinical morbidity and the development of disabling chronic pain which may rich up to 55% . The intensity of perioperative pain experienced by the patient is one of the best predictors of chronic pain.
However, postoperative analgesia in breast cancer surgery is difficult due to the extensive nature of the surgery and the complex innervation of the breast.
Several newly described regional anesthesia techniques exist to control perioperative pain, including the Paravertebral block (PVB) which has been proved to be the most effective one. The anatomic proximity of the pleura and central neuraxial system makes it a particularly challenging technique and carrying a risk of pneumothorax.
The Erector Spinae Plane Block (ESPB) is a novel interfascial plane block described by Forero et al in September 2016. Local anesthetic injection is performed beneath the erector spinae muscle. Local anesthetic (LA) expected to achieve paravertebral spread of three vertebral levels cranially and four levels caudally, blocking the dorsal and ventral rami of the spinal nerves.The easy, fast and safe execution of ESPB makes it a promising technique in the context of surgical pain during breast cancer surgery.
There is no sufficient randomized controlled trials that assess the effectiveness of ESPB in controlling post-operative breast surgery pain.
The main purpose of this study is to evaluate the postoperative analgesic effect of Ultrasound-guided ESPB in patients undergoing breast cancer surgery.
Detailed description
It is a prospective double blind trial. Sixty female patient aged between 20-65 years old with American Society of Anesthesiologists (ASA) physical status I-II and scheduled for elective surgery for breast cancer were included in the study. Only unilateral surgical procedures will be included. The patients will be randomized into two groups:
Group B (ESP block): Patients in the experimental arm will receive an ESPB prior to induction of general anesthetic.
Group P: (sham ESP block): Patients allocated to the placebo-control arm will receive a placebo injection of normal saline in almost identical fashion to that of the ESP block.
Intravenous access will be obtained with an 18-gauge intravenous (IV) cannula in the contralateral upper limb of the surgical site and monitors (pulse oximeter, electrocardiography, non-invasive blood pressure (NIBP) will be applied.
All blocks will be performed before induction of general anesthesia.
ESPB technique:
The ESPB will be done in the sitting position using linear ultrasound probe (L10) of MySonoU6 machine. The blocks will be performed at the T4-T5 level of the spine using an in-plane approach. A linear probe will be placed 2-3 cm laterally to the spine using a sagittal approach. Three muscles will be identified superficial to the transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. Local anesthetic (LA) is injected between the erector spinae muscle and transverse process. Following confirmation of the correct position of the needle tip with administration of 0.5-1 ml of the fluid a total of 40 mL of fluid will be injected next. The distribution will be observed in both cranial and caudal directions.
- Group B (ESP block) will receive 150 mg of Ropivacaine : 40cc of Ropivacaine (3.75mg/cc).
- Group P (Sham ESP block) will receive 40 cc of normal saline.
General Anesthesia:
All patients will receive pre-oxygenation with 100% O2 for 3 min. Anesthesia will be induced by using fentanyl 2μg/kg, Propofol 2-3 mg/kg and Atracurium 0.5 mg/kg. During anesthesia maintenance, monitoring will include Pulse Oximetry, an Electrocardiogram, Non-Invasive Blood Pressure (NIBP), end-tidal Carbon Dioxide, End-Tidal Sevoflurane, and Fraction of Inspired Oxygen.
The reinjection of 0.5μg/kg of fentanyl will be given intraoperatively either when heart rate or Non-Invasive Blood Pressure (NIBP) report an increase by more than 20% of the basal records.
Paracetamol 1 g IV and Ketoprofen 100 mg intramuscular (IM) will be administered for postoperative analgesia at the end of surgery. Anesthesia will be discontinued and tracheal extubation will be done once patient fulfilled the extubation criteria. In the recovery room, all patients will be given a patient-controlled analgesia device (PCA) containing morphine 1 mg/ml-1 ,set to deliver a 1 mg bolus dose of morphine, with an 5 min lockout time and 12mg 1 h limit. Postoperative pain will be assessed using a visual analogue scales (VAS) scores ranging from zero (no pain) to 10 (worst imaginable pain). The VAS scores will be recorded at 1,2,4,8 6, 12, 16, 20 and 24 h postoperatively.If VAS scores are superior to 6 the investigators will resort to rescue analgesia as following: If 6<VAS<8: paracetamol 1g IV will be administered and if VAS>8: paracetamol 1g IV associated to ketoprofen100mg IM.
Incidence of nausea and vomiting, and total morphine consumption during the 24-h postoperative period will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| group B:ESP block | Active comparator | Procedure: erector spinae plane blockPatients in the experimental arm will receive an erector spinae plane block prior to induction of general anesthetic :- 150 mg of Ropivacaine : 40cc of Ropivacaine (3.75mg/cc) * An intravenous patient controlled analgesia device will be given to the patients postoperatively |
| group P: Sham ESP block | Placebo comparator | Procedure: sham erector spinae plane blockPatients allocated to the placebo-control arm will receive a sham erector spinae plane block .they will receive a placebo injection of normal saline in a fashion almost identical to that of the ESP block:- 40 cc of normal saline will be injected -An intravenous patient controlled analgesia device will be given to the patients postoperatively |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 25-65 years old
- ASA I-II
- Undergoing unilateral breast cancer surgery
Key exclusion criteria (7 listed)
- obesity (body mass index >40 kg/m2)
- Preoperative chronic dependence upon opioid and NSAID medications
- History of psychiatric or neurological disease
- Patients with chronic pain syndromes
- allergy to local anaesthetics
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 spinae plane blockThe ESPB will be done in a sitting position using linear ultrasound probe (L10) of MySonoU6 machine. The blocks will be performed at the T4-T5 level of the spine using an in-plane approach. A linear probe will be placed 2-3 cm laterally to the spine using a sagittal approach. Three muscles will be identified superficial to the transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. Local anesthetic (LA) is injected between the erector spinae muscle and transverse process. Following confirmation of the correct position of the needle tip with administration of 0.5-1 ml of the fluid. Then 40cc of Ropivacaine (3.75mg/cc) will be injected .The distribution will be observed in both cranial and caudal directions. | Procedure or surgery | group B:ESP block |
| sham erector spinae plane blockThe sham ESPB will be done in a sitting position using linear ultrasound probe (L10) of MySonoU6 machine. The blocks will be performed at the T4-T5 level of the spine using an in-plane approach. A linear probe will be placed 2-3 cm laterally to the spine using a sagittal approach. Three muscles will be identified superficial to the transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. Following confirmation of the correct position of the needle tip with administration of 0.5-1 ml of the fluid a total of 40 mL of fluid will be injected next between the erector spinae muscle and transverse process. Then 40cc of normal saline will be injected.The distribution will be observed in both cranial and caudal directions. | Procedure or surgery | group P: Sham ESP block |
Primary outcome
Comparing morphine consumption rates within 24h postoperative
Time frame: The first 24 hours postoperative
All patients will be provided with IV morphine PCA and morphine consumption within 24 hour postoperatively will be recorded for both groups.
7 secondary outcomes
Assessment of pain in postoperative period via visual analogue scales (VAS) .
Time frame: The first 24 hours postoperative
Total morphine demand
Time frame: During 24 hours postoperative
Time to first request for morphine
Time frame: During 24 hours postoperative
Requirement of rescue analgesia
Time frame: During 24 hours postoperative
Total intraoperative consumption of Fentanyl.
Time frame: Intraoperative period
Postoperative nausea and vomiting
Time frame: within 24 hours postoperative
Morphine related side effects
Time frame: During 24 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 24 Dec 2019.
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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.
Hayen Maghrebi, PROFESSOR study chair
UNIVERSITY OF TUNIS EL MANAR
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 spinae plane block in people with Breast Cancer Surgery and Postoperative Analgesia, run by Ben marzouk Sofiene at 1 site in Tunisia.
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 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2019. 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 Tunisia. 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. Some participants in this study may receive a placebo. 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?
Comparing morphine consumption rates within 24h postoperative (time frame: The first 24 hours postoperative). 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 24 Dec 2019.