Breast NeoplasmsUSB22NCT05494281
Serratus Anterior Plane Block to Prevent Chronic Postoperative Pain in Breast Cancer
A study testing Serratus Anterior Plane Block with local anesthetic and Serratus Anterior Plane Block with saline solution in people with Breast Neoplasms and Pain, Postoperative, run by Moroccan Society of Surgery at 1 site in Morocco.
Trial summary
Chronic postoperative pain (CPP) remains a disturbing and obscure clinical problem. The hypothesis of this trial is that a peripheral block of the serratus anterior plane block type preoperatively after a modified radical mastectomy makes it possible to reduce the intensity and incidence of chronic post-surgical pain… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasms, Pain, Postoperative, Pain, Chronic
- What is being tested?
- Serratus Anterior Plane Block with local anesthetic and Serratus Anterior Plane Block with saline solution
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteMorocco
- Study dates
- 1 Aug 2022to 31 Jul 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having an age greater than or equal to 18 years and less than 70 years
- Having given written consent for participation in the study and the use of personal and medical data
- Having a physical status of class I, II or III of the American Society of Anesthesiologists
Who cannot join
- Patients who expressed their refusal to participate in the study
- Patients unable to express their non-objection to participation in the study
- American Society of Anesthesiologists class > III patients
- Known allergy to local anesthetics
- A contraindication to performing a peripheral nerve block (such as an acquired, constitutional or drug clotting disorder or infection at the nerve block injection site)
- Morbid obesity (body mass index greater than 40 kg/m²)
Show all 11Show fewer
- Chronic use of opioids
- Inability to use the patient controlled analgesia device
- The existence of preoperative pain
- History of neuropathy or neurological pathology
- The existence of catastrophism or anxiety diagnosed preoperatively
Trial locations and contacts
1 site in 1 country.
Morocco1 site, 1 recruiting
- Recruiting
Anesthesia & Critical care department - National Institut of Oncology in Rabat. Ibn Sina teaching Hospital. Mohammed V university of Rabat
Rabat, 10100
Abdelilah GHANNAM, MD, +212661382585, a.ghannam@um5r.ac.ma
About this study
Official title: Serratus Anterior Plane Block to Prevent Chronic Pain in Breast Cancer Surgery: A Randomized Controlled Trial
Chronic postoperative pain (CPP) remains a disturbing and obscure clinical problem.
The hypothesis of this trial is that a peripheral block of the serratus anterior plane block type preoperatively after a modified radical mastectomy makes it possible to reduce the intensity and incidence of chronic post-surgical pain in breast cancer.
- Conditions
- Breast Neoplasms, Pain, Postoperative, Pain, Chronic, Post-Mastectomy Chronic Pain Syndrome
- Being tested
- Serratus Anterior Plane Block with local anesthetic, Serratus Anterior Plane Block with saline solution
- Medical subject headings
- Breast Neoplasms, Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus Anterior Plane Block with local anestheticProcedure or surgery
A deep analgesic block of the Serratus anterior plane block (SAPB) type by echo-guided lateral approach will be performed by An 8-13 Mhz high frequency linear ultrasound probe witch will be located cranio-caudally, transversely to the 3rd and 4th intercostal space on the mid-axillary line while patients are supine with the ipsilateral upper limb raised to 90°.
Once the landmark anatomical structures have been identified (upper rib, lower rib, pleural line, Serratus muscle, superficial structures), the puncture will begin Under aseptic conditions, an 80 mm 22 gauge needle will be inserted into the "in-plane" view of the ultrasound probe. When the needle has reached the plane under Serratus between the Serratus muscle and the intercostal muscle opposite the lower edge of the upper rib, 30 ml of 1% Lidocaine will be administered.
Serratus Anterior Plane Block with saline solutionProcedure or surgery
A deep analgesic block of the Serratus anterior plane block (SAPB) type by echo-guided lateral approach will be performed by An 8-13 Mhz high frequency linear ultrasound probe witch will be located cranio-caudally, transversely to the 3rd and 4th intercostal space on the mid-axillary line while patients are supine with the ipsilateral upper limb raised to 90°.
Once the landmark anatomical structures have been identified (upper rib, lower rib, pleural line, Serratus muscle, superficial structures), the puncture will begin Under aseptic conditions, an 80 mm 22 gauge needle will be inserted into the "in-plane" view of the ultrasound probe. When the needle has reached the plane under Serratus between the Serratus muscle and the intercostal muscle opposite the lower edge of the upper rib, 30 ml of saline solution
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | Not described Receives: Procedure: Serratus Anterior Plane Block with saline solution |
| Serratus anterior plane block | Experimental | Not described Receives: Procedure: Serratus Anterior Plane Block with local anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic postoperative pain at 3 months
A question will be asked to patients : "Throughout our lives, most have had pain (like headaches, sprains and toothaches). Have you had pain other than these types of pain on a daily basis since your surgery? " The answer "yes" or "no" will determine the outcome
Measured: 3 months after surgery
chronic postoperative pain intensity
Pain intensity of patients was evaluated by Numerical Rating Scale, rating from 0 (no pain) to 10 (extreme pain) in order to evaluate the effect of Serratus Anterior Plane Block in preventing chronic pain
Measured: 3 months after surgery
Secondary outcomes (3)
Chronic Pain intensity and quality
Pain intensity of patients was evaluated by Arabic version of Brief pain inventory
Measured: 3 months after surgery
Neuropathic pain screening
Neuropathic pain will be screened by "Douleur Neuropathique 4" score
Measured: 3 months after surgery
Morphine consumption
Morphine rescue dose for extra need of analgesic
Measured: 0-24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start1 Aug 2022
- Primary completion1 Feb 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moroccan Society of Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdelilah GHANNAM, MD, Study director, Mohammed V University in Rabat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494281
- Sponsor's protocol ID
- USB_22 Trial
- Acronym
- USB22
- Status last verified
- Sep 2022
- First submitted
- 6 Aug 2022
- Last updated
- 22 Sep 2022
- 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 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serratus Anterior Plane Block to Prevent Chronic Pain in Breast Cancer Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05494281
- Acronym / sponsor ID
- USB22 / USB_22 Trial
- Conditions
- Breast Neoplasms, Pain, Postoperative, Pain, Chronic, Post-Mastectomy Chronic Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Moroccan Society of SurgeryUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 9 Aug 2022 (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.
Chronic postoperative pain (CPP) remains a disturbing and obscure clinical problem.
The hypothesis of this trial is that a peripheral block of the serratus anterior plane block type preoperatively after a modified radical mastectomy makes it possible to reduce the intensity and incidence of chronic post-surgical pain in breast cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Procedure: Serratus Anterior Plane Block with saline solution |
| Serratus anterior plane block | Experimental | Procedure: Serratus Anterior Plane Block with local anesthetic |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having an age greater than or equal to 18 years and less than 70 years
- Having given written consent for participation in the study and the use of personal and medical data
- Having a physical status of class I, II or III of the American Society of Anesthesiologists
Key exclusion criteria (11 listed)
- Patients who expressed their refusal to participate in the study
- Patients unable to express their non-objection to participation in the study
- American Society of Anesthesiologists class > III patients
- Known allergy to local anesthetics
- A contraindication to performing a peripheral nerve block (such as an acquired, constitutional or drug clotting disorder or infection at the nerve block injection site)
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 |
|---|---|---|
| Serratus Anterior Plane Block with local anestheticA deep analgesic block of the Serratus anterior plane block (SAPB) type by echo-guided lateral approach will be performed by An 8-13 Mhz high frequency linear ultrasound probe witch will be located cranio-caudally, transversely to the 3rd and 4th intercostal space on the mid-axillary line while patients are supine with the ipsilateral upper limb raised to 90°. Once the landmark anatomical structures have been identified (upper rib, lower rib, pleural line, Serratus muscle, superficial structures), the puncture will begin Under aseptic conditions, an 80 mm 22 gauge needle will be inserted into the "in-plane" view of the ultrasound probe. When the needle has reached the plane under Serratus between the Serratus muscle and the intercostal muscle opposite the lower edge of the upper rib, 30 ml of 1% Lidocaine will be administered. | Procedure or surgery | Serratus anterior plane block |
| Serratus Anterior Plane Block with saline solutionA deep analgesic block of the Serratus anterior plane block (SAPB) type by echo-guided lateral approach will be performed by An 8-13 Mhz high frequency linear ultrasound probe witch will be located cranio-caudally, transversely to the 3rd and 4th intercostal space on the mid-axillary line while patients are supine with the ipsilateral upper limb raised to 90°. Once the landmark anatomical structures have been identified (upper rib, lower rib, pleural line, Serratus muscle, superficial structures), the puncture will begin Under aseptic conditions, an 80 mm 22 gauge needle will be inserted into the "in-plane" view of the ultrasound probe. When the needle has reached the plane under Serratus between the Serratus muscle and the intercostal muscle opposite the lower edge of the upper rib, 30 ml of saline solution | Procedure or surgery | Placebo |
Primary outcome
Chronic postoperative pain at 3 months
Time frame: 3 months after surgery
A question will be asked to patients : "Throughout our lives, most have had pain (like headaches, sprains and toothaches). Have you had pain other than these types of pain on a daily basis since your surgery? " The answer "yes" or "no" will determine the outcome
chronic postoperative pain intensity
Time frame: 3 months after surgery
Pain intensity of patients was evaluated by Numerical Rating Scale, rating from 0 (no pain) to 10 (extreme pain) in order to evaluate the effect of Serratus Anterior Plane Block in preventing chronic pain
3 secondary outcomes
Chronic Pain intensity and quality
Time frame: 3 months after surgery
Neuropathic pain screening
Time frame: 3 months after surgery
Morphine consumption
Time frame: 0-24 hours after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- 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.
Abdelilah GHANNAM, MD study director
Mohammed V University in Rabat
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serratus Anterior Plane Block with local anesthetic and Serratus Anterior Plane Block with saline solution in people with Breast Neoplasms and Pain, Postoperative, run by Moroccan Society of Surgery at 1 site in Morocco.
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 11 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 22 Sep 2022. 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 Morocco. 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 Abdelilah GHANNAM, MD (+212661382585, a.ghannam@um5r.ac.ma), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic postoperative pain at 3 months (time frame: 3 months after surgery). The study lists 2 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 22 Sep 2022.