Regional Anesthesia MorbidityNCT06260397
Serratus Anterior Plane Block and Costotransverse Block for Analgesia Following Modified Radical Mastectomy Surgeries
A study testing serratus anterior plane block and costotransverse block in people with Regional Anesthesia Morbidity, run by Ain Shams University at 1 site in Egypt.
Trial summary
Adequate pain management following modified radical mastectomy (MRM) is crucial for early ambulation and patient satisfaction. Breast cancer is the most common malignancy in females, with an increasing incidence in recent years. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Regional Anesthesia Morbidity
- What is being tested?
- serratus anterior plane block and costotransverse block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Dec 2023to 30 Mar 2025
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anaesthesiologists (ASA) Physical Status Class I, II.
- Scheduled for modified radical mastectomy (MRM).
- Body weight ranging from 60 to 100 kilograms.
Who cannot join
- Declining to give a written informed consent.
- History of allergy to the medications used in the study.
- Contraindications to regional anesthesia (including patient: refusal, coagulopathy, and local infection).
- Psychiatric disorders.
- Significant cognitive dysfunction.
- American Society of Anesthesiologists (ASA) Physical Status Class III and IV.
- Daily use of opioids.
- Obesity (BMI > 35 kg/m2).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
AinShamsU
Cairo, Abbasia, 154411
Fatma So Elsayed, MD, 01125186122, Dr.fatma_ebeid@yahoo.com
About this study
Official title: Ultrasound Guided Serratus Anterior Plane Block Versus Costotransverse Block on Postoperative Analgesia and Safety Following Modified Radical Mastectomy Surgeries
Adequate pain management following modified radical mastectomy (MRM) is crucial for early ambulation and patient satisfaction. Breast cancer is the most common malignancy in females, with an increasing incidence in recent years. Surgery is one of the mainstays of therapy for breast cancer, and modified radical mastectomy (MRM) is the most effective and common type of invasive surgical treatment. Post-mastectomy pain syndrome (PMPS) is a surgical complication of breast surgery characterized by chronic neuropathic pain. The aim of this study is to investigate the efficacy and safety of single injection CTB versus SAPB on post-operative acute pain as a part of a multimodal analgesia plan in patients undergoing MRM.
Read the detailed description
Patients will be divided randomly by the computer into three groups, group (A): will receive serratus anterior plane block, group (B): will receive costotransverse block and group(C): patient controlled analgesia group (PCA).
Group (A) (SAPB):
SAPB will be performed using an ultrasound machine with a high-frequency linear probe . All patients will be in lateral position to perform the block. At the level of the fourth rib with 45-degree angle, targeting the plane between the latissimus dorsi and serratus muscles, SAPB block will be performed unilaterally on the ipsilateral side of surgery.
Group (B) (CTB):
CTB will be performed using an ultrasound machine with a high-frequency linear probe. All patients will be in lateral position to perform the block. CTB block will be performed unilaterally on the ipsilateral side of surgery at the level of fourth rib.
Group (C) (patient controlled analgesia):
After successful extubation, patients will be transferred to PACU. Patients will receive a bolus dose of 5 mg nalbuphine then PCA pump in the form of 20 mg nalbuphine HCL in 100 ml 0.9% normal saline with basal rate of infusion 5ml/hr with self-administration bolus of 0.5ml with 15 min lock-out time.
- Conditions
- Regional Anesthesia Morbidity
- Being tested
- serratus anterior plane block, costotransverse block, patient controlled analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serratus anterior plane blockProcedure or surgery
using ultrasound, 30 ml of bupivacaine 0.25% will be injected in the plane between the latissimus dorsi and serratus muscles
costotransverse blockProcedure or surgery
using ultrasound, 30 ml of bupivacaine 0.25% will be injected in the costotransverse plane of fourth rib
patient controlled analgesiaProcedure or surgery
PCA pump in the form of 20 mg nalbuphine HCL in 100 ml 0.9% normal saline with basal rate of infusion 5ml/hr. with self-administration bolus of 0.5ml with 15 min lock-out time.
| Study group | Role | What they receive |
|---|---|---|
| serratus anterior plane block | Experimental | while the patients in lateral position, serratus anterior plane block will be done using high frequency linear ultrasound probe at the level of fourth rib.30 ml of 0.25% bupivacaine will be injected. Receives: Procedure: serratus anterior plane block |
| costotransverse plane block | Experimental | while the patients in lateral position, costotransverse block will be done using 22-gauge echogenic needle. the needle is advanced in-plane lateral to the spinous process of the 4th thoracic vertebra from caudally cephalad.30 ml of 0.25% bupivacaine will be injected Receives: Procedure: costotransverse block |
| patient controlled analgesia | Experimental | After successful extubation, patients will be transferred to PACU. Patients will receive a bolus dose of 5 mg nalbuphine then PCA pump in the form of 20 mg nalbuphine HCL in 100 ml 0.9% normal saline with basal rate of infusion 5ml/hr with self-administration bolus of 0.5ml with 15 min lock-out time. Receives: Procedure: patient controlled analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale score at 0,6,12 and 24 hour post-operatively. visual analogue scale is a scale from 0 to 10, 0 represent no pain at all and 10 represent the worst pain
Visual Analogue Scale score will be assessed at both rest and arm elevation
Measured: 24 hour post-operative
Secondary outcomes (2)
The total dose of nalbuphine consumption is used postoperatively per patient rescue analgesia for 24.
dose of nalbuphine consumed by patients
Measured: 24 hour post-operative
Incidence of chronic pain after 6 months of surgery
How many people develop chronic pain after surgery
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start28 Dec 2023
- Primary completion28 Feb 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Regional Anesthesia MorbidityStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260397
- Sponsor's protocol ID
- analgesia for MRM surgeries
- Status last verified
- Jan 2024
- First submitted
- 7 Feb 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhao Y, Jin W, Pan P, Feng S, Fu D, Yao J. Ultrasound-guided transversus thoracic muscle plane-pectoral nerve block for postoperative analgesia after modified radical mastectomy: a comparison with the thoracic paravertebral nerve block. Perioper Med (Lond). 2022 Jul 27;11(1):39. doi: 10.1186/s13741-022-00270-3.
PubMed 35883207Aygun H, Kiziloglu I, Ozturk NK, Ocal H, Inal A, Kutlucan L, Gonullu E, Tulgar S. Use of ultrasound guided single shot costotransverse block (intertransverse process) in breast cancer surgery: a prospective, randomized, assessor blinded, controlled clinical trial. BMC Anesthesiol. 2022 Apr 18;22(1):110. doi: 10.1186/s12871-022-01651-3.
PubMed 35436844Holm UHU, Andersen CHS, Hansen CK, Tanggaard K, Borglum J, Nielsen MV. Ultrasound-guided multiple-injection costotransverse block for mastectomy and primary reconstructive surgery. A study protocol. Acta Anaesthesiol Scand. 2022 Mar;66(3):386-391. doi: 10.1111/aas.14018. Epub 2022 Jan 5.
PubMed 34907523Jack JM, McLellan E, Versyck B, Englesakis MF, Chin KJ. The role of serratus anterior plane and pectoral nerves blocks in cardiac surgery, thoracic surgery and trauma: a qualitative systematic review. Anaesthesia. 2020 Oct;75(10):1372-1385. doi: 10.1111/anae.15000. Epub 2020 Feb 16.
PubMed 32062870Sahin A, Baran O, Gultekin A, Yildirim I, Arar C, Gunkaya M. Serratus anterior plane block for tertiary revision rhinoplasty with rib cartilage harvest. J Clin Anesth. 2021 Oct;73:110292. doi: 10.1016/j.jclinane.2021.110292. Epub 2021 Apr 29. No abstract available.
PubMed 33934036Ohgoshi Y, Usui Y, Ando A, Takeda Y, Ohtsuka A. Injection at the costotransverse notch facilitates paravertebral spread of the erector spinae plane block: A cadaveric study. J Clin Anesth. 2020 May;61:109630. doi: 10.1016/j.jclinane.2019.109630. Epub 2019 Oct 23. No abstract available.
PubMed 31668466Wang Y, Shi M, Huang S, He X, Gu X, Ma Z. Ultrasound-guided serratus anterior plane block versus paravertebral block on postoperation analgesia and safety following the video-assisted thoracic surgery: A prospective, randomized, double-blinded non-inferiority clinical trial. Asian J Surg. 2023 Oct;46(10):4215-4221. doi: 10.1016/j.asjsur.2022.11.125. Epub 2022 Dec 12.
PubMed 36517403
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Serratus Anterior Plane Block Versus Costotransverse Block on Postoperative Analgesia and Safety Following Modified Radical Mastectomy Surgeries
- ClinicalTrials.gov ID
- NCT06260397
- Acronym / sponsor ID
- analgesia for MRM surgeries
- Conditions
- Regional Anesthesia Morbidity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 28 Dec 2023 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 15 Feb 2024 (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.
Adequate pain management following modified radical mastectomy (MRM) is crucial for early ambulation and patient satisfaction. Breast cancer is the most common malignancy in females, with an increasing incidence in recent years. Surgery is one of the mainstays of therapy for breast cancer, and modified radical mastectomy (MRM) is the most effective and common type of invasive surgical treatment. Post-mastectomy pain syndrome (PMPS) is a surgical complication of breast surgery characterized by chronic neuropathic pain. The aim of this study is to investigate the efficacy and safety of single injection CTB versus SAPB on post-operative acute pain as a part of a multimodal analgesia plan in patients undergoing MRM.
Detailed description
Patients will be divided randomly by the computer into three groups, group (A): will receive serratus anterior plane block, group (B): will receive costotransverse block and group(C): patient controlled analgesia group (PCA).
Group (A) (SAPB):
SAPB will be performed using an ultrasound machine with a high-frequency linear probe . All patients will be in lateral position to perform the block. At the level of the fourth rib with 45-degree angle, targeting the plane between the latissimus dorsi and serratus muscles, SAPB block will be performed unilaterally on the ipsilateral side of surgery.
Group (B) (CTB):
CTB will be performed using an ultrasound machine with a high-frequency linear probe. All patients will be in lateral position to perform the block. CTB block will be performed unilaterally on the ipsilateral side of surgery at the level of fourth rib.
Group (C) (patient controlled analgesia):
After successful extubation, patients will be transferred to PACU. Patients will receive a bolus dose of 5 mg nalbuphine then PCA pump in the form of 20 mg nalbuphine HCL in 100 ml 0.9% normal saline with basal rate of infusion 5ml/hr with self-administration bolus of 0.5ml with 15 min lock-out time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| serratus anterior plane block | Experimental | Procedure: serratus anterior plane blockwhile the patients in lateral position, serratus anterior plane block will be done using high frequency linear ultrasound probe at the level of fourth rib.30 ml of 0.25% bupivacaine will be injected. |
| costotransverse plane block | Experimental | Procedure: costotransverse blockwhile the patients in lateral position, costotransverse block will be done using 22-gauge echogenic needle. the needle is advanced in-plane lateral to the spinous process of the 4th thoracic vertebra from caudally cephalad.30 ml of 0.25% bupivacaine will be injected |
| patient controlled analgesia | Experimental | Procedure: patient controlled analgesiaAfter successful extubation, patients will be transferred to PACU. Patients will receive a bolus dose of 5 mg nalbuphine then PCA pump in the form of 20 mg nalbuphine HCL in 100 ml 0.9% normal saline with basal rate of infusion 5ml/hr with self-administration bolus of 0.5ml with 15 min lock-out time. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anaesthesiologists (ASA) Physical Status Class I, II.
- Scheduled for modified radical mastectomy (MRM).
- Body weight ranging from 60 to 100 kilograms.
Key exclusion criteria (8 listed)
- Declining to give a written informed consent.
- History of allergy to the medications used in the study.
- Contraindications to regional anesthesia (including patient: refusal, coagulopathy, and local infection).
- Psychiatric disorders.
- Significant cognitive dysfunction.
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 blockusing ultrasound, 30 ml of bupivacaine 0.25% will be injected in the plane between the latissimus dorsi and serratus muscles | Procedure or surgery | serratus anterior plane block |
| costotransverse blockusing ultrasound, 30 ml of bupivacaine 0.25% will be injected in the costotransverse plane of fourth rib | Procedure or surgery | costotransverse plane block |
| patient controlled analgesiaPCA pump in the form of 20 mg nalbuphine HCL in 100 ml 0.9% normal saline with basal rate of infusion 5ml/hr. with self-administration bolus of 0.5ml with 15 min lock-out time. | Procedure or surgery | patient controlled analgesia |
Primary outcome
Visual Analogue Scale score at 0,6,12 and 24 hour post-operatively. visual analogue scale is a scale from 0 to 10, 0 represent no pain at all and 10 represent the worst pain
Time frame: 24 hour post-operative
Visual Analogue Scale score will be assessed at both rest and arm elevation
2 secondary outcomes
The total dose of nalbuphine consumption is used postoperatively per patient rescue analgesia for 24.
Time frame: 24 hour post-operative
Incidence of chronic pain after 6 months of surgery
Time frame: 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Background: PubMed 35883207Zhao Y, Jin W, Pan P, Feng S, Fu D, Yao J. Ultrasound-guided transversus thoracic muscle plane-pectoral nerve block for postoperative analgesia after modified radical mastectomy: a comparison with the thoracic paravertebral nerve block. Perioper Med (Lond). 2022 Jul 27;11(1):39. doi: 10.1186/s13741-022-00270-3.
- Background: PubMed 35436844Aygun H, Kiziloglu I, Ozturk NK, Ocal H, Inal A, Kutlucan L, Gonullu E, Tulgar S. Use of ultrasound guided single shot costotransverse block (intertransverse process) in breast cancer surgery: a prospective, randomized, assessor blinded, controlled clinical trial. BMC Anesthesiol. 2022 Apr 18;22(1):110. doi: 10.1186/s12871-022-01651-3.
- Background: PubMed 34907523Holm UHU, Andersen CHS, Hansen CK, Tanggaard K, Borglum J, Nielsen MV. Ultrasound-guided multiple-injection costotransverse block for mastectomy and primary reconstructive surgery. A study protocol. Acta Anaesthesiol Scand. 2022 Mar;66(3):386-391. doi: 10.1111/aas.14018. Epub 2022 Jan 5.
- Background: PubMed 32062870Jack JM, McLellan E, Versyck B, Englesakis MF, Chin KJ. The role of serratus anterior plane and pectoral nerves blocks in cardiac surgery, thoracic surgery and trauma: a qualitative systematic review. Anaesthesia. 2020 Oct;75(10):1372-1385. doi: 10.1111/anae.15000. Epub 2020 Feb 16.
- Background: PubMed 33934036Sahin A, Baran O, Gultekin A, Yildirim I, Arar C, Gunkaya M. Serratus anterior plane block for tertiary revision rhinoplasty with rib cartilage harvest. J Clin Anesth. 2021 Oct;73:110292. doi: 10.1016/j.jclinane.2021.110292. Epub 2021 Apr 29. No abstract available.
- Background: PubMed 31668466Ohgoshi Y, Usui Y, Ando A, Takeda Y, Ohtsuka A. Injection at the costotransverse notch facilitates paravertebral spread of the erector spinae plane block: A cadaveric study. J Clin Anesth. 2020 May;61:109630. doi: 10.1016/j.jclinane.2019.109630. Epub 2019 Oct 23. No abstract available.
- Background: PubMed 36517403Wang Y, Shi M, Huang S, He X, Gu X, Ma Z. Ultrasound-guided serratus anterior plane block versus paravertebral block on postoperation analgesia and safety following the video-assisted thoracic surgery: A prospective, randomized, double-blinded non-inferiority clinical trial. Asian J Surg. 2023 Oct;46(10):4215-4221. doi: 10.1016/j.asjsur.2022.11.125. Epub 2022 Dec 12.
- 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.
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 and costotransverse block in people with Regional Anesthesia Morbidity, run by Ain Shams 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 3 inclusion and 8 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 11 Dec 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 Abdalla Ma Abdalla, master (00201006717445 ext. 002, abdalla.magdy@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale score at 0,6,12 and 24 hour post-operatively. visual analogue scale is a scale from 0 to 10, 0 represent no pain at all and 10 represent the worst pain (time frame: 24 hour post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06260397, which also lists 7 linked publications.
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 11 Dec 2024.