Patients Undergoing Modified Radical MastectomyNCT05352282
Comparative Study Between the Efficacy of The Serratus Anterior Plane Block and Lumbar Intrathecal Fentanyl Injection for Postoperative Analgesia After Modified Radical Mastectomy
A study testing Serratus Anterior Plane Block and Lumbar Intrathecal Fentanyl Injection in people with Patients Undergoing Modified Radical Mastectomy, run by Sohag University at 1 site in Egypt.
Trial summary
Modified radical mastectomy (MRM) is one of the most common surgeries performed, and one that may be associated with significant acute postoperative pain in breast surgery. Acute postoperative pain is an independent risk factor in the development of chronic post-mastectomy pain . Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Patients Undergoing Modified Radical Mastectomy
- What is being tested?
- Serratus Anterior Plane Block and Lumbar Intrathecal Fentanyl Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 1 Feb 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 50 patients with American Society of Anesthesiologists (ASA) grade I to II, 18 to 60 years of age scheduled for Modified Radical Mastectomy surgery
Who cannot join
- Patient refusal.
- Patient with significant neurological , psychiatric or neuromuscular disease
- Alcoholism .
- Drug abuse .
- Pregnancy or lactating women .
- Suspected Coagulopathy .
Show all 9Show fewer
- Morbid obesity .
- Known allergy to study medications .
- Septicaemia and local infection at the block site.
Trial locations and contacts
1 site in 1 country.
About this study
Modified radical mastectomy (MRM) is one of the most common surgeries performed, and one that may be associated with significant acute postoperative pain in breast surgery. Acute postoperative pain is an independent risk factor in the development of chronic post-mastectomy pain .
Various regional anesthetic procedures have been tried to provide better acute pain control and, consequently, less chronic pain. They can reduce perioperative opiates requirement and thereby decreasing their possible side effects. These regional procedures include local wound infiltration, lumbar intrathecal fentanyl injection, thoracic epidural, thoracic paravertebral block (PVB), and ultrasound (US)-guided interfascial plane blocks. Currently, Ultrasound (US)-guided interfascial plane blocks have been recommended as safe, easy, and reliable alternatives to the use of thoracic epidural and paravertebral blocks in providing analgesia for patients about to undergo breast surgery.
Read more
Serratus anterior plane block (SAPB) is one of the Ultrasound (US)-guided interfascial plane blocks, it blocks the intercostal nerves II-VI by injection above or below the serratus muscle in the mid-axillary line and spares the pectoral nerves.
We assumed that SAPB could safely provide a better analgesic profile with an opioid-sparing effect than Intrathecal fentanyl. We will perform this study to evaluate this assumption.
- Being tested
- Serratus Anterior Plane Block, Lumbar Intrathecal Fentanyl Injection
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
SAPB will be done preoperative before induction of anesthesia under songraphic guidance and aseptic conditions with the patient in the lateral position, with the side of the surgical side up and the upper limb hanging over the patient's head. The ribs will be then counted, and when the 5th rib is identified, the high-frequency probe will be put over it, in the mid-axillary line in a sagittal plane. The ribs, pleura, overlying serratus muscle and latissimus dorsi muscle will be identified, and the needle will be advanced cephalic in-plane until the tip reaches the plane between the serratus anterior and latissimus dorsi. Afterward, 2 mL dextrose 5% will be injected; then, 30 mL of bupivacaine 0.25% will be injected in the plane between the serratus anterior and latissimus dorsi.
Lumbar Intrathecal Fentanyl InjectionProcedure or surgery
Patients will receive 25 microgram intracthecal fentanyl immediately preoperative.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Not described Receives: Procedure: Serratus Anterior Plane Block |
| Group B | Active comparator | Not described Receives: Procedure: Lumbar Intrathecal Fentanyl Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
analgesic effect of serratus anterior plane block and lumbar intrathecal fentanyl injection after modified radical mastectomy
compare the analgesic effect between serratus anterior plane block and lumbar intrathecal fentanyl injection by using visual analogue score (vas).
-Postoperative pain will be assessed using visual analog score (VAS) [0-10]. 0 - 3 mild pain 4 - 6 moderate pain 7 - 10 severe pain 10 <unbearable pain)
Measured: 1 year
Secondary outcomes (2)
Hemodynamics effects of serratus anterior plane block and lumbar intrathecal fentanyl injection in patient undergoing modified radical mastectomy
compare between serratus anterior plane block and lumbar intrathecal fentanyl injection as regard, hemodynamics of patient undergoing modified radical mastectomy.
-The heart rate (HR), noninvasive arterial systolic blood pressure (SBP), diastolic blood pressure (DBP) and peripheral oxygen saturation (SpO2) will be recorded at baseline, after induction and with skin incision and every 5 minutes intraoperative till the end of surgery. And postoperative at 30 min, 1, 2, 3, 6, 12 and 24 hours.
Measured: 1 year
Intra venous analgesics consumption after serratus anterior plane block and lumbar intrathecal fentanyl injection in patient undergoing modified radical mastectomy
compare between serratus anterior plane block and lumbar intrathecal fentanyl injection in patient undergoing modified radical mastectomy as regard intra venous analgesics consumption.
All patients will receive paracetamol (15mg/KG/dose) immediately postoperative and after 6 hours. Patients will be assessed every one hour in the first 6 hours then every 3 hours in the next 18 hours.
Patients will receive ketorolac 30 mg if VAS 3-5 . If VAS>5 ,morphine 0.1mg/kg will be given then total ketorolac and morphine consumption in 24 hours will be calculated and compared between both groups .
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 Apr 2022
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Patients Undergoing Modified Radical MastectomyStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Nozahy, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352282
- Sponsor's protocol ID
- Soh-Med-22_03_02
- Status last verified
- Feb 2023
- First submitted
- 17 Apr 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Amaya F, Hosokawa T, Okamoto A, Matsuda M, Yamaguchi Y, Yamakita S, Taguchi T, Sawa T. Can acute pain treatment reduce postsurgical comorbidity after breast cancer surgery? A literature review. Biomed Res Int. 2015;2015:641508. doi: 10.1155/2015/641508. Epub 2015 Oct 1.
PubMed 26495309Wang L, Guyatt GH, Kennedy SA, Romerosa B, Kwon HY, Kaushal A, Chang Y, Craigie S, de Almeida CPB, Couban RJ, Parascandalo SR, Izhar Z, Reid S, Khan JS, McGillion M, Busse JW. Predictors of persistent pain after breast cancer surgery: a systematic review and meta-analysis of observational studies. CMAJ. 2016 Oct 4;188(14):E352-E361. doi: 10.1503/cmaj.151276. Epub 2016 Jul 11.
PubMed 27402075Garg R, Bhan S, Vig S. Newer regional analgesia interventions (fascial plane blocks) for breast surgeries: Review of literature. Indian J Anaesth. 2018 Apr;62(4):254-262. doi: 10.4103/ija.IJA_46_18.
PubMed 29720750Garg R. Regional anaesthesia in breast cancer: Benefits beyond pain. Indian J Anaesth. 2017 May;61(5):369-372. doi: 10.4103/ija.IJA_292_17. No abstract available.
PubMed 28584344
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between the Efficacy of The Serratus Anterior Plane Block and Lumbar Intrathecal Fentanyl Injection for Postoperative Analgesia After Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT05352282
- Acronym / sponsor ID
- Soh-Med-22_03_02
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 28 Apr 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.
Modified radical mastectomy (MRM) is one of the most common surgeries performed, and one that may be associated with significant acute postoperative pain in breast surgery. Acute postoperative pain is an independent risk factor in the development of chronic post-mastectomy pain .
Various regional anesthetic procedures have been tried to provide better acute pain control and, consequently, less chronic pain. They can reduce perioperative opiates requirement and thereby decreasing their possible side effects. These regional procedures include local wound infiltration, lumbar intrathecal fentanyl injection, thoracic epidural, thoracic paravertebral block (PVB), and ultrasound (US)-guided interfascial plane blocks. Currently, Ultrasound (US)-guided interfascial plane blocks have been recommended as safe, easy, and reliable alternatives to the use of thoracic epidural and paravertebral blocks in providing analgesia for patients about to undergo breast surgery.
Serratus anterior plane block (SAPB) is one of the Ultrasound (US)-guided interfascial plane blocks, it blocks the intercostal nerves II-VI by injection above or below the serratus muscle in the mid-axillary line and spares the pectoral nerves.
We assumed that SAPB could safely provide a better analgesic profile with an opioid-sparing effect than Intrathecal fentanyl. We will perform this study to evaluate this assumption.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Serratus Anterior Plane Block |
| Group B | Active comparator | Procedure: Lumbar Intrathecal Fentanyl Injection |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 50 patients with American Society of Anesthesiologists (ASA) grade I to II, 18 to 60 years of age scheduled for Modified Radical Mastectomy surgery
Key exclusion criteria (9 listed)
- Patient refusal.
- Patient with significant neurological , psychiatric or neuromuscular disease
- Alcoholism .
- Drug abuse .
- Pregnancy or lactating women .
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 BlockSAPB will be done preoperative before induction of anesthesia under songraphic guidance and aseptic conditions with the patient in the lateral position, with the side of the surgical side up and the upper limb hanging over the patient's head. The ribs will be then counted, and when the 5th rib is identified, the high-frequency probe will be put over it, in the mid-axillary line in a sagittal plane. The ribs, pleura, overlying serratus muscle and latissimus dorsi muscle will be identified, and the needle will be advanced cephalic in-plane until the tip reaches the plane between the serratus anterior and latissimus dorsi. Afterward, 2 mL dextrose 5% will be injected; then, 30 mL of bupivacaine 0.25% will be injected in the plane between the serratus anterior and latissimus dorsi. | Procedure or surgery | Group A |
| Lumbar Intrathecal Fentanyl InjectionPatients will receive 25 microgram intracthecal fentanyl immediately preoperative. | Procedure or surgery | Group B |
Primary outcome
analgesic effect of serratus anterior plane block and lumbar intrathecal fentanyl injection after modified radical mastectomy
Time frame: 1 year
compare the analgesic effect between serratus anterior plane block and lumbar intrathecal fentanyl injection by using visual analogue score (vas). -Postoperative pain will be assessed using visual analog score (VAS) [0-10]. 0 - 3 mild pain 4 - 6 moderate pain 7 - 10 severe pain 10 <unbearable pain)
2 secondary outcomes
Hemodynamics effects of serratus anterior plane block and lumbar intrathecal fentanyl injection in patient undergoing modified radical mastectomy
Time frame: 1 year
Intra venous analgesics consumption after serratus anterior plane block and lumbar intrathecal fentanyl injection in patient undergoing modified radical mastectomy
Time frame: one year
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 8 Feb 2023.
- Background: PubMed 26495309Amaya F, Hosokawa T, Okamoto A, Matsuda M, Yamaguchi Y, Yamakita S, Taguchi T, Sawa T. Can acute pain treatment reduce postsurgical comorbidity after breast cancer surgery? A literature review. Biomed Res Int. 2015;2015:641508. doi: 10.1155/2015/641508. Epub 2015 Oct 1.
- Background: PubMed 27402075Wang L, Guyatt GH, Kennedy SA, Romerosa B, Kwon HY, Kaushal A, Chang Y, Craigie S, de Almeida CPB, Couban RJ, Parascandalo SR, Izhar Z, Reid S, Khan JS, McGillion M, Busse JW. Predictors of persistent pain after breast cancer surgery: a systematic review and meta-analysis of observational studies. CMAJ. 2016 Oct 4;188(14):E352-E361. doi: 10.1503/cmaj.151276. Epub 2016 Jul 11.
- Background: PubMed 29720750Garg R, Bhan S, Vig S. Newer regional analgesia interventions (fascial plane blocks) for breast surgeries: Review of literature. Indian J Anaesth. 2018 Apr;62(4):254-262. doi: 10.4103/ija.IJA_46_18.
- Background: PubMed 28584344Garg R. Regional anaesthesia in breast cancer: Benefits beyond pain. Indian J Anaesth. 2017 May;61(5):369-372. doi: 10.4103/ija.IJA_292_17. No abstract available.
- Individual participant dataSharing planned: Undecided
Related trials for Patients Undergoing Modified Radical Mastectomy
Not yet recruiting
Trial Evaluating the Analgesic Efficacy of Magnesium Sulfate as an Adjuvant to Bupivacaine in Local Wound Infiltration for Patients Undergoing Modified Radical Mastectomy (MRM) With Axillary Clearance
Modified Radical Mastectomy
Enrolling by invitation
Efficacy of Tramadol With Ropivacaine for Modified Pectoral Nerve Block in Breast Cancer Surgery
Postoperative Pain
Not yet recruiting
Adding Magnesium Sulfate to Combined Pecto-Intercostal & Serratus Anterior Planes Block on Post-operative Analgesia in Patients Undergoing Modified Radical Mastectomy
Modified Radical Mastectomy
Enrolling by invitation
Serratus Posterior Superior Intercostal Plane Block, Versus Erector Spinae Facial Plane Blocks
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Recruiting
Comparing Between Ultrasound Guided Pectoral Nerve Block Versus Ultrasound Guided Mid-point Transverse Process Block for Postoperative Analgesia in Patients Undergoing Modified Radical Mastectomy
Post Operative Pain
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 study testing Serratus Anterior Plane Block and Lumbar Intrathecal Fentanyl Injection in people with Patients Undergoing Modified Radical Mastectomy, run by Sohag 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 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 8 Feb 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.
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?
analgesic effect of serratus anterior plane block and lumbar intrathecal fentanyl injection after modified radical mastectomy (time frame: 1 year). 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 NCT05352282, which also lists 4 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 8 Feb 2023.