Pain ManagementNCT07247448

The Analgesic Efficacy of Pecto-Intercostal Fascial Block Combined With Pectoral Nerve Block II Versus Serratus Plane Block in Modified Radical Mastectomy

A study testing PECS II block, SAPB block and PIFB in people with Pain Management, run by Assiut University at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

The goal of this clinical trial is to to evaluate the analgesic efficacy of PECS II-PIFB versus SAPB for 24 hours in women aged from 18 to 65 years and scheduled for MRM. The main question it aims to answer is: which nerve block is better regarding the total analgesic consumption and the lowest postoperative… Read more about this study

Who is it for?: Ages 18 to 65 years, women only
Conditions the study is for: Pain Management
What is being tested?: PECS II block, SAPB block and PIFB
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteEgypt
Study dates: 15 Oct 2025to Nov 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

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 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients scheduled for elective MRM
Age 18-65 years
American Society of Anesthesiologists (ASA) physical state I-II

Who cannot join

Patient refusal.
Body Mass Index > 30 kg/m2.
Skin infection at the site of injection.
History of renal, liver, cardiac, and neuropsychiatric disorder problems.
Bleeding or coagulation abnormality.
Known allergy to any drugs used in this study.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Assiut University
Asyut

Other trials in Egypt

About this study

Conditions: Pain Management
Being tested: PECS II block, SAPB block, PIFB
Medical subject headings: Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PECS II blockProcedure or surgery
Ultrasound-Guided PECS II Block With the patient in a supine position, her arm in a neutral position, and under complete aseptic technique, a 6 to 13 MHz ultrasound linear transducer probe (Mindray, Shen zhen, China) will be positioned below the distal one-third of the clavicle to visualize the pectoralis major and minor muscles, SAM, pectoral branch of the thoracoacromial artery, the second and third ribs, and the external intercostal muscles between the ribs. The needle will be inserted in-plane in a medial-to-lateral direction until its tip is placed between the SAM and the external intercostal muscles. The first injection will be done below the SAM using 20 mL bupivacaine 0.25% at the level of the second rib to block the intercostobrachial nerves and the lateral branches of the third to the sixth intercostal nerves. The needle will be withdrawn until its tip is placed between the pectoralis major and minor muscles, and an additional 10 mL of bupivacaine 0.25% will be injected.
SAPB blockProcedure or surgery
Ultrasound-Guided Serratus Anterior Plane Block (SAPB) The probe will be placed on the mid-axillary line at the level of the fourth rib to visualize the serratus anterior and latissimus dorsi muscles. After establishing the correct level, the needle will be introduced in-plane. After puncturing the serratus muscle and contacting the rib, 40 mL of bupivacaine 0.25% will be deposited between the serratus muscle fascia and the rib periosteum, termed a deep serratus anterior plane block.
PIFBProcedure or surgery
Ultrasound-Guided PIFB Under complete aseptic technique with the patient in the supine position, a 6 to 13 MHz ultrasound linear transducer probe (Mindray, Shen zhen, China) will be placed 2 or 3 cm parallel to the long axis of the sternal bone to identify the second to fourth costal cartilages and targeting the fourth costal cartilage The needle will be inserted in-plane with the US probe, in a caudal-to-cranial direction. The needle will be advanced until the tip is positioned in the interfascial plane between the pectoralis major muscle and the intercostal muscle. After confirmation of the correct position of the tip of the needle, as shown by separation of the fascial layers on injecting 2 mL normal saline solution, 10 mL of bupivacaine 0.25% will be injected.

Study groups in NCT07247448
Study group	Role	What they receive
PIFB-PECS II	Active comparator	Not described Receives: Procedure: PECS II block; Procedure: PIFB
SAPB	Active comparator	Not described Receives: Procedure: SAPB block

What is being measured

The primary outcome is the main question the study is designed to answer.

The analgesic efficacy of PECS II-PIFB versus SAPB in patients scheduled for MRM by the total analgesic consumption (nalbuphine in mg) during the first 24 hours.
The analgesic efficacy of PECS II-PIFB versus SAPB in patients scheduled for MRM by the total analgesic consumption (nalbuphine in mg) during the first 24 hours.
Measured: 24 hours

Secondary outcomes (1)

Post operative Pain Scores
postoperatively, the numeric rating scale (NRS) for pain assessment during rest and ipsilateral arm movement
Measured: 30 minutes, 1hours, 2hours, 4hours, 6hours, 8hours, 12hours and 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 2025Nov 2026

First posted25 Nov 2025
Study start15 Oct 2025
Primary completionNov 2026 (estimated)
Study completionNov 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (24)Papers the sponsor has linked to this study.
Other trials for Pain ManagementStudies of the same condition, open and under way.
More trials run by Assiut 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
Model description: Patients: 70 patients will be enrolled in this study. They will be equally divided into two groups: Group A (PIFB-PECS II): 35 patients will receive 40 mL of 0.25% bupivacaine. * PECS II block divided into 2 injections. 1. 10 ml between the pectoralis major and pectoralis minor 2. 20 ml between the pectoralis minor and stratus anterior muscle * PIFB 10 mL between the pectoralis major and the intercostal muscle. Group B (Serratus plane block): 35 patients will receive 40 mL of 0. 25% bupivacaine.
Masking: None (open label)
Enrolment: 70 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07247448
Sponsor's protocol ID: PECB II & PIFB VS SAPB in MRM
Status last verified: Nov 2025
First submitted: 17 Nov 2025
Last updated: 2 Dec 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified individual participant data (IPD) underlying the results of this study will be made available to researchers upon reasonable request from the corresponding author after the publication of results, for a period of one year. The shared data will include anonymized variables relevant to the primary and secondary outcomes

Publications

Patel LP, Sanghvi PR, Agarwal MB, Prajapati GC, Patel BM. Thoracic paravertebral block for analgesia after modified radical mastectomy. Indian J Pain 2014;28:160-165.
Misbah Mahmoud A., Said Ahmed A., Aly Salah A., Ahmed El-sayed N., Ali El Asser H., Mohamed Elsaed M. Ketamine Versus Dexmedetomidine as Adjuvants to Bupivacaine in Modified Pectoralis Plane Block for Analgesia in Patients Undergoing Modified Radical Mastectomy. Zagazig Univ Med J 2025.
Jamieson S. Likert scales: how to (ab)use them. Med Educ. 2004 Dec;38(12):1217-8. doi: 10.1111/j.1365-2929.2004.02012.x. No abstract available.
PubMed 15566531
Karcioglu O, Topacoglu H, Dikme O, Dikme O. A systematic review of the pain scales in adults: Which to use? Am J Emerg Med. 2018 Apr;36(4):707-714. doi: 10.1016/j.ajem.2018.01.008. Epub 2018 Jan 6.
PubMed 29321111
Hu NQ, He QQ, Qian L, Zhu JH. Efficacy of Ultrasound-Guided Serratus Anterior Plane Block for Postoperative Analgesia in Patients Undergoing Breast Surgery: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. Pain Res Manag. 2021 Oct 25;2021:7849623. doi: 10.1155/2021/7849623. eCollection 2021.
PubMed 34733377
Hozien AI, Helmy AM, Koptan HM, Elfeil YE, Yakout MMS, Elwafa HBAA. Analgesic Effect of Addition of Pectointercostal Block to Serratus Anterior Plane Block in Breast Surgeries: A Randomized, Controlled Trial. Pain Physician. 2023 Oct;26(6):E679-E685.
PubMed 37847921
Jayadeep I, Srinivasan G, Sethuramachandran A, Elakkumanan LB, Swaminathan S, Bidkar P. Comparison of the Analgesic Efficacy of Ultrasound-Guided Superficial Serratus Anterior Plane Block With Deep Serratus Anterior Plane Block in Patients Undergoing Modified Radical Mastectomy: A Randomized Clinical Trial. Cureus. 2022 Oct 29;14(10):e30828. doi: 10.7759/cureus.30828. eCollection 2022 Oct.
PubMed 36451631
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343
Woodworth GE, Ivie RMJ, Nelson SM, Walker CM, Maniker RB. Perioperative Breast Analgesia: A Qualitative Review of Anatomy and Regional Techniques. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):609-631. doi: 10.1097/AAP.0000000000000641.
PubMed 28820803
Hong B, Yoon SH, Youn AM, Kim BJ, Song S, Yoon Y. Thoracic interfascial nerve block for breast surgery in a pregnant woman: a case report. Korean J Anesthesiol. 2017 Apr;70(2):209-212. doi: 10.4097/kjae.2017.70.2.209. Epub 2017 Jan 12.
PubMed 28367293
Lopez-Matamala B, Fajardo M, Estebanez-Montiel B, Blancas R, Alfaro P, Chana M. A new thoracic interfascial plane block as anesthesia for difficult weaning due to ribcage pain in critically ill patients. Med Intensiva. 2014 Oct;38(7):463-5. doi: 10.1016/j.medin.2013.10.005. Epub 2013 Nov 26. No abstract available.
PubMed 24289954
de la Torre PA, Garcia PD, Alvarez SL, Miguel FJ, Perez MF. A novel ultrasound-guided block: a promising alternative for breast analgesia. Aesthet Surg J. 2014 Jan 1;34(1):198-200. doi: 10.1177/1090820X13515902. No abstract available.
PubMed 24396082
Wijayasinghe N, Andersen KG, Kehlet H. Analgesic and Sensory Effects of the Pecs Local Anesthetic Block in Patients with Persistent Pain after Breast Cancer Surgery: A Pilot Study. Pain Pract. 2017 Feb;17(2):185-191. doi: 10.1111/papr.12423. Epub 2016 Feb 9.
PubMed 26857336
Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.
PubMed 25376971
Perez MF, Duany O, de la Torre PA. Redefining PECS Blocks for Postmastectomy Analgesia. Reg Anesth Pain Med. 2015 Nov-Dec;40(6):729-30. doi: 10.1097/AAP.0000000000000243. No abstract available.
PubMed 26488081

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pain Management trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Analgesic Efficacy of Pecto-Intercostal Fascial Block Combined With Pectoral Nerve Block II Versus Serratus Plane Block in Modified Radical Mastectomy
ClinicalTrials.gov ID: NCT07247448
Acronym / sponsor ID: PECB II & PIFB VS SAPB in MRM
Conditions: Pain Management
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 70 participants (estimated)
Lead sponsor: Assiut UniversityUniversity, hospital or other
Study start: 15 Oct 2025 (actual)
Primary completion: Nov 2026 (estimated)
Study completion: Nov 2026 (estimated)
First posted: 25 Nov 2025 (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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Patients: 70 patients will be enrolled in this study. They will be equally divided into two groups: Group A (PIFB-PECS II): 35 patients will receive 40 mL of 0.25% bupivacaine. * PECS II block divided into 2 injections. 1. 10 ml between the pectoralis major and pectoralis minor 2. 20 ml between the pectoralis minor and stratus anterior muscle * PIFB 10 mL between the pectoralis major and the intercostal muscle. Group B (Serratus plane block): 35 patients will receive 40 mL of 0. 25% bupivacaine.

Arm	Type	Receives
PIFB-PECS II	Active comparator	Procedure: PECS II block, Procedure: PIFB
SAPB	Active comparator	Procedure: SAPB block

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients scheduled for elective MRM
Age 18-65 years
American Society of Anesthesiologists (ASA) physical state I-II

Key exclusion criteria (6 listed)

Patient refusal.
Body Mass Index > 30 kg/m2.
Skin infection at the site of injection.
History of renal, liver, cardiac, and neuropsychiatric disorder problems.
Bleeding or coagulation abnormality.

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
PECS II blockUltrasound-Guided PECS II Block With the patient in a supine position, her arm in a neutral position, and under complete aseptic technique, a 6 to 13 MHz ultrasound linear transducer probe (Mindray, Shen zhen, China) will be positioned below the distal one-third of the clavicle to visualize the pectoralis major and minor muscles, SAM, pectoral branch of the thoracoacromial artery, the second and third ribs, and the external intercostal muscles between the ribs. The needle will be inserted in-plane in a medial-to-lateral direction until its tip is placed between the SAM and the external intercostal muscles. The first injection will be done below the SAM using 20 mL bupivacaine 0.25% at the level of the second rib to block the intercostobrachial nerves and the lateral branches of the third to the sixth intercostal nerves. The needle will be withdrawn until its tip is placed between the pectoralis major and minor muscles, and an additional 10 mL of bupivacaine 0.25% will be injected.	Procedure or surgery	PIFB-PECS II
SAPB blockUltrasound-Guided Serratus Anterior Plane Block (SAPB) The probe will be placed on the mid-axillary line at the level of the fourth rib to visualize the serratus anterior and latissimus dorsi muscles. After establishing the correct level, the needle will be introduced in-plane. After puncturing the serratus muscle and contacting the rib, 40 mL of bupivacaine 0.25% will be deposited between the serratus muscle fascia and the rib periosteum, termed a deep serratus anterior plane block.	Procedure or surgery	SAPB
PIFBUltrasound-Guided PIFB Under complete aseptic technique with the patient in the supine position, a 6 to 13 MHz ultrasound linear transducer probe (Mindray, Shen zhen, China) will be placed 2 or 3 cm parallel to the long axis of the sternal bone to identify the second to fourth costal cartilages and targeting the fourth costal cartilage The needle will be inserted in-plane with the US probe, in a caudal-to-cranial direction. The needle will be advanced until the tip is positioned in the interfascial plane between the pectoralis major muscle and the intercostal muscle. After confirmation of the correct position of the tip of the needle, as shown by separation of the fascial layers on injecting 2 mL normal saline solution, 10 mL of bupivacaine 0.25% will be injected.	Procedure or surgery	PIFB-PECS II

Primary outcome

The analgesic efficacy of PECS II-PIFB versus SAPB in patients scheduled for MRM by the total analgesic consumption (nalbuphine in mg) during the first 24 hours.
Time frame: 24 hours
The analgesic efficacy of PECS II-PIFB versus SAPB in patients scheduled for MRM by the total analgesic consumption (nalbuphine in mg) during the first 24 hours.

1 secondary outcome

Post operative Pain Scores
Time frame: 30 minutes, 1hours, 2hours, 4hours, 6hours, 8hours, 12hours and 24 hours

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
Results publicationPatel LP, Sanghvi PR, Agarwal MB, Prajapati GC, Patel BM. Thoracic paravertebral block for analgesia after modified radical mastectomy. Indian J Pain 2014;28:160-165.
Results publicationMisbah Mahmoud A., Said Ahmed A., Aly Salah A., Ahmed El-sayed N., Ali El Asser H., Mohamed Elsaed M. Ketamine Versus Dexmedetomidine as Adjuvants to Bupivacaine in Modified Pectoralis Plane Block for Analgesia in Patients Undergoing Modified Radical Mastectomy. Zagazig Univ Med J 2025.
Results publication: PubMed 15566531Jamieson S. Likert scales: how to (ab)use them. Med Educ. 2004 Dec;38(12):1217-8. doi: 10.1111/j.1365-2929.2004.02012.x. No abstract available.
Results publication: PubMed 29321111Karcioglu O, Topacoglu H, Dikme O, Dikme O. A systematic review of the pain scales in adults: Which to use? Am J Emerg Med. 2018 Apr;36(4):707-714. doi: 10.1016/j.ajem.2018.01.008. Epub 2018 Jan 6.
Results publication: PubMed 34733377Hu NQ, He QQ, Qian L, Zhu JH. Efficacy of Ultrasound-Guided Serratus Anterior Plane Block for Postoperative Analgesia in Patients Undergoing Breast Surgery: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. Pain Res Manag. 2021 Oct 25;2021:7849623. doi: 10.1155/2021/7849623. eCollection 2021.
Results publication: PubMed 37847921Hozien AI, Helmy AM, Koptan HM, Elfeil YE, Yakout MMS, Elwafa HBAA. Analgesic Effect of Addition of Pectointercostal Block to Serratus Anterior Plane Block in Breast Surgeries: A Randomized, Controlled Trial. Pain Physician. 2023 Oct;26(6):E679-E685.
Results publication: PubMed 36451631Jayadeep I, Srinivasan G, Sethuramachandran A, Elakkumanan LB, Swaminathan S, Bidkar P. Comparison of the Analgesic Efficacy of Ultrasound-Guided Superficial Serratus Anterior Plane Block With Deep Serratus Anterior Plane Block in Patients Undergoing Modified Radical Mastectomy: A Randomized Clinical Trial. Cureus. 2022 Oct 29;14(10):e30828. doi: 10.7759/cureus.30828. eCollection 2022 Oct.
Results publication: PubMed 17695343Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
Results publication: PubMed 28820803Woodworth GE, Ivie RMJ, Nelson SM, Walker CM, Maniker RB. Perioperative Breast Analgesia: A Qualitative Review of Anatomy and Regional Techniques. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):609-631. doi: 10.1097/AAP.0000000000000641.
Results publication: PubMed 28367293Hong B, Yoon SH, Youn AM, Kim BJ, Song S, Yoon Y. Thoracic interfascial nerve block for breast surgery in a pregnant woman: a case report. Korean J Anesthesiol. 2017 Apr;70(2):209-212. doi: 10.4097/kjae.2017.70.2.209. Epub 2017 Jan 12.
Results publication: PubMed 24289954Lopez-Matamala B, Fajardo M, Estebanez-Montiel B, Blancas R, Alfaro P, Chana M. A new thoracic interfascial plane block as anesthesia for difficult weaning due to ribcage pain in critically ill patients. Med Intensiva. 2014 Oct;38(7):463-5. doi: 10.1016/j.medin.2013.10.005. Epub 2013 Nov 26. No abstract available.
Results publication: PubMed 24396082de la Torre PA, Garcia PD, Alvarez SL, Miguel FJ, Perez MF. A novel ultrasound-guided block: a promising alternative for breast analgesia. Aesthet Surg J. 2014 Jan 1;34(1):198-200. doi: 10.1177/1090820X13515902. No abstract available.
Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results of this study will be made available to researchers upon reasonable request from the corresponding author after the publication of results, for a period of one year. The shared data will include anonymized variables relevant to the primary and secondary outcomes

Related trials for Pain Management

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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.

Mohammad Mahmoud Shaker, Bachelor's principal investigator

Assiut 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 PECS II block, SAPB block and PIFB in people with Pain Management, run by Assiut 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 6 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: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2025. 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?

This study is still under way. Results are not available in the source record yet.

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?

The analgesic efficacy of PECS II-PIFB versus SAPB in patients scheduled for MRM by the total analgesic consumption (nalbuphine in mg) during the first 24 hours. (time frame: 24 hours). 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 NCT07247448, which also lists 24 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 2 Dec 2025.